相关临床试验
20
10 进行中
药物批准
78
批准总数
监管机构
5
监管机构数
成立时间
N/A
进行中（未招募）
5
25.0%
已完成
7
35.0%
尚未招募
5
25.0%
招募中
3
15.0%
- Natco Pharma received tentative USFDA approval for generic Olaparib tablets (100 mg and 150 mg), deemed bioequivalent to AstraZeneca's Lynparza®. - Alembic Pharmaceuticals will distribute the product in the U.S. market while Natco handles manufacturing, with ongoing Para IV litigation. - Olaparib tablets generated estimated U.S. sales of approximately USD 1.4 billion over the 12 months ending March 2026, per IQVIA data. - This marks Alembic's 244th ANDA approval from the USFDA, comprising 224 final and 20 tentative approvals.
- The Indian Patent Office rejected AbbVie's patent applications for two blockbuster drugs, Rinvoq (upadacitinib) for immunology conditions and Maviret for Hepatitis C, citing lack of inventive step and abandonment respectively. - The Rinvoq patent rejection under Section 3(d) of the Indian Patent Act prevents "evergreening" of pharmaceutical patents, similar to the landmark Novartis Glivec case in 2013. - These decisions will enable affordable generic versions to enter the Indian market, benefiting millions of patients with rheumatoid arthritis, autoimmune diseases, and Hepatitis C. - AbbVie's failure to contest pre-grant oppositions for Maviret resulted in abandonment of the secondary patent application, preventing a five-year extension of patent monopoly.
- Breckenridge Pharmaceutical launched Everolimus Tablets 1mg, a generic version of Novartis' Zortress, completing their full strength portfolio of this immunosuppressant medication. - The mTOR inhibitor is indicated for preventing organ rejection in adult kidney and liver transplant patients and will be available through retail, mail order pharmacies, and clinics. - This launch follows Breckenridge's previous releases of lower strength everolimus tablets, with the company emphasizing affordable access to essential transplant medications. - The product was developed in collaboration with Natco Pharma Limited and became available starting October 30, 2025.
- The Indian Patent Office revoked Novartis' patent for Vymada (Entresto), a heart failure drug generating $7.8 billion in global sales, citing lack of novelty and inventive step. - The ruling removes legal barriers for domestic pharmaceutical companies including Natco, Torrent Pharma, MSN Labs, and Eris Lifesciences to market generic versions. - The decision invoked Section 3(d) of India's Patents Act, designed to prevent "evergreening" of patents, marking a rare application of this provision in recent years. - Industry experts expect increased competition to significantly reduce treatment costs for Indian patients with hypertension and heart failure.
- NATCO Pharma Limited received an Establishment Inspection Report (EIR) from the U.S. FDA for its Active Pharmaceutical Ingredient facility in Mekaguda, Hyderabad on July 24, 2025. - The FDA inspection conducted from June 9-13, 2025 resulted in one observation classified as "Voluntary Action Indicated" (VAI), which the company characterized as procedural in nature. - The successful resolution demonstrates NATCO's commitment to maintaining cGMP compliance and ensuring high-quality API manufacturing for global pharmaceutical supply chains.
