December 2024

1. Executive Summary and Key Takeaways The FDA’s Product-Specific Guidance (PSG) program is now the most consequential publicly available dataset […]

The complete 2025 playbook for generic drug development strategy: Paragraph IV mechanics, complex generics IP moats, biosimilar development roadmaps, IRA

The global pharmaceutical landscape is undergoing a tectonic shift, and at its epicenter lies India. Long celebrated as the “Pharmacy

Amgen’s Amjevita became the first U.S. Humira biosimilar on January 31, 2023. Within twelve months, eleven additional adalimumab biosimilars had

The U.S. generic drug market generates roughly $120 billion in annual revenue and absorbs more than 90% of all dispensed

The traditional patent bargain—a 20-year monopoly in exchange for public disclosure—has transitioned into a sophisticated system of legal layering. In

How to attack weak patents, fortify your portfolio, and turn every validity challenge into a competitive lever — across the

The moment a brand-name pharmaceutical company files a patent, a clock starts. Somewhere else in the world—often in Ahmedabad, Mumbai,

A deep-dive reference for pharma IP strategists, ANDA portfolio managers, formulation leads, and institutional investors tracking the generic drug sector.