Sidvim LifeSciences Private Limited

  Contents Patent applications filed by Alkem Laboratories Limited General information Ensuring R&D investments deliver maximum potential: Notable ways to enhance clinical development strategy and design Top 5 pharma marketing trends in 2024 Intellectual Property Pharmacyclics Llc & Anr. vs Hetero Labs Limited & Ors- Ibrutinib case Patent applications filed by Alkem Laboratories Limited We follow patent applications filed by Indian companies and analyse their development strategies. This week we analysed patent portfolio of Alkem. We downloaded patent families filed by Alkem and mainly studied their PCT applications.  In last 5 years Alkem had filed over 12 PCT applications. Some of our observations are as below. Publication Number Title Publication Date Comments WO2023126973A1 Stable composition used for treatment of endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis, comprises elagolix, solubilizers and excipients 2023-07-06 Elagolix w

  Contents ANDA approvals in December 2023 General information "Genetic priority score" promises to revolutionize drug development Scientists hail new antibiotic that can kill drug-resistant bacteria Intellectual Property CAFC Affirmed PTAB Decision to Invalidate All Claims of United Therapeutics Patent US 10,716,793 (`793) ANDA approvals in December 2023 We follow ANDA approvals mainly Indian companies. In December 2023, there were about total 72 ANDA approvals and out of which 9 were tentative approvals. Lupin and Zydus sought approvals for 4 ANDAs each. Total 37 approvals for Indian ANDA fliers. Some of our observations are as below.  Active Ingredients Company Comments SILDENAFIL CITRATE GRANULES This approval is for oral suspension, 10 MG/ML. Sildenafil for oral suspension is indicated for the treatment of pulmonary arterial hypertension. The current annual US market for Sildenafil for oral suspension is approximately $43 million, according to MAT Sep 2023.