Market Place
FDA’s June 2023 list of off-patent, off-exclusivity drugs sees steep rise in new drug applications
This week, PharmaCompass brings you the key highlights of the US Food and Drug Administration’s June 2023 list of Off-Patent, Off-Exclusivity Drugs without an Approved Generic (“OPOE list”). The OPOE list gets updated every six months.
Since December 2021, FDA has been publishing two versions of the OPOE list, one for prescription (Rx) drug products and the other for over-the-counter (OTC) drug products that are approved and marketed under a new drug approval (NDA).
With this list, the FDA hopes to bolster competitiveness in the generics market. Such updates are a part of FDA’s initiative to improve transparency and encourage the development and submission of abbreviated new drug applications (ANDAs) in markets with little competition.
View FDA's June 2023 list of Off-Patent, Off-Exclusivity Drugs (Free Excel Available)
Sharp rise in new applications; injectables make up for a third of Rx drug products
Almost one-third of the prescription products – 176 out of 500 – are drug products delivered as injectables while there are 76 entries for oral solid dosage forms (such as tablets, capsules and modified release forms).
The June 2023 list has a total of 60 OTC drug products. These include antiseptic agent chlorhexidine gluconate, non-steroidal anti-inflammatory drug ibuprofen, anti-allergy drug loratadine and painkiller acetaminophen. Out of the 60 OTC drug products on the list, 19 are delivered as oral solid dosage forms (such as tablets, capsules, modified release forms, etc.).
View FDA's June 2023 list of Off-Patent, Off-Exclusivity Drugs (Free Excel Available)
First generic of AstraZeneca’s Symbicort gets launched in US
This year, several large-selling drugs from drugmakers like Johnson & Johnson, Takeda, AstraZeneca, Roche and others are due to face their first generic or biosimilar challengers in the US.
As the name suggests, “first generics” are the first approvals handed by the FDA to manufacturers to market a generic product in the United States. The agency considers first generics to be important to public health, and prioritizes review of these submissions.
Among the more popular drugs, Viatris and Kindeva Drug Delivery launched Breyna (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol this month. This is the first generic version of AstraZeneca’s Symbicort. Breyna is a metered-dose inhaler that relaxes muscles in the airways to improve breathing. It is indicated for certain patients with asthma or chronic obstructive pulmonary disease (COPD).
View FDA's June 2023 list of Off-Patent, Off-Exclusivity Drugs (Free Excel Available)
Our view
Over the last few years, we have noticed FDA’s intent to bring down drug prices. While the sharp rise in new applications for prescription drugs only reinforces that trend, we also need to keep in mind that margins in the generics business have been going down and many large drugmakers are planning to reduce their focus on generics. This leaves more opportunities for smaller players to capture a larger piece of the US market for generics.
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Image Credit : FDA's List of Off-Patent, Off-Exclusivity Drugs with No Approved Generics (Mid-2023 Recap) by PharmaCompass license under CC BY 2.0
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