News & Analysis as of

Prescription Drugs › Product Exclusivity

Proskauer - Life Sciences

In the Orphan Drug Approval Race, Winner Takes All? Ramifications of Catalyst Pharms. v. Becerra

Proskauer - Life Sciences on

How is orphan drug exclusivity affected when the FDA-approved use for an orphan drug is arguably narrower than the treatment of the rare disease it was designated for? By way of background, a sponsor can obtain orphan drug...more

Hogan Lovells

Biden signs bill limiting new drug exclusivity awards to innovations in active moiety

Hogan Lovells on

On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and promoting biosimilars. ...more

Troutman Pepper

Clinical Diagnosis of FDA's Clinical Investigation Exclusivity Standard? Unreasonable

Troutman Pepper on

For drug innovators, particularly those focusing on repurposing drugs for new indications and developing drugs that are not considered new chemical entities, understanding the scope of the clinical investigation exclusivity...more

Hogan Lovells

FDA’s Bendeka decision reverses approvals of Treanda generics

Hogan Lovells on

Wednesday, FDA released a letter stating how the agency intends to implement the scope of orphan drug exclusivity awarded to Eagle Pharmaceuticals’ Bendeka (bendamustine HCl) by the D.C. Circuit Court in Eagle...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Regulatory changes in Europe

Hogan Lovells on

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more

Hogan Lovells

FDA proposes new ways for prescription drugs to become available over-the-counter

Hogan Lovells on

On Tuesday, FDA’s Center for Drug Evaluation and Research (CDER) announced a draft guidance titled “Innovative Approaches for Nonprescription Drug Products” that could aid drug manufacturers who want to sell, without a...more

Troutman Pepper

Deuterated Drugs Are New Chemical Entities

Troutman Pepper on

FDA recently awarded new chemical entity (NCE) exclusivity to Austedo™ (deutetrabenazine). The Austedo approval is notable for two reasons: One, it is the first deuterated drug (i.e., a drug containing the stable isotope —...more

Troutman Pepper

FDA Is Evolving on Qualifications for 'New Chemical Entity'

Troutman Pepper on

The prior approval of a drug containing an active ingredient of the innovator drug is not necessarily a death knell for NCE exclusivity. Originally published in the Intellectual Property and Life Sciences sections of...more

The Volkov Law Group

Super Moon Harkens Low Tide for Hatch-Waxman Patent Disputes

The Volkov Law Group on

This week, the U.S. Supreme Court denied a petition for writ of certiorari in a case that will give pharmaceutical companies pause when considering whether to settle patent challenges under Hatch-Waxman. The Supreme Court’s...more

BakerHostetler

FDA Clarifies Orphan Drug Exclusivity Policy Following Court Defeat

BakerHostetler on

On the heels of a loss in federal court last fall, the FDA recently announced a clarification of its policy concerning orphan drug exclusivity. In short, despite a court ruling requiring the FDA to grant orphan drug...more

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