Sidvim LifeSciences Private Limited

Content NCE approval- Atrasentan General information The FDA (Food and Drug Administration) Drug Approval Process Training Course: Procedures for Submission of INDs, NDAs, ANDAs and 505(b)(2) (ONLINE EVENT: June 11-12, 2025) - ResearchAndMarkets.com No damages for Glenmark in battle over Mundipharma’s Targin Intellectual Property Semaglutide case: With the revocation of the composition patent, a generic launch in Europe could be possible earlier. NCE approval- Atrasentan   We monitor NCE approvals for small molecules. One approval from the FDA in April 2025 is for the small-molecule atrasentan.   Atrasentan, sold under the brand name Vanrafia, is a medication used to reduce proteinuria. Proteinuria, also known as albuminuria, refers to the presence of excessive protein, mainly albumin, in the urine. This condition typically indicates that the kidneys' filtering mechanisms (glomeruli) are not functioning correctly, allowing more protein to leak into the urine. Jeffe...

Contents Recent ANDA approvals General information Regeneron secures USD 400 million damages in drug competition suit AI/ML Innovations Seeks FDA Approval for MaxYield Signal Enhancement Intellectual Property Société des Produits Nestlé S.A. (Nestle) Vs N.V. Nutricia (Nutrica) Recent ANDA approvals We monitor ANDA approvals on a monthly basis.  There are approximately 70 ANDA approvals and 8 tentative approvals for April 2025.  The ANDA approvals sought by the different companies in April 2025 are listed below. About 60% of ANDA approvals go to Indian companies, with Aurobindo and MSN leading the list. Below are some of our product-specific observations. General information Regeneron secures USD 400 million damages in drug competition suit The verdict, handed down in the US District Court for the District of Delaware on 15 May, will see Amgen pay out a hefty penalty amounting to over USD 405 million in damages for its violations of the Clayton Antitrust Act, the Sh...

Contents Recent 505 (b) (2) approvals General information Gucci does not infringe Agfa leather printing patent Navigating The GLP-1 Litigation Landscape Intellectual Property GENERICS (U.K.) LIMITED v. ASTRAZENECA AB Recent 505 (b) (2) approvals We track 505 (b) (2) approvals.  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)). More details on 505(b)(2) FDA approvals can be found here .  The details of April 2025, 505 (b) (2)/NDA  approvals are as follows: General information Gucci does not infringe Agfa leather printing patent Gucci has not infringed Agfa's patent for a technique used in printing on leather, the UPC's local division Hamburg has ruled. However, the court found the patent to be legally valid. The decision provides detailed analysis o...