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DATA COMPILATION #PharmaFlow

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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.  

Impressions: 4947

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

STOCK RECAP #PipelineProspector

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Pipeline Prospector October 2025: Novartis to buy Avidity for US$ 12 bn; FDA approves Bayer’s med to treat hot flashes
October was abuzz with dealmaking. Pharma majors such as Novartis, Novo Nordisk, and Bristol Myers Squibb (BMS) led the acquisition wave, targeting innovative platforms in rare muscle disorders, metabolic diseases, and next-generation cell therapy for autoimmune diseases. The US Food and Drug Administration (FDA) approved Bayer’s Lynkuet (elinzanetant) — the first-of-its-kind oral non-hormonal drug to treat moderate to severe hot flashes in menopausal women. The agency also expanded the indication for Teva Pharmaceuticals and Medincell’s schizophrenia drug received Uzedy (risperidone), allowing it to be used for the maintenance treatment of bipolar I disorder in adults.In clinical trials, companies such as Eli Lilly and AstraZeneca reported positive data, while Moderna and Alector announced late-stage trial setbacks.The pharma indices continued to march upwards. The Nasdaq Biotechnology Index (NBI) rose nine percent, climbing from 4,916.11 at the end of September to 5,366.46 in October, while the SPDR S&P Biotech ETF (XBI) gained 13 percent from 100.11 to 112.71. The S&P Biotechnology Select Industry Index (SPSIBI) also advanced 13 percent from 7,805.59 to 8,789.9. Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel) Novartis to acquire Avidity for US$ 12 bn; Novo in up to US$ 5.2 bn deal to buy Akero The month saw several big M&A deals. Novartis entered into an agreement to acquire Avidity Biosciences for about US$ 12 billion in cash, in a bid to bolster its portfolio of treatments for rare muscle disorders. In September too, Novartis had struck four deals valued at over US$ 14 billion.Novo Nordisk announced it will acquire Akero Therapeutics, a San Francisco-based clinical-stage biotech, in a deal valued at up to US$ 5.2 billion. The agreement includes an upfront payment of US$ 4.7 billion, with additional milestone payments contingent on FDA approval of Akero’s lead candidate, efruxifermin, by mid-2031. Efruxifermin is being developed as a treatment for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease.Bristol Myers Squibb announced the acquisition of privately-held biotech Orbital Therapeutics in a US$ 1.5 billion all-cash deal. Orbital is developing new generation, RNA-based medicines.France’s Ipsen announced the acquisition of ImCheck Therapeutics for up to €1 billion (approximately US$ 1.16 billion) to enhance its oncology pipeline. Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)  FDA approves Bayer’s non-hormonal drug to treat hot flashes in menopausal women; okays Teva’s Uzedy for bipolar I disorderOctober brought good news for menopausal women dealing with hot flashes. FDA approved Bayer’s Lynkuet (elinzanetant) — the first-of-its-kind oral non-hormonal drug to treat moderate to severe hot flashes in menopausal women.Teva Pharmaceuticals and Medincell received FDA’s approval for expanding the indication of Uzedy (risperidone). An injection of Uzedy can be administered once a month as a maintenance treatment of bipolar I disorder in adults. Uzedy was approved in 2023 for schizophrenia.FDA also expanded the approval of Novo Nordisk’s Rybelsus (semaglutide) for use in adults with type 2 diabetes to reduce the risk of major adverse cardiovascular events. Rybelsus, the first and only FDA-approved GLP-1 drug, was first approved in 2019.Meanwhile, Glaukos’ Epioxa (riboflavin 5'-phosphate) was cleared by the FDA for treating keratoconus, a rare, progressive eye disorder that thins and bulges the cornea. The non-surgical therapy offers an incision-free option for patients at risk of vision loss.FDA also approved Regeneron’s immunotherapy Libtayo (cemiplimab) to help prevent relapse in adults with high-risk cutaneous squamous cell carcinoma after surgery and radiation. Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)  Innovent, Takeda sign up to US$ 11.4 bn oncology deal; J&J to spin off its orthopedics businessInnovent Biologics has signed a deal worth up to US$ 11.4 billion with Takeda Pharmaceutical to co-develop two next-generation cancer therapies. The collaboration covers an antibody-drug conjugate (ADC) and a fusion protein, targeting a range of solid tumors, including lung, colorectal, gastric, and pancreatic cancers. Takeda will hold commercialization rights for both therapies outside the US and Greater China, while the companies will jointly develop and commercialize one of the drugs, IBI363, in the US.Novo Nordisk has signed a deal worth up to US$ 2.1 billion with Omeros Corporation for rights to develop and commercialize zaltenibart (OMS906), Omeros’ experimental drug for rare blood and kidney disorders. The deal strengthens Novo Nordisk’s rare disease portfolio.Massachusetts-based Zenas BioPharma entered into a licensing agreement worth over US$ 2 billion with China’s InnoCare Pharma for orelabrutinib, an oral treatment for multiple sclerosis (a chronic disease in which the immune system attacks the brain and spinal cord).  And Johnson & Johnson announced it will spin off its orthopedics business, DePuy Synthes, into a separate company within 18 to 24 months.Besides these deals, the month saw several capacity expansions. Merck broke ground on a US$ 3 billion plant at its Elkton, Virginia campus, as part of a wider US$ 70 billion commitment to expand manufacturing, R&D, and capital projects in the US. Similarly, AstraZeneca announced a US$ 4.5 billion investment to build a state-of-the-art manufacturing facility in Virginia, as part of its US$ 50 billion investment plan for the US.Eli Lilly said it plans to invest over US$ 1 billion in India over the next few years to boost drug manufacturing and supply through partnerships with local producers. Lilly will also invest over US$ 1.2 billion to expand its manufacturing site in Puerto Rico. Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)  Lilly’s orforglipron scores trial wins in diabetes; Astra-Daiichi breast cancer med shows promise Eli Lilly’s oral GLP-1 drug orforglipron scored two major phase 3 wins in diabetes, outperforming AstraZeneca’s Farxiga (dapagliflozin) and a placebo in separate studies.In a phase 3 trial, AstraZeneca’s experimental drug baxdrostat significantly lowered blood pressure in patients with treatment-resistant hypertension. AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan), an antibody-drug conjugate, significantly improved survival in patients with metastatic triple-negative breast cancer compared to chemotherapy in a phase 3 clinical trial.In trial failures, Moderna said it will stop developing its experimental vaccine, mRNA-1647, designed to prevent cytomegalovirus (CMV), a virus that can cause birth defects, after it failed to meet the main goal in a phase 3 trial. Similarly, Alector stopped developing its GSK-partnered experimental dementia drug, latozinemab, after it failed to help patients in a major phase 3 trial. Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)  Our viewWith drugs like Bayer’s Lynkuet bagging approval, we see both innovation and competition steering the pharma industry into 2026. Novo Nordisk’s US$ 8.5 billion bid to acquire US-based obesity biotech Metsera, surpassing Pfizer’s US$ 7.3 billion offer, underscores where much of the excitement lies — the rapidly expanding US$150 billion weight loss drugs market. The pharmaceutical industry seems to be on a high-speed treadmill, with no scope for sluggishness. Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)  

Impressions: 3081

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-october-2025-novartis-to-buy-avidity-for-us-12-bn-fda-approves-bayer-s-med-to-treat-hot-flashes

#PharmaFlow by PHARMACOMPASS
06 Nov 2025

NEWS #PharmaBuzz

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https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219910

FDA
17 Oct 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219910

FDA
17 Oct 2025

https://www.pharmacompass.com/pdf/news/premier-pharmacy-labs-issues-voluntary-nationwide-recall-of-all-unexpired-sterile-drug-product-lots-due-to-lack-of-sterility-assurance-1560923636.pdf

FDA
18 Jun 2019

https://www.pharmacompass.com/pdf/news/avedro-incs-photrexa-viscous-riboflavin-5-phosphate-dextran-approved-in-us-treatment-of-keratoconus-1461067032.pdf

FDA
15 Apr 2016