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DATA COMPILATION #PharmaFlow

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FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs
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, 296 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.

Impressions: 1363

https://www.pharmacompass.com/radio-compass-blog/fda-opoe

#PharmaFlow by PHARMACOMPASS
22 Jan 2026

STOCK RECAP #PipelineProspector

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Pipeline Prospector Jan 2026 highlights: Astra, CSPC sign up to US$ 18.5 bn obesity deal; Wegovy’s pill version debuts in US
The year 2026 began amid heightened geopolitical tensions, particularly over Greenland. The US President Donald Trump threatened 25 percent tariff on several European countries until the US is allowed to purchase Greenland, a semi-autonomous Danish territory. These threats escalated transatlantic tensions and drew strong pushback from European nations and NATO.Despite this, biotech indices grew steadily through the month. The Nasdaq Biotechnology Index (NBI) rose 2.26 percent in January, moving from 5,723.48 to 5,852.67. The SPDR S&P Biotech ETF (XBI) gained 2.03 percent, climbing from 122.27 to 124.75, while the S&P Biotechnology Select Industry Index (SPSIBI) increased 2.29 percent, rising from 9,528.24 to 9,746.25.The month also saw Big Pharma continuing to pledge investments in the US to avert tariffs. January is also the month of JP Morgan healthcare conference. This year, the meet (or JPM26) saw announcements of several important deals, especially in the sphere of obesity drugs and the use of artificial intelligence in drug discovery. Access the Pipeline Prospector Dashboard for January 2026 Newsmakers (Free Excel)Astra, CSPC sign up to US$ 18.5 bn obesity deal; AbbVie to invest US$ 100 bn in USAstraZeneca made a lot of news last month. It signed an up to US$ 18.5 billion licensing deal with China’s CSPC Pharmaceutical Group for its  experimental obesity and weight-related drug candidates. AstraZeneca will pay US$ 1.2 billion upfront and up to US$ 17.3 billion in milestones. The package includes a clinical-ready and three pre-clinical candidates in CSPC’s injectable weight-management portfolio. AstraZeneca will also collaborate with CSPC on four additional new programs using CSPC’s sustained-release delivery platform and AI-driven peptide drug discovery. Besides this deal, AstraZeneca also announced a US$ 15 billion investment in China through 2030 to expand medicines manufacturing and R&D, including capabilities in cell therapy and radio-conjugates.In the US, pharma companies continued to announce investments to avoid import tariffs threatened by Trump. AbbVie pledged US$ 100 billion into its US research, development and manufacturing operations over the next 10 years. This is, by far, the biggest commitment announced by a drugmaker. Coming in at a distant second is Johnson & Johnson, which had announced US$ 55 billion in US-based investments in March.Similarly, Eli Lilly said it will build a US$ 3.5 billion manufacturing plant in Pennsylvania to produce injectable weight-loss medicines, with construction expected to begin in 2026 and operations planned for 2031.Roche’s Genentech also said it will invest nearly US$ 2 billion in a new bio-manufacturing facility in Holly Springs, North Carolina, to manufacture next-generation metabolic treatments, including obesity medicines. Access the Pipeline Prospector Dashboard for January 2026 Newsmakers (Free Excel)AI deals in Jan: Astra buys Modella AI; Sanofi ties up with Earendil; Lilly-Nimbus in obesity research dealArtificial intelligence is taking centerstage in dealmaking. AstraZeneca agreed to acquire Boston-based Modella AI (deal size not disclosed), integrating its foundation models and AI agents into oncology R&D to support clinical development and biomarker discovery.Similarly, Sanofi signed an AI-powered autoimmune and inflammatory disease collaboration worth up to US$ 2.56 billion with Earendil Labs, which will receive up to US$ 160 million in upfront and near-term payments. Sanofi will lead development and commercialization of bispecific candidates from the partnership.Lilly also signed a multi-year AI-driven obesity research and licensing agreement with Nimbus Therapeutics worth up to US$ 1.3 billion. Additionally, Lilly and Nvidia announced an expanded AI partnership, including a US$ 1 billion co‑innovation lab in the Bay Area (US) to integrate advanced computing and biology for drug discovery. This announcement was made at JPM26. Access the Pipeline Prospector Dashboard for January 2026 Newsmakers (Free Excel)Novo’s Wegovy pill makes blockbuster debut in US; Darzalex Faspro quadruplet wins FDA nodIn January, the pill version of Novo Nordisk’s Wegovy (semaglutide) made a stunning debut in the US. It was prescribed more than 18,000 times in the first full week after ‌its launch. Novo’s stock price went up by 14 percent during the month.Johnson & Johnson secured an approval from the US Food and Drug Administration (FDA) for Darzalex Faspro (daratumumab and hyaluronidase) as part of a four-drug regimen for newly diagnosed multiple myeloma patients ineligible for an autologous stem cell transplant. The combination includes Darzalex Faspro with Velcade (bortezomib), Revlimid (lenalidomide) and dexamethasone. The approval marks Darzalex Faspro’s 12th indication overall and its fifth in the newly diagnosed multiple myeloma setting.Darzalex (daratumumab) remains J&J’s largest growth driver, generating US$ 14.4 billion in 2025 sales. J&J (stock up 10 percent) projected its 2026 revenue to be in the range of about US$ 100 billion to US$ 101 billion.FDA also approved Zycubo (copper histidinate) from Fortress Biotech and Sentynl Therapeutics (a US-based biopharma owned by Zydus Lifesciences), to treat Menkes disease, making it the first FDA-approved therapy for the genetic disorder in the US.On the clinical front, Amgen said its experimental obesity drug MariTide (maridebart cafraglutide) helped patients maintain weight loss when administered at a lower dose or less frequently. Access the Pipeline Prospector Dashboard for January 2026 Newsmakers (Free Excel)AbbVie partners China-based RemeGen in US$ 5.6 bn deal; GSK to acquire RAPT TherapeuticsAbbVie partnered China-based RemeGen in a US$ 5.6 billion oncology deal to develop and commercialize RC148, an experimental therapy for multiple advanced solid tumors. AbbVie will gain rights outside Greater China, while RemeGen will receive US$ 650 million upfront and up to US$ 4.95 billion in milestones, along with double-digit royalties. Britain’s GSK said it will acquire US-based RAPT Therapeutics (stock up 69 percent) in a US$ 2.2 billion deal, gaining global rights to the experimental food allergy drug ozureprubart, excluding rights in mainland China, Macau, Taiwan and Hong Kong.Eli Lilly (stock down 3 percent) entered into a US$ 1.93 billion collaboration with US-based Repertoire Immune Medicines to develop tolerizing therapies (treatments that restore the immune system’s ability to recognize self-antigens) for autoimmune disease targets. Repertoire will receive US$ 85 million upfront and up to US$ 1.84 billion in milestones, while Lilly will take over clinical development and commercialization.Novartis added an Alzheimer’s program to its pipeline through a licensing and collaboration deal with SciNeuro Pharmaceuticals, paying US$ 165 million upfront and up to US$ 1.5 billion in milestones. Access the Pipeline Prospector Dashboard for January 2026 Newsmakers (Free Excel)Our viewThis year, several new medications, including treatments for weight loss, hypertension, smoking cessation and plaque psoriasis, are likely to receive FDA approvals. Moreover, existing medications — such as Dupixent (dupilumab) and Wegovy (semaglutide) — could see expanded indications. January has already set a dynamic tone for the year ahead. 

Impressions: 185

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-jan-2026-highlights-astra-cspc-sign-up-to-us-18-5-bn-obesity-deal-wegovy-s-pill-version-debuts-in-us

#PharmaFlow by PHARMACOMPASS
05 Feb 2026

NEWS #PharmaBuzz

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https://www.prnewswire.com/news-releases/darzalex-faspro-based-quadruplet-regimen-approved-in-the-us-for-newly-diagnosed-patients-with-multiple-myeloma-who-are-transplant-ineligible-302671736.html?tc=eml_cleartime

PR NEWSWIRE
28 Jan 2026

https://www.pharmiweb.com/press-release/2026-01-20/atopia-therapeutics-reports-preclinical-proof-of-concept-of-lead-compound-atp-r13-in-atopic-dermatitis-and-strengthens-patent-protection

PHARMIWEB
20 Jan 2026

https://www.indianpharmapost.com/news/shilpa-medicare-aims-for-us-approval-of-chemo-nausea-drug-18815

INDPHARMAPOST
09 Jan 2026

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216487

FDA
06 Jan 2026

https://www.globenewswire.com/news-release/2026/01/06/3213533/0/en/Sparrow-Pharmaceuticals-Announces-First-Patient-Enrolled-in-Phase-2b-Clinical-Trial-Evaluating-Clofutriben-for-Difficult-to-Control-Type-2-Diabetes.html

GLOBENEWSWIRE
06 Jan 2026

https://www.globenewswire.com/news-release/2025/12/07/3201148/0/en/Lyell-Immunopharma-Presents-New-Clinical-Data-from-Ongoing-Trial-of-Ronde-Cel-Showing-High-Rates-of-Durable-Complete-Responses-in-Patients-with-Large-B-cell-Lymphoma-at-the-67th-AS.html

GLOBENEWSWIRE
07 Dec 2025