General Biotechnology

The Reformulation Playbook: How Pharma Uses 505(b)(2) to Lock In New Patents, Block Generics, and Reset Prices

Pharma’s “reformulation playbook” is getting a new lease on life—and 505(b)(2) is the engine.
For years, the industry narrative has been simple: reformulation is innovation. But if you look closely at how the 505(b)(2) pathway is being used, a differen…

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