Sidvim LifeSciences Private Limited

  Contents Competitive Generic Therapy (CGT) approvals General information CytoSorbents Files Appeal with U.S. FDA for Supervisory Review of its De Novo Request for DrugSorb™-ATR Enlarged Board of Appeal harmonises EPO and UPC legislation 6 Intellectual Property AbbVie Biotherapeutics Inc. & Anr. vs Assistant Controller Of Patents- (Telisotuzumab vedotin) 7 Competitive Generic Therapy (CGT) approvals We follow CGT approvals. CGT designation: The Office of Generic Drugs provides a public list of all approved abbreviated new drug applications (ANDAs) for drug products with a Competitive Generic Therapy (CGT) designation and indicates which ANDAs on this list cover drug products eligible for CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act, of 180 days. This list is updated bi-weekly with new ANDA approvals where at least one of the drug products, such as one of the strengths in the approved application, received a CGT designation. Eligible for CGT Exc...

Contents P-IV filings in the recent past General information Lisata collaborates with GATC Health on drug development China proposes shorter clinical trial reviews in efforts to accelerate drug development Intellectual Property LG Chem Vs Evonik Operations GmbH P-IV filings in the recent past We follow P-IV filings by generic companies. The FDA published the list on June 9, 2025, and according to the information, a new ANDA was filed on April 22, 2025. Honour Labs and MSN filed DMFs in 2021 for remdesivir, and MSN may have submitted an ANDA on the NCE-1 date. Alternatively, it is possible that the ANDA filer utilised one of these DMFs in its ANDA submissions. Remdesivir, marketed as Veklury, received FDA approval for treating COVID-19 in adults and certain pediatric patients requiring hospitalisation. It was the first COVID-19 treatment to receive full FDA approval. This product was a top seller for Gilead during the pandemic; however, remdesivir sales are not expected to ...

Contents ANDA approvals in May 2025 General information FDA Action Update, May 2025: Approval, Clearance, and Authorisation Court of Appeal implements CJEU ruling in Janssen’s dispute with INPI Intellectual Property FDA Decision on Voquezna Exclusivity: ANDA approvals in May 2025 We follow ANDA approvals every month. There were about 98 approvals in May, 27 of which were tentative approvals. The companies whose two or more ANDAs were approved in May 2025 are listed below. The comments regarding the few ANDA approvals of Indian companies are as follows. General information FDA Action Update, May 2025: Approval, Clearance, and Authorisation ZEISS Medical’s INTRABEAM 700 received FDA clearance for intraoperative radiation therapy, enhancing precision and workflow efficiency in neuro-oncology and breast cancer treatments. Efgartigimod's pre-filled syringe approval offers patients with generalized myasthenia gravis and CIDP greater convenience and flexibility for in-home adm...

  Contents Recent 505 (b) (2) approvals General information Beijing IP Court Releases 2024 Annual Cases Hawaiʻi Secures $700 Million Settlement In Pharmaceutical Lawsuit Intellectual Property Dapagliflozin formulation patent decision by the Boards of Appeal at the EPO Recent 505 (b) (2) approvals 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)). More details on 505(b)(2) FDA approvals can be found here.  The details of May 2025, 505 (b) (2)/NDA  approvals are as follows: General information Beijing IP Court Releases 2024 Annual Cases On April 30, 2025, the Beijing IP Court (BIPC) released their list of 2024 annual cases including 7 IP-related cases and 1 antitrust case. The Court explained that the cases...