Please Wait
Applying Filters...
Menu
Xls

Digital Content read-more

Create Content with PharmaCompass, ask us

DATA COMPILATION #PharmaFlow

read-more
read-more
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: 3350

https://www.pharmacompass.com/radio-compass-blog/fda-s-december-2025-opoe-list-features-784-prescription-drugs-73-otc-drugs

#PharmaFlow by PHARMACOMPASS
22 Jan 2026

WEEKLY NEWS RECAP #Phispers

read-more
read-more
Merck buys Verona for US$ 10 bn, gains its COPD med; Summit, Astra reportedly in talks for US$ 15 bn cancer drug deal
The world of pharmaceuticals continued to witness large deals. Merck announced a US$ 10 billion acquisition of Verona Pharma, gaining access to a US-approved inhaled chronic obstructive pulmonary disease (COPD) drug, Ohtuvayre.  Summit Therapeutics and AstraZeneca are reportedly negotiating a licensing deal worth up to US$ 15 billion for the former’s promising bispecific lung cancer drug. And Chugai Pharmaceutical has struck a potential US$ 1 billion collaboration with AI-driven biotech Gero to discover new therapies for age-related diseases.Dizal Pharmaceutical received accelerated approval from the US Food and Drug Administration (FDA) for Zegfrovy, the first pill that targets a rare and tough-to-treat mutation in lung cancer (known as EGFR exon 20 insertion mutations), giving new hope to patients.KalVista Pharmaceuticals won FDA approval for Ekterly, the first oral, on-demand treatment for hereditary angioedema, offering patients a convenient, fast-acting alternative to injectable therapies.After threatening to impose tariffs on imported drugs back in February, US President Donald Trump is now giving drugmakers over a year to “get their act together”. Post that, imported drugs could face 200 percent taxes, he said.Novartis faced setback as its blockbuster Cosentyx failed a phase 3 trial in giant cell arteritis. However, the Swiss drugmaker notched a regulatory win in its homeland with the approval of Coartem Baby, the first antimalarial therapy specifically designed for newborns. And Taiho Pharmaceutical’s experimental treatment for Duchenne muscular dystrophy (DMD) fell short in a late-stage trial.Merck set to acquire Verona for US$ 10 bn, to gain its FDA-approved COPD drugAmerican pharmaceutical giant Merck is set to acquire London‑based Verona Pharma for approximately US$ 10 billion. Verona’s flagship product, Ohtuvayre (ensifentrine), an FDA-approved, inhalable, non-steroid maintenance treatment for COPD, generated over 96 percent of the company’s revenue (US$ 76 million) in the first quarter of this year. Analysts estimate it could reach peak annual sales of nearly US$ 4 billion by the mid‑2030s.The acquisition aligns with Merck’s strategy to diversify ahead of the 2028 patent expiration of its cancer blockbuster, Keytruda (pembrolizumab), which earned nearly US$ 30 billion in 2024. This will be Merck’s largest acquisition since its US$ 10.8 billion Prometheus Biosciences deal in 2023.Astra reportedly in talks for US$ 15 bn licensing deal with Summit for its cancer drugSummit Therapeutics and AstraZeneca are reportedly in discussions for a licensing agreement concerning ivonescimab, an experimental lung cancer drug, potentially valued at up to US$ 15 billion. The deal structure under consideration includes an upfront payment of several billion dollars to Summit, with additional milestone-based payments contingent upon regulatory approvals, commercialization, and sales targets.Meanwhile, Japanese drugmaker JCR Pharmaceuticals has entered into a license agreement with AstraZeneca’s rare disease unit Alexion for JCR’s adeno-associated virus (AAV) capsids. Under the terms of the agreement, Alexion may use the licensed capsids in up to five of Alexion's genomic medicines programs. The deal is potentially worth up to US$ 825 million.Dizal’s oral therapy okayed for hard-to-treat lung cancer: FDA has granted accelerated approval to Zegfrovy (sunvozertinib), developed by Dizal Pharmaceutical, for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. This approval is specifically for patients whose disease has progressed on or after platinum-based chemotherapy. Zegfrovy is the only FDA-approved targeted oral therapy for NSCLC patients with EGFR exon 20 insertion mutations.FDA okays KalVista’s oral drug for fatal swelling disorder after missing target dateKalVista Pharmaceuticals has secured FDA approval for Ekterly (sebetralstat), marking the first-ever oral, on‑demand treatment for hereditary angioedema (HAE), a rare and potentially fatal swelling disorder. The agency’s green light followed a month‑long review delay, attributed to “heavy workloads and limited resources” at the FDA. Ekterly offers a substantial improvement over bulky injectables, with analysts describing it as transformative for HAE care.Label update for Lilly’s Kinsula: FDA has approved a label update for Eli Lilly’s Kisunla (donanemab) to allow a more gradual dosing of this Alzheimer’s drug, thereby lowering the risk of a potentially dangerous type of brain swelling. Kisunla, given as a monthly infusion, was approved by the FDA in July 2024 for adults with early-stage Alzheimer’s disease.Chugai inks deal with AI-driven biotech Gero for age-related disease targetsRoche‑backed Chugai Pharmaceutical and Singapore‑based AI‑driven biotech Gero have launched a joint research and licensing agreement targeting age‑related diseases in a deal valued at up to US$ 1 billion. The partnership harnesses Gero’s machine learning platform — trained on large-scale human datasets — to uncover novel therapeutic targets. Chugai will provide an undisclosed upfront payment followed by up to US$ 250 million in milestone payments tied to development and sales achievements.Trump hints at 200 percent tariffs on imported drugs after 18 monthsAfter threatening to impose tariffs on imported drugs back in February, the US President Donald Trump is now open to giving drugmakers some time to “get their act together”.  Post that, imported pharma products could face 200 percent taxes. “We’re going to give people about a year, a year and a half to come in and, after that, they’re going to be tariffed…they’re going to be tariffed at a very, very high rate, like 200 percent,” Trump warned. Novartis’ blockbuster antibody fails late-stage trial for artery diseaseNovartis’ blockbuster drug Cosentyx (secukinumab) has failed to meet the primary endpoint in its phase 3 trial for treating giant cell arteritis (GCA), a serious inflammatory condition affecting arteries primarily in individuals over the age of 50. The trial did not demonstrate a statistically significant improvement in achieving sustained remission at week 52 for patients with newly diagnosed or relapsing GCA when compared to placebo.Swissmedic okays antimalarial med for newborns: Switzerland’s medical regulator, Swissmedic, has granted approval to Coartem Baby (artemether-lumefantrine), also known as Riamet Baby, making it the first antimalarial therapy designed specifically for infants weighing between 2 kg and 5 kg. The therapy has been developed by Novartis and Medicines for Malaria Venture.Taiho’s DMD candidate fails in phase 3 trial: Taiho Pharmaceutical’s investigational therapy for Duchenne muscular dystrophy (DMD), known as TAS-205 or pizuglanstat, did not meet its primary endpoint in a late-stage trial conducted in Japan. The study aimed to assess the efficacy of TAS-205 in improving motor function.  

Impressions: 995

https://www.pharmacompass.com/radio-compass-phisper/merck-buys-verona-for-us-10-bn-gains-its-copd-med-summit-astra-reportedly-in-talks-for-us-15-bn-cancer-drug-deal

#Phispers by PHARMACOMPASS
10 Jul 2025

NEWS #PharmaBuzz

read-more
read-more

https://www.globenewswire.com/news-release/2026/04/24/3280516/0/en/novartis-malaria-treatment-coartem-baby-receives-who-prequalification-paving-way-for-greater-access-for-newborns-and-young-infants.html

GLOBENEWSWIRE
24 Apr 2026

https://www.fiercebiotech.com/biotech/novartis-resistance-busting-malaria-drug-ganlum-hits-phase-3-goal

FIERCE BIOTECH
13 Nov 2025

https://www.reuters.com/business/healthcare-pharmaceuticals/novartis-gets-approval-first-malaria-drug-babies-children-2025-07-08/

REUTERS
08 Jul 2025

https://www.europeanpharmaceuticalreview.com/news/163477/ganaplacide-lumefantrine-combination-a-potential-new-malaria-treatment/

Anna Begley EPR
30 Sep 2021
New Novartis drug takes aim at tough-to-treat malaria
New Novartis drug takes aim at tough-to-treat malaria

21 Aug 2017

// Ben Hirschler REUTERS

http://www.reuters.com/article/us-novartis-malaria-idUSKCN1B10KN

Ben Hirschler REUTERS
21 Aug 2017

http://economictimes.indiatimes.com/industry/healthcare/biotech/pharmaceuticals/nutraplus-starts-production-of-lumefantrine-at-tarapur-plant/articleshow/50625575.cms

ECONOMIC TIMES
18 Jan 2015