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Insulin Patent Expiration

March 2018 - When Will The Patents On Novolog Expire, And When Will Generic Novolog Be Available?

March 2018 - When Will The Patents On Novolog Expire, And When Will Generic Novolog Be Available?

For more informationtry a trial or see the plans and pricing Serving hundreds of leading biopharmaceutical companies globally: Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice. Continue reading >>

Insulin Patent Profile. April 2016

Insulin Patent Profile. April 2016

This study on insulin patents was undertaken as part of Addressing the Challenge and Constraints of Insulin Sources and Supply (ACCISS) Study. Insulin is an essential medicine that is needed for all people with type 1 diabetes, and a growing number of people with type 2 diabetes. It is crucially important that people in need can access this life-saving medicine. Patents confer a 20 year period in which the patented product has market exclusivity, therefore third parties need permission from the patent owner to manufacture the product. Whether or not patents on insulins are a barrier to access is an important issue. This research looked at which insulins are not patented, or no longer patented.Publicly-accessible databases from the United States (US), European, Chinese and Indian patent offices, as well as the US Food and Drug Administration (US FDA) and Health Canada, were reviewed to determine the patent status of human and analogue insulins. Patents on analogue insulins in the market in the US and Canada have already expired or will soon expire in these countries and elsewhere. Only four companies own these key patents: Novo Nordisk, Sanofi, Eli Lilly and Pfizer. Patents on these insulins are geographically restricted roughly to North America, Europe, Australia, and China. In general, where US or Canadian patents were detected, about half were found in high-income countries, a quarter in middle-income countries, and the remainder in lower-middle-income countries. Patents in low-income settings were rare. Patents and patent applications on insulins that are being developed have a wider geographic scope than insulins marketed in the US and Canada. Across the four companies, the patent expiration dates are delayed so any insulin patents that might eventually be granted Continue reading >>

Why People With Diabetes Can't Buy Generic Insulin

Why People With Diabetes Can't Buy Generic Insulin

Fast Facts: Drug companies have made incremental improvements that kept insulin under patent for more than 90 years. Insulin can cost $120 to $400 per month for patients with no prescription drug coverage. Many patients with diabetes have lapses in medication that can lead to serious complications requiring hospitalization. A generic version of insulin, the lifesaving diabetes drug used by 6 million people in the United States, has never been available in this country because drug companies have made incremental improvements that kept insulin under patent from 1923 to 2014. As a result, say two Johns Hopkins internist-researchers, many who need insulin to control diabetes can’t afford it, and some end up hospitalized with life-threatening complications, such as kidney failure and diabetic coma. In a study published March 19, 2015, in the New England Journal of Medicine, authors Jeremy Greene, M.D., Ph.D., and Kevin Riggs, M.D., M.P.H., describe the history of insulin as an example of “evergreening,” in which pharmaceutical companies make a series of improvements to important medications that extend their patents for many decades. This keeps older versions off the generic market, the authors say, because generic manufacturers have less incentive to make a version of insulin that doctors perceived as obsolete. Newer versions are somewhat better for patients who can afford them, say the authors, but those who can’t suffer painful, costly complications. “We see generic drugs as a rare success story, providing better quality at a cheaper price,” says Greene, an associate professor of the history of medicine at the Johns Hopkins University School of Medicine and a practicing internist. “And we see the progression from patented drug to generic drug as almost auto Continue reading >>

The Top 10 Patent Losses Of 2015

The Top 10 Patent Losses Of 2015

We have bad news and good news about patent expirations next year. The bad? When you tot up the billions of sales at risk of patent expiration in 2015, the result is $44 billion, the biggest number since the debacle of 2012. That year, $53 billion worth of drugs fell off patent--and many drugmakers are still reeling. But in 2015, generics are expected to take a much smaller bite from the drugs losing exclusive access to their respective markets. That's because several of the big expiries involve biotech drugs. Even if biosimilar versions of these meds--Amgen's ($AMGN) Neulasta, for instance--do make it to market in the U.S. next year, their impact on sales is likely to be limited. According to EvaluatePharma , only $16 billion in sales will actually be lost to patent expiration next year. That's way less than half. That's because biosimilar drugs may not be automatically substitutable for the brands they're seeking to replace. There's a battle going on over this exact issue: Biosimilar makers want their drugs to be labeled with the same generic names as the brands; branded drugmakers say biosims should carry their own unique names. If the biosim makers win, their drugs will more easily substitute for brands, digging deeper into brand sales when patents expire. If the unique-name advocates prevail, doctors will have to prescribe biosimilars specifically, and brands will be better insulated. "With forecasts now to 2020, we have an extended view of how equity analysts are modeling the impact of biological patent expiries and the subsequent entry of biosimilar products," Evaluate Pharma said in a recent report. "[T]hey continue to expect a softer landing, post-patent expiry, and limited biosimilar substitution. "It seems future metaphorical patent cliffs are being transfor Continue reading >>

Biosimilars Of Insulin Lispro Posted 18/08/2017

Biosimilars Of Insulin Lispro Posted 18/08/2017

Last update: 18 August 2017 Insulin glargine is a fast acting insulin analogue used to treat people living with Type 1 or Type 2 diabetes. Insulin lispro has one primary advantage over regular insulin for postprandial glucose control. It has a shortened delay of onset, allowing slightly more flexibility than regular insulin, which requires a longer waiting period before starting a meal after injection. Both types should be used in combination with a longer acting insulin for good glycaemic control. The originator product, Eli Lilly’s Humalog (insulin lispro), was approved by the US Food and Drug Administration (FDA) in June 1996 and by the European Medicines Agency (EMA) in April 1996 [1]. Humalog generated an estimated US$2.8 billion in net sales income globally for Eli Lilly in 2016. Humalog no longer has effective exclusivity through patent protection or data protection in either Europe or the US. Some of the insulin lispro biosimilars and non-originator biologicals approved or in development are presented in Table 1. Table 1: Biosimilars and non-originator biologicals* of insulin lispro approved or in development Company name, Country Product name Stage of development Biocon/Mylan, India*/USA - ‘Similar biologic’ currently under preclinical/ scale-up development Sanofi, USA Insulin lispro Sanofi Approved by EMA in May 2017 [1] EMA: European Medicines Agency. *See editor’s comment Sanofi’s insulin lispro biosimilar was approved by EMA’s Committee for Medicinal Products for Human Use on 19 May 2017 [1]. Generics giant Mylan and India-based Biocon have made an agreement to develop and market Biocon’s biosimilar versions of three insulin analogue products, which include Lantus, as well as Eli Lilly’s Humalog (insulin lispro) and Novo Nordisk’s NovoLog Continue reading >>

Generic Insulins Out Of Reach For Now

Generic Insulins Out Of Reach For Now

A Diabetes Health reader writes in to ask: Is there a generic alternative to Humalog insulin? If so, what is its cost compared to Humalog? Generic drugs are amazing. They offer lifesaving promise for a cheap price tag, and given that the underlying drugs have been tested and proven, there’s no doubt about safety or effectiveness. But don’t expect to see generic “human” insulin any time soon. If you do spot it eventually, don’t expect it to be too cheap or widespread. It seems that the complex manufacturing involved in insulin drugs isn’t easily duplicated. The processes are so complicated–and government guidance in the area so lacking–that there are still no generic alternatives to insulin brands with expired patents in the United States. Humulin insulin, for example, saw its patent expire in 2000, but Eli Lilly still sold $1.3 billion worth of the brand last year. Lilly’s patent on Humalog will expire next year, but its most worrisome competitor, a company in India associated with Pfizer, called off its generic insulin work in March. That’s expected to keep Humalog sales strong into the near future. Some semi-generic forms of human insulin are available in other countries, but they’re called “biosimilars” because they’re only similar, not identical, to the name brand stuff. Patients don’t necessarily react to them in the same way. The US Department of Health and Human Services is working on rules for these generic insulins, and a plant to manufacture them is being built. But companies will still have to run tests on the new insulins–something they don’t have to do for most other generic drugs–which will slow their introduction even further. Ultimately, insulin is a highly specialized drug that’s used by a relatively small number of Continue reading >>

The Insulin Market Is Heading For A Shakeup. But Patients May Not Benefit

The Insulin Market Is Heading For A Shakeup. But Patients May Not Benefit

The insulin market, dominated by old drugs that have skyrocketed in price, is on the verge of a shakeup. The first “follow-on” insulin for diabetics, similar to a generic medication for synthetic drugs, will hit the market in December. It’s expected to be followed in the coming months and years by a wave of new follow-on and “biosimilar” insulins that have the same protein structures as brand-name products. Experts predict that these new insulins will carry lower prices — but it’s far from certain that the competition will drive down costs overall. The stakes are high: About 6 million Americans with diabetes use insulin, either alone or in combination with an oral drug. The annual cost of insulin reached $736 per patient in 2013, up threefold since 2002. Diabetes medicines, including insulin, are the second most expensive category of prescription drugs, according to Express Scripts, the big pharmacy benefits manager. Here’s what you need to know about how insulin prices got so high — and what you should expect from the coming shifts in the market. What’s on the market now? The vast majority of diabetics who need insulin choose from a menu of a half-dozen “analog” brands, which are chemically altered from natural human insulin. They’re manufactured by just three different drug makers: Novo Nordisk, Sanofi-Aventis, and Eli Lilly. Some are long-acting insulins, injected once or twice a day; others act rapidly and patients inject or deliver them with a pump as needed. Many patients use both. A few of these products — like Novo Nordisk’s Tresiba and Sanofi’s Toujeo, which are both long-acting — have only been on the market a matter of months, and aren’t yet widely used. But the others have generally been around for at least a decade, and s Continue reading >>

The Revenue Challenge Ahead For Eli Lilly And Co

The Revenue Challenge Ahead For Eli Lilly And Co

One of the toughest pills investors have to swallow when investing in big pharma is the constant challenge of patent expiration. Blockbuster drugs that were generating billions of dollars in revenue can suddenly disappear from the income statement as their patents expire and generic competition enters the picture. Losing a single drug can be painful enough, but investors can get really hurt when several key drugs lose patent protection around the same time. Just ask an Eli Lilly and Co (NYSE:LLY) investor, and they'll tell you all about it. Patent expirations of blockbuster drug Zyprexa, Cymbalta, and Evista have taken a toll on the company's financials over the last few years. After revenue and earnings per share (EPS) peaked in 2011, the company has struggled to make up for the shortfall, and earnings have fallen by more than 50% since. As difficult as these revenue losses have been for the company over the fast few years, it looks like there could be more pain on the way. Lilly has several key drugs that will be coming off patent in the next few years: When you add up how much each drug brings in, the total represents a massive 48% of Lilly's 2014 revenue that could be at risk in the next few years. Altima alone was responsible for 14% of Lilly's 2014 revenue, and it will see its first leg of international patent protection disappear in December of this year. 2017 in particular appears to be an especially rough year for the company, as Alitma, Cialis, Strattera, and Effient all lose at least a portion of their stateside patent protection. The biosimilar threat? It should also be noted that Lilly has two key drugs currently driving billions of dollars in sales that are not on that list. Why aren't they on the list? Their patents have already expired! Humalog and Humul Continue reading >>

How Drug Companies Keep Insulin Prices High

How Drug Companies Keep Insulin Prices High

New research examines why people with diabetes who depend on injections of lifesaving insulin still have no cheaper generic options to treat their disease. "Surprisingly, this issue has not been talked about, so we're asking the question: Why is there no generic insulin?" said senior study author Dr. Kevin Riggs, a research fellow at Johns Hopkins University School of Medicine in Baltimore. In their report, published March 19 in the New England Journal of Medicine, Riggs and his colleague Dr. Jeremy Greene describe how the unique development of insulin allowed pharmaceutical companies to continually improve the medication while extending patents for decades. Generic drugs cannot be made until a patent on a brand-name drug expires. One expert pointed out the possible repercussions. "This is a big issue. Some patients simply cannot afford to pay for the insulin that keeps their blood sugar down, even people who have health insurance," explained Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center in New York City. He added that if insulin prices remain out of reach for some, the health care system will end up paying more in hospitalizations and treatments for complications related to undertreated or untreated diabetes. The cost of insulin for someone who doesn't have insurance runs from $120 to $400 a month, the researchers noted. Insulin is a naturally occurring hormone that's necessary for the body to use the sugars found in foods as fuel for the cells in the body and brain. In people with type 1 diabetes, the body's immune system mistakenly attacks the insulin-producing cells (called beta cells) in the pancreas. This destroys their ability to make enough insulin to survive. People with type 1 diabetes must inject insulin to stay aliv Continue reading >>

Soaring Insulin Prices Are A Case In Point: A 'free Market' In Healthcare Is Doomed

Soaring Insulin Prices Are A Case In Point: A 'free Market' In Healthcare Is Doomed

A key feature of Republican plans to replace Obamacare is allowing market forces to boost innovation and competition among healthcare providers. “Unleashing the power of choice and competition is the best way to lower healthcare costs and improve quality,” declares House Speaker Paul Ryan in his conservative manifesto “A Better Way.” The problem with that, however, is that the healthcare industry — hospitals, drug companies, insurers — have worked tirelessly to prevent the medical marketplace from functioning with sufficient transparency and efficiency to allow consumers to benefit from classic supply-and-demand economics. Instead, the opaque and frequently unfathomable healthcare market promotes runaway corporate greed that often can be countered only by shaming businesses into behaving fairly and responsibly. Insulin is a perfect example. Pharmaceutical giant Eli Lilly announced last week that people with diabetes in high-deductible insurance plans or who are otherwise paying full price for insulin will be eligible for a 40% discount. The move follows Danish insulin maker Novo Nordisk announcing it will limit annual price increases to single digits. However, it’s not like the heads of these companies woke up one morning and realized they’d been despicably taking advantage of people with a chronic disease. Rather, they’re facing heat from lawmakers and are desperate to make a show of sensitivity before anyone demands that they appear on Capitol Hill to explain themselves — as other drugmakers have been forced to do. Sen. Bernie Sanders and Rep. Elijah Cummings said in a letter to the Justice Department and Fair Trade Commission last month that officials need to look into whether drug companies “colluded or engaged in anticompetitive behavior” in Continue reading >>

Insulin’s Inventor Sold The Patent For $1. Then Drug Companies Got Hold Of It.

Insulin’s Inventor Sold The Patent For $1. Then Drug Companies Got Hold Of It.

Frederick Banting wasn’t a dude who backed down. The Army refused him due to poor eyesight in 1914; in 1915, he tried again and got in. He got rejected from a Toronto hospital in 1919; he set up his own successful practice in 1920. So it’s not a surprise that Banting did what other scientists and doctors had struggled to do for decades: discovered and refined insulin therapy. His three-person team knew that this treatment was both urgently needed and incredibly tricky to get right; they wanted to make sure the public could access it, and that it was safe. So they made a move for the common good: saying that profit was not their goal, they sold the patent for insulin to the University of Toronto for just $1 each. The University then gave pharmaceutical companies the right to manufacture the drug royalty-free. It made sense at the time; Banting and his team were worried that if they didn’t patent the drug at all, drug companies would rush to patent an inferior, possibly dangerous version and try to turn huge profits on it. The thinking seems to have been that if drug companies didn’t have to pay royalties, they would keep prices low. The thinking was wrong. Less than thirty years later, drug manufacturer Eli Lilly and Company and two other companies were indicted for an insulin price-fixing scheme. But that was only the beginning: in the late seventies, the process for synthetic insulin was perfected, making it far easier and less risky to produce. Since then, prices have been on a sharp uphill climb with no end in sight. Insulin is a billion-dollar industry with zero low-priced generic versions on the market. While most name-brand drugs have generic versions that cost less than half the price, insulin is different. Miriam Tucker at Medscape explains: Insulin’s Continue reading >>

Where's The Generic Insulin?

Where's The Generic Insulin?

You can buy generic birth control pills, HIV antivirals, and chemotherapy drugs, but you can't buy generic insulin; it doesn't exist. In fact, the history of insulin in the United States is a case study for how the brand-name-then-generic system can fail patients. Generic insulin would certainly be a big boon to many Americans, five million of whom depend on insulin to manage their Type 1 and Type 2 diabetes, illnesses that are deadly when left untreated. For those without insurance, brand-name insulin costs $120 to $400 for a month's supply. In 2014, the website Insulin Nation interviewed insulin users about their troubles. One person gave up doctor's visits and teeth cleanings to buy her medicine. Another stocked up when he found it for a good price, and sent extra to a family member who couldn't afford it. Normally, companies start creating generics when big-name drug-makers' patents expire. The generics sell for less because their makers didn't bear the cost of discovering and developing the drugs. This should have happened to insulin already—the first patent for it dates to 1923. But a combination of patent-refreshing and generics companies' reluctance to tackle making the insulin protein, which is hard to copy, has kept insulin patented and pricey, two physician-researchers report in the New England Journal of Medicine today. "It's hard to say that contemporary patients who cannot afford their insulin are well served by having as their only option an agent that is marginally more effective than those that could have been generically available 50 or 30 or 10 years ago." In recent years, some researchers and journalists have called out drug companies for "evergreening," or making trivial improvements to drugs whose patents are close to expiring. The tweaks let com Continue reading >>

The Global Intellectual Property Ecosystem For Insulin And Its Public Health Implications: An Observational Study

The Global Intellectual Property Ecosystem For Insulin And Its Public Health Implications: An Observational Study

Journal of Pharmaceutical Policy and Practice Lack of access to insulin and poor health outcomes are issues for both low and high income countries. This has been accompanied by a shift from relatively inexpensive human insulin to its more expensive analogs, marketed by three to four main global players. Nonetheless, patent-based market exclusivities are beginning to expire there for the first generation insulin analogs. This paper adds a global dimension to information on the U.S. patent landscape for insulin by reviewing the patent status of insulins with emphasis on the situation outside the US and Europe. Using the term insulin, we searched for patents listed on the United States Food and Drug Administrations (USFDA) Orange Book and the Canadian Online Drug Product Database Online Query and its Patent Register. With this information, we expanded the search globally using the World Intellectual Property Organization (WIPO) PatentScope database, the European Patent Offices INPADOC database and various country-specific Patent Offices. Patent protected insulins marketed in the U.S. and other countries are facing an imminent patent-expiration cliff yet the three companies that dominate the global insulin market are continuing to file for patents in and outside the U.S, but very rarely in Africa. Only a few local producers in theso-called "pharmerging"markets (e.g., Brazil, India, China) are filing for global patent protection on their own insulins. There is moderate, but statistically significant association between patent filings and diabetes disease burden. The global market dominance by a few companies of analog over human insulin will likely continue even though patents on the current portfolio of insulin analogs will expire very soon. Multinationals are continuing t Continue reading >>

Why Treating Diabetes Keeps Getting More Expensive

Why Treating Diabetes Keeps Getting More Expensive

Laura Marston is one of the 1.25 million Americans who suffer from Type 1 diabetes, an autoimmune disorder in which a person's pancreas can't make insulin. She hoards vials of the life-saving medicine in her refrigerator to protect herself from the drug's rising prices. (Jorge Ribas/The Washington Post) At first, the researchers who discovered insulin agonized about whether to patent the drug at all. It was 1921, and the team of biochemists and physicians based in Toronto was troubled by the idea of profiting from a medicine that had such widespread human value, one that could transform diabetes from a death sentence into a manageable disease. Ultimately, they decided to file for a patent — and promptly sold it to the University of Toronto for $3, or $1 for each person listed. It was the best way, they believed, to ensure that no company would have a monopoly and patients would have affordable access to a safe, effective drug. “Above all, these were discoverers who were trying to do a great humanitarian thing,” said historian Michael Bliss, “and they hoped their discovery was a kind of gift to humanity.” But the drug also has become a gift to the pharmaceutical industry. A version of insulin that carried a list price of $17 a vial in 1997 is priced at $138 today. Another that launched two decades ago with a sticker price of $21 a vial has been increased to $255. [This 90-year-old fight over insulin royalties reveals just how much has changed in medicine] Seventy-five years after the original insulin patent expired — a point at which drug prices usually decline — three companies have made incremental improvements to insulin that generate new patents and profits, creating a family of modern insulins worth billions of dollars. The history of insulin captures Continue reading >>

Insulin Price Hikes Tell Us A Lot About What's Wrong With Drug Pricing In America

Insulin Price Hikes Tell Us A Lot About What's Wrong With Drug Pricing In America

Ballyscanlon/Getty Images When inventor Frederick Banting discovered insulin in 1923, he refused to put his name on the patent. He felt it was unethical for a doctor to profit off a discovery that would save lives. Banting’s co-inventors, James Collip and Charles Best, sold the insulin patent to the University of Toronto for a mere $1. They also wanted everyone who needed their medication to be able to afford it. Today Banting and colleagues would be spinning in their graves: Their drug, which many of America’s 30 million diabetics rely on, has become the latest poster child for pharmaceutical price gouging. On May 2, the pharmaceutical giant Eli Lilly raised the prices of its insulin medications, Humalog and Humulin, by 7.8 percent, according to newly obtained records from CNBC’s Meg Tirrell. And Lilly is not acting alone: Sanofi and Novo Nordisk, the only two other companies that manufacture insulin in the US, have been jacking up insulin prices recently too. Patients can now expect to pay upward of $400 per month for the century-old drug. Drug companies use the “cost of innovation” argument to justify the price increases — but critics don’t buy their reasoning, and diabetics who depend on the daily lifesaving medication are livid. In January, patients filed a class action lawsuit accusing the three companies of price fixing. The American Diabetes Association's board of directors has also asked Congress to investigate insulin price increases. While the US represents only 15 percent of the global insulin market, it generates almost half of the pharmaceutical industry’s insulin revenue. According to a recent study in JAMA Internal Medicine, in the 1990s Medicaid paid between $2.36 and $4.43 per unit of insulin; by 2014, those prices more than tripled, de Continue reading >>

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