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    FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments

    FDA’s June 2024 list of off-patent, off-exclusivity drugs sees rise in cancer, HIV treatments

    This week PharmaCompass brings to you key highlights of the US Food and Drug Administration’s recently released June 2024 list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (OPOE list). The list is a crucial resource for promoting competition and affordability in the pharmaceutical industry. Updated biannually in December and June, the OPOE list serves as a transparent guide for drug manufacturers. Since December 2021, the FDA has enhanced its transparency efforts by providing separate lists for prescription (Rx) and over-the-counter (OTC) drugs approved under a New Drug Application (NDA). This initiative is a significant cog in the FDA’s broader strategy to encourage the development and submission of Abbreviated New Drug Applications (ANDAs). ANDAs are a streamlined pathway for generic drug development, offering a more cost-effective alternative to brand-name drugs. By highlighting drugs that lack generic competition on the OPOE list, FDA aims to incentivize manufacturers to develop generics, ultimately leading to greater affordability and access for patients. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel) ALS drugs, cancer, asthma, HIV treatments among new drugs added to OPOE list The December 2023 OPOE list had 23 new applications of branded drugs eligible for but without generic competition. The June list further added 21 new applications of drugs that had never appeared before. These include bendamustine hydrochloride (to treat chronic lymphocytic leukemia), fluticasone propionate (to treat asthma), maraviroc (to treat HIV-1 infection in patients two years of age and older weighing at least 10 kilograms), carbamazepine (to treat epilepsy and bipolar I disorder), and posaconazole (an antifungal agent indicated for Aspergillus and Candida infections). There are two other drugs on the list – edaravone and riluzole – to treat amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease (a neurological disorder).  Much like the June 2023 OPOE list, nearly one-third of the prescription drugs listed are injectables – 170 out of 499. There are 74 prescription entries for oral solid dosage forms (such as tablets, capsules and modified release forms). The June 2024 OPOE list has 57 OTC drugs, a tad shy of the 60 drugs in last year’s list. Among them are antihistamine drugs (used to treat allergies), cetirizine hydrochloride, nizatidine, famotidine, loratadine and anti-obesity medication orlistat. The list also had a newly listed drug, which is a combination of chlorpheniramine maleate, ibuprofen and pseudoephedrine hydrochloride for treating allergic sinusitis. Out of the 57 OTC drug products on the list, 18 are delivered as oral solid dosage forms. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Novartis blockbusters lose exclusivity, Lupin wins FDA nod for copycat of Neurocrine’s bestseller This year, several large-selling drugs from drugmakers like Eisai, AbbVie, Gilead, Sanofi, Fresenius Kabi and others are due to face their first generic or biosimilar challengers in the US market. “First generics” are given for a first-to-file ANDA, for which there is no previously-approved ANDA by the FDA for the drug product. The agency considers first generics to be important to public health and prioritizes review of these submissions. First generics are eligible for a 180-day exclusivity period.  Three of Novartis’ drugs have lost exclusivity so far, this year. These include Promacta/Revolade (eltrombopag) used to treat thrombocytopenia (low platelet count). Promacta was approved in 2015 and saw sales of US$ 2.27 billion last year. Annora Pharma scored an FDA approval for eltrombopag’s first generic in April. Tasigna (nilotinib), the Swiss drugmaker’s oral treatment for Philadelphia chromosome-positive chronic myeloid leukemia (a kind of leukemia where patients have an abnormal chromosome in their blood cells called the Philadelphia chromosome), got its first generic in January, which was introduced by Apotex. Tasigna brought in sales of US$ 1.85 billion in 2023 and its sales are projected to plummet to US$ 79 million by 2029. Novartis’ Rydapt (midostaurin) for treating adult patients with newly diagnosed acute myeloid leukemia (AML) also lost exclusivity in April. Neurocrine Biosciences’ top-selling drug Ingrezza (valbenazine) was the first FDA-approved drug to treat tardive dyskinesia, a disorder that involves involuntary movements. It raked in US$ 1.84 billion in 2023, registering a year-on-year growth of 29 percent. In April, Lupin won FDA’s approval for the first generic of valbenazine capsules. Access the Interactive Dashboard on FDA's June 2024 List of Off-Patent Drugs (Free Excel)  Our view The Biden administration has been pushing hard to lower the price of prescription drugs. It is one of President Joe Biden’s central campaign promises this year. However, lowering drug prices is a bipartisan issue in the US. So whether a republican or a democrat takes over the US administration, making medicines affordable should remain a priority. In 2023, generic drugs accounted for US$ 424 billion of the US$ 1.6 trillion global pharmaceutical market. A determined FDA that is proactively looking to approve generic drugs will no doubt help this segment grow even further.  

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    https://www.pharmacompass.com/radio-compass-blog/fda-s-june-2024-list-of-off-patent-off-exclusivity-drugs-sees-rise-in-cancer-hiv-treatments

    #PharmaFlow by PHARMACOMPASS
    11 Jul 2024
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    Pharma Chess: Strategies adopted in the United States to block generics

    Pharma Chess: Strategies adopted in the United States to block generics

    When a generic drug comes to the U.S. market, sales of brand drugs crash. The drop is more than 80% by the time a second- or third- generation generic arrives.For brand companies, used to high profits for years, the imminent generic threat leads to an aggressive search for ‘solutions’, and creative strategies to maximize returns from their products. What kind of blocking tactics are used to stop generic competition?In an attempt to delay generic competition, here are some of the commonly used approaches. 1/ Go legal:While a new drug patent is difficult to invent around, there are brand drugs with weak patents which may not withstand scrutiny. In such cases, the brand drug manufacturer files a patent infringement complaint with the FDA. The mere filing of the complaint triggers an automatic 30-month stay of FDA approval, as per the provisions of the Hatch-Waxman Act. Understanding the Hatch-Waxman Act:In 1984, a United States federal law was designed to encourage the manufacture of generic drugs by  pharmaceutical industry. The amendments of the Act protect the first generic (the ‘first-filer’) to challenge the brand’s patent, by mandating that the FDA not approve any additional generic competitors until 180 days, after the first-filer launches its product. 2/ Sample obstruction:Brands attempt to prevent generic firms from accessing samples of the brand drug necessary to perform equivalence studies. The reason provided is that the brand drug falls under restricted distribution, part of the FDA-mandated programs, known as Risk Evaluation and Mitigation Strategies (REMS). Brand firms also implement distribution restrictions for drugs that are not subject to REMS.3/ Destroy the product:Brand name pharmaceutical companies try to preserve the profits on a patented drug by making modest reformulations that offer little or no therapeutic advantages. This tactic is known as ‘product-switching’ or ‘product hopping’. In addition, prior to a generic launch, the brand drug simply withdraws its original product forcing patients to switch to the reformulated drug, so consumers don’t benefit from generic competition of the old version of the drug. Actavis’ ongoing Namenda litigation covers this example perfectly.4/ Change the rule of the game:In order to overcome the patents of the brand drugs, generic medicines are manufactured slightly differently, when compared with the brand product. Citizen petitions are filed with the FDA, at the behest of brand manufacturers, questioning the safety of the generic drug, due to the difference between the brand and generic products. A successful petition, changes the regulatory requirements, and makes it harder for generics to obtain FDA approval. The brand manufacturers were filing so many frivolous citizen petitions that the FDA has been denying them in record numbers. In the event, generic companies do manage to make significant inroads, and threaten the brand drug’s monopoly, there is a ‘pay-for-delay’ playbook. How does the ‘pay-for-delay’ game get played?Settlements are reached between brand and generic manufacturers in which the brand incentivizes the generic not to market their products. The incentives can involve any of the following options:- Cash payment made from the brand to the generic that claims to reimburse some or all of the generic’s litigation fees.- A side business deal between brand and generic manufacturers such as an agreement to buy active pharmaceutical ingredient (API) from the generic manufacturer, even though the brand has adequate supply of the API for their own needs (e.g. AstraZeneca, Ranbaxy’s Nexium deal).- Brand manufacturer promises not to market an Authorized Generic (AG) in competition with the generic manufacturer’s product for some period of time. AGs are pharmaceutical products, which are approved as brand-name drugs, but marketed as generic drugs. No authorized generics significantly reduce the competition for the generic player allowing them to secure greater market share and extract higher prices: e.g. GlaxoSmithKline (GSK) paid Teva Pharmaceuticals to delay entry by promising not to compete with authorized generic versions of the drug Lamictal.- Brand allows the generic to market an authorized generic of a different product: e.g. AbbVie’s Androgel case against Teva had Teva asking for supply of an authorized generic of TriCor, a cholesterol drug with 2011 sales of more than $1 billion. - Other forms of compensation are offered to the generic patent challenger. For example, an agreement containing a declining royalty structure in which, the intellectual property is licensed by the brand to the generic. Alternativelly, a co-development deal can be struck for a new drug. Our view:The battle between brands and generics will continue for time to come, and regardless of antitrust scrutiny, there will be a high degree of innovation in the strategies devised by brand firms to maximize profits. However, drug companies aren’t the only ones innovating. Hayman Capital wins our vote for the most innovative approach taken. The hedge fund’s “Dispute the patent, short the stock” formula is designed to try and make money regardless of the outcome. How exactly the healthcare system benefits from these different approaches is a completely different story!Click here and learn about the latest ‘pay-for-delay’ cases in Europe and America  

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    https://www.pharmacompass.com/radio-compass-blog/pharma-chess-strategies-adopted-in-the-united-states-to-block-generics

    #Phispers by PHARMACOMPASS
    04 Jun 2015
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