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Two dozen drugs could go generic this year and next, but the biggest change could happen in Congress

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Patents on 24 drugs will expire between the end of 2018 and the end of 2019, leaving them open for generic competition, according to data compiled by a company that aggregates pharmaceutical patent information.

But while the list, published by DrugPatentWatch.com, includes a wide variety of medicines, it’s in Congress that some of the most significant change could occur.

The CREATES Act – whose name stands for Creating and Restoring Equal Access To Equivalent Samples – was introduced last year by Democratic Sen. Patrick Leahy of Vermont. The stated goal is to facilitate timely entry of generics onto the market by making it easier for generic drugmakers to obtain product samples of branded drugs to develop their own versions.

Generics industry trade group the Association for Accessible Medicines anticipates that the bill, which enjoys bipartisan support, could see action in Congress next year, said Michael Brzica, the organization’s vice president for federal government affairs. “Drug pricing is going to be top of the agenda for both parties,” he said in a phone interview. “This really represents one of the ready-at-hand solutions to the problem that both parties are trying to solve.”

Brzica said the bill contains two critical components. One is that it maintains the Food and Drug Administration’s “proper role” in ensuring the safety of the drug supply. Second, it creates a guidance saying that when a generic pharmaceutical or biosimilar developer wants to acquire samples of a branded drug that has a higher risk profile, it has to go to the FDA and prove it can handle the drug appropriately and safely. The agency will then issue a certificate to buy the product from a company that has been slow or recalcitrant in selling samples on the open market.

The bill puts into law the intent behind a list the FDA published earlier this year naming branded drugmakers that had been the subject of complaints from generic companies about difficulty obtaining samples to make generic versions of their products. The list is meant to highlight ways in which restricted distribution of drugs – whether by drugmakers themselves or through Risk Evaluation and Mitigation Strategies, or REMS – prevent generic drugmakers from obtaining needed samples.

“We think the legislation is going to be more controlling than nonbinding guidances from the agency,” Brzica said.

Meanwhile, in terms of branded drugs coming off patent, the last one for this year will be Valeant’s Elidel (pimecrolimus), a topical cream for dermatitis, which loses patent protection on Dec. 26. Merck & Co.’s osteoporosis drug Fosamax Plus D (alendronate sodium) will follow, on Jan. 17.

One particularly significant patent expiration will be for Tecfidera (dimethyl fumarate), a multiple sclerosis treatment and the top-selling drug of Biogen, generating $4.2 billion in global revenues last year and more than $3.1 billion so far this year. Last week, Biogen pulled out of a $1 billion partnership with Gainesville, Florida-based Applied Genetic Technologies Corporation, or AGTC, after topline interim data from its Phase I/II study of a gene therapy for a rare eye disease showed the therapy was ineffective.

Nearly 20 additional drugs will also go off patent next year, topped off by Novartis’ topical corticosteroid Durezol (difluprednate), on Dec. 13, 2019.

DrugPatentWatch.com publisher Yali Friedman said in a phone interview that most of the exciting actions on drug patents he foresees are years out, such as earlier than expected generic entry through patent challenges. “For the drugs that are coming off next year, those are not the ones where you’re going to be looking for surprises per se,” he said. “It’s the ones that have patents that extend way into the future.”

Photo: Stas_V, Getty Images

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