Sidvim LifeSciences Private Limited

Contents DMFs filed in July 2025 General information Xspray Pharma: FDA accepts New Drug Application for XS003 (nilotinib) for the treatment of CML – PDUFA date set for June 18, 2026 Novo Nordisk and D Young defend crucial patent for tablet form of semaglutide Intellectual Property Risdiplam : F. Hoffmann-La Roche AG vs Natco Pharma Limited, Delhi High Court DMFs filed in July 2025 The FDA publishes a list of DMF filings each quarter. The list for the third quarter was recently released. A total of 322 DMFs were filed during that period. Below is the list of companies that submitted more than three DMFs in the quarter. One can notice that there are many Chinese companies on the top DMF filing list. Some of the other observations of a few DMFs filed by Indian companies are as follows. General information Xspray Pharma: FDA accepts New Drug Application for XS003 (nilotinib) for the treatment of CML – PDUFA date set for June 18, 2026 XS003 is an improved formulation of nilotin...

Contents Recent ANDA approvals General information Thousands in UK sue Johnson & Johnson over talcum powder cancer risks HC refuses to bar AET Lab on drug for chemotherapy-induced nausea, vomiting Intellectual Property Astellas v. Ascent -Mirabegron Recent ANDA approvals We follow ANDA approvals. In September, the USFDA issued a total of 57 ANDA approvals, of which 13 were tentative. A tentative approval is a formal notification from the USFDA indicating that a generic drug application has met all scientific and regulatory requirements for safety, efficacy, and quality, but cannot be granted final marketing approval due to unexpired patents or market exclusivities held by the original brand-name drug. The companies that could seek more than two ANDA approvals (including tentative ones) in September were as follows. Some of our other comments about a few ANDA approvals sought by Indian companies are listed below. General information Thousands in UK sue Johnson & ...

Contents Recent 505 (b) (2) filings General information GLP-1 Litigation and the Road Ahead for Independent Pharmacies Pharmacy groups defend Iowa PBM law amid legal challenge Intellectual Property Delhi High Court case, Wow Momo Foods Private Limited vs. Wow Burger. Recent 505 (b) (2) filings We follow 505 (b) (2) approvals every month. Generally, 505(b)(2) NDAs pertain to changes in comparison to previously approved drugs, such as indication, active ingredient, fixed-combination, dosage form, route of administration, dosing regimen, strength, and formulation (not approvable under section 505(j)). For more details on 505(b)(2) FDA approvals, please visit this link . The details of September 2025, 505 (b) (2)/NDA approvals are as follows: General information GLP-1 Litigation and the Road Ahead for Independent Pharmacies The GLP-1 era has moved from innovation to enforcement. Independent pharmacies that once played a critical role in meeting patient demand during shortages ...

Contents Recent P-IV filings. General information How to realise therapeutic potential with the right excipients ARS Pharmaceuticals Sues AptarGroup Over Alleged Monopoly in Epinephrine Device Supply Intellectual Property Calcifediol Soft Capsules by FAES FARMA — An EPO decision Recent P-IV filings. We monitor ANDAs with P-IV certification filings on the USFDA website. The Significance of P-IV Filing: The first applicant (or multiple applicants on the first day) to submit an ANDA with a P-IV certification and successfully challenge the brand's patent is generally eligible for 180 days of generic market exclusivity. The USFDA updated the list on 01 September 2025, and there was one P-IV filing. Reference Listed Drug (RLD): The brand name drug for Finerenone is Kerendia, manufactured by Bayer.  Date of First P-IV Submission: A substantially complete ANDA with a Paragraph IV certification for Finerenone Tablets (10 mg and 20 mg) was first submitted on 09 July 2025. It was...