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On December 20, 2024, the Federal Circuit issued its ruling in Teva Branded Pharm. Prods. R&D, Inc. v. Amneal Pharms. of N.Y., LLC, No. 24-1936, interpreting the requirements for Orange Book patent listings in the Federal Food, Drug, and Cosmetic Act (FDCA).
The ruling marks a significant...

First interchangeable biosimilar exclusivity (FIE) is a market exclusivity period designated for the first biosimilar approved as interchangeable with a reference product. Created by the Biologics Price Competition and Innovation Act (BPCIA), the length of the FIE period has been a subject of...

In early May 2024, Google DeepMind launched AlphaFold 3, an advanced AI model capable of predicting the structures and interactions of biological molecules. The upgrade generates 3D models for proteins, DNA, and other molecular entities, aiding scientists in making groundbreaking new drug...

Artificial Intelligence (AI) is reshaping operations across various industries, including the pharmaceutical arena. Although AI-enabled drug discovery is still in its infancy, ongoing investor interest and technological advances suggest an increasingly pivotal role in developing new therapies in...

On June 20, FDA issued a draft guidance proposing to remove switching studies from the interchangeable biosimilar approval process.
The draft guidance eliminates the longstanding recommendation that biosimilar developers provide clinical data showing interchangeability with reference drug...

According to a recent Draft Guidance, FDA is considering eliminating written requests for pediatric exclusivity under the Best Pharmaceuticals for Children Act (BPCA) when the studies are already required under the Pediatric Research Equity Act (PREA).
If finalized, the Guidance would remove...

Growth in orphan drug sales is surpassing growth in the broader pharmaceuticals market. Analysts estimate that top-selling orphan drugs like Darzalex and Ultomiris will make up 20% of all prescription drug sales by 2026. With sales hitting $160.5 billion in 2021, estimates predict that the orphan...

On August 5, 2021, a Federal Circuit panel upheld a $235 million verdict against Teva Pharmaceuticals over induced infringement of GlaxoSmithKline's Coreg (carvedilol).
The precedent setting decision has generic applicants questioning what exactly constitutes induced infringement regarding...

On August 13, 2021, FDA announced it would accept comments on a proposal to treat pre-Hatch-Waxman abbreviated new drug applications, or PANDAs, as NDAs. Despite objections, the agency is apparently already implementing changes.
With the 1984 Hatch-Waxman Amendments, generic drugs are...