Sidvim LifeSciences Private Limited

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1.) Recent 505 (b) (2) filings 2.) Allergan Vs. Sandoz

December 06, 2025

Contents Recent 505 (b) (2) filings General information TQ Therapeutics GmbH Enters into Technology Access Agreement with Kytopen Delhi High Court refuses to restrain Dr Reddy's from manufacturing, exporting Ozempic like drug Intellectual Property Allergan Vs. Sandoz 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 . In November 2025, a tentative approval was granted for the Ruxolitinib NDA (#219660) for Apotex. Ruxolitinib tablets are marketed as ruxolitinib phosphate salt under the brand name Jakafi. We are trying to understand why Apotex filed an NDA instead of an ANDA. There is one new strength, 2 MG, but other str...

1.) Development activities of Neuland Laboratories Limited (NLL) 2.) Otsuka: Freeze-dried cake composition of Aripiprazole

November 30, 2025

Contents Development activities of Neuland Laboratories Limited (NLL) General information Amgen prevails over Sanofi at UPC Court of Appeal with Brinkhof and Bardehle CCRAS launches SIDDHI 2.0 to strengthen research-driven innovation in Ayurveda pharma sector Intellectual Property Otsuka: Freeze-dried cake composition of Aripiprazole Development activities of Neuland Laboratories Limited (NLL) We monitor the exports of many companies and then attempt to analyse their development activities. Some inferences that can be drawn from NLL's export data about its development capabilities are as follows. General information Amgen prevails over Sanofi at UPC Court of Appeal with Brinkhof and Bardehle Amgen's most important cholesterol-lowering patent EP 797 is valid after all, according to a landmark ruling by the UPC Court of Appeal yesterday. The decision allows Amgen to proceed with its infringement action against Sanofi and sets important precedents for future revocation...

1.) Recent P-IV filings (Maralixibat Chloride, Livmarli) and 2.) GSK vs Pfizer- A case related to mRNA vaccine technology.

November 22, 2025

Contents Recent P-IV filings General information Ken Paxton files lawsuit against drug companies accused of hiding information on Plavix Depo-Provera Litigation Now Includes Over 2,000 Brain Tumor Lawsuits Brought by Women Intellectual Property GSK vs Pfizer Recent P-IV filings We follow P-IV filings on the FDA website. The recent update was on 11 November 2025. ANDA with P-IV filed recently related to Maralixibat Chloride. A recent Paragraph IV (P-IV) certification filing related to Maralixibat Chloride, (Livmarli), an ileal bile acid transporter (IBAT) inhibitor, was first approved by the FDA in September 2021 for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS). Four ANDAs were filed for 9.5 MG, and three ANDAs were filed for 19 MG with P-IV certification. As per public domain information, one of the ANDA filers is Sandoz. The OB listed patents are as follows. Maralixibat is an old molecule. Maralixibat was reportedly first patented by...

Recent ANDA approvals and British-American Tobacco (Investments) Limited vs Swedish Match North Europe AB

November 15, 2025

Contents Recent ANDA approvals General information Tharimmune Receives Positive FDA Feedback for TH104 Prophylaxis Program Against Respiratory Depression from Fentanyl and Ultrapotent Opioids InterDigital accelerate battle against Amazon in Europe, Brazil and the US Intellectual Property British-American Tobacco (Investments) Limited vs Swedish Match North Europe AB Recent ANDA approvals We follow ANDA approvals. In October 2025, the USFDA issued a total of 69 ANDA approvals, of which 19 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 October were as follows. Some of our other comments about a few...

Recent 505 (b) (2) filings (October 2025) and Discovery process in US litigations: OptraSCAN, Inc. v. Morphle Labs

November 09, 2025

Contents Recent 505 (b) (2) filings General information Building Resilience in Pharma: Our Top 10 Questions from CPHI Frankfurt Biologics Market Surges Toward $680B as FDA Accelerates Approval Pathways Intellectual Property Discovery process in US litigations: OptraSCAN, Inc. v. Morphle Labs 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 October 2025, 505 (b) (2)/NDA approvals are as follows: General information Building Resilience in Pharma: Our Top 10 Questions from CPHI Frankfurt Exclusive interviews revealed that digital transformation, data integrity protocols, and a regionalized supply chain are cruci...