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Competitive Effects of Overlapping Drug Exclusivities

Competitive Effects of Overlapping Drug Exclusivities

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...

What GSK v. Teva Means for ANDA Skinny Labels

What GSK v. Teva Means for ANDA Skinny Labels

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...

FDA Proposes Treating PANDAs Like Full NDAs

FDA Proposes Treating PANDAs Like Full NDAs

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...


Full Rx-to-OTC Switch Are the Same Listing: No 180-day Exclusivity

Full Rx-to-OTC Switch Are the Same Listing: No 180-day Exclusivity

Over the past few years, FDA has lobbied to tighten (or even eliminate) the 180-day exclusivity period currently granted to the first generic drug applicant that submits an ANDA seeking FDA approval for a generic based on a listed drug product.
This exclusivity period provides an incentive...


The Enduring Role of Orphan Drug Exclusivity for Biologics

The Enduring Role of Orphan Drug Exclusivity for Biologics

From Humira and Rituxan to Herceptin and Enbrel, biologics continue to succeed in tackling numerous, challenging diseases and conditions. Many new biologics receive Orphan Drug designation for treating rare diseases, meaning sponsors get 12 years of Reference Product Exclusivity and seven years of...

FDA Extends its Rare Pediatric Disease PRV Program 

FDA Extends its Rare Pediatric Disease PRV Program 

On December 27, 2020, FDA extended the Rare Pediatric Disease Priority Review Voucher Program as part of the Coronavirus Response and Relief Supplemental Consolidated Appropriations Act of 2021.
Originally set to expire in October 2020, renewal of the Rare Pediatric Disease Priority Review...