This
week, PharmaCompass brings you key highlights of the US Food and Drug Administration’s December 2025 list of Off-Patent, Off-Exclusivity Drugs
(OPOE) without an approved generic. The OPOE list gets updated every six
months.This
list highlights drug products that have lost patent protection and regulatory
exclusivity, but remain without approved generic competition in the US market.
With this list, the FDA hopes to bolster competitiveness in the generics
market, improve transparency and encourage the development and submission of
abbreviated new drug applications (ANDAs) in markets with little competition.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). Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)Injectables continue to dominate FDA’s OPOE Rx list; 73 OTC drugs figure in Dec listFDA’s December 2025 OPOE Rx list includes 784 drug products that currently have no approved generics. Out of these, 297 are injectables and 126 are oral solid dosage forms (such as tablets, capsules and modified release forms). In June 2025, the OPOE Rx list had 765 drug products without an approved generic, out of which 304 were injectables, while 109 were oral solid drug forms. The
increase in drug products from 765 to 784 from June 2025 to December 2025 was
due to the inclusion of additional dosage strengths in the OPOE Rx list.
Otherwise, no new drugs were added to the December 2025 OPOE Rx list.The December 2025 OPOE list has 73 OTC drugs, slightly higher than the 69 drugs in the June 2025 list. Among the 73, 21 are oral solid dosage forms.Among
the OTC drugs on the December 2025 OPOE list are ibuprofen and ibuprofen sodium (for pain and inflammation),
pseudoephedrine hydrochloride and phenylephrine hydrochloride (nasal decongestants), nizatidine and famotidine (for gastroesophageal reflux
disease), loratadine, cetirizine hydrochloride and chlorpheniramine maleate (for allergy relief), loperamide hydrochloride (anti-diarrheal), and
orlistat (for weight management). Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel)FDA fast-tracks initiatives to accelerate market entry of generics, biosimilarsFDA has launched several regulatory initiatives designed to accelerate the market entry of generics and biosimilars. In October 2025, the agency announced a new pilot prioritization program for the review of
ANDAs that aims to encourage and reward investment in drug manufacturing,
research and development and strengthen the pharmaceutical supply chain in the
United States.Separately,
FDA has also come out with a new draft guidance that seeks to simplify
biosimilarity studies and reduce unnecessary clinical testing. Through a
separate initiative, the agency also plans to make it easier for biosimilars to
be developed as interchangeable with brand-name biologics, thereby helping patients
and pharmacists choose lower-cost options. Access the Interactive Dashboard on FDA's December 2025 List of OPOE Drugs (Free Excel) Our viewThe
global generic drugs market was valued at US$ 445.62 billion in 2024 and is projected to
reach US$ 728.64 billion by 2034, growing at a compound annual growth rate of
5.04 percent from 2025 to 2034. With several diabetes, immunology,
oncology and cardiology drugs slated to face patent expirations this year, and
continued pressure on drugmakers to improve affordability, we believe the
generic market could grow at an even faster rate in the near term.
Share