The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book, is its catalog of all approved chemical products. The two agencies said Sept. 14 that ...

Unlike technical standards such as 5G, as to which tens of thousands of patents held by a hundred or more companies have been declared as essential, the approved drug products in the Orange Book ...

The Approved Drug Products with Therapeutic Equivalence Evaluations is the published list of FDA-approved drugs deemed both safe and effective. It is more commonly called the Orange Book, a ...

In warning letters to 10 pharmaceutical companies, the FTC disputes the accuracy or relevance of the patent listings across 20 brand name products, as listed in the FDA's "Approved Drug Products ...

Phexxi is currently protected by four patents, each of which are listed in the FDA's publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the 'Orange Book.' ...

These improvements result in patents, which may be valid improvements or inappropriately applied to the drug. Either way, these patents are required to be filed in the Approved Drug Products with ...

Biofrontera received patent approval for the revised formulation of Ameluz® in April 2025, extending patent protection through to December 2043.The Orange Book is published by the U.S. Food and ...

FLORHAM PARK, N.J., June 16, 2025 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on developing and commercializing novel treatments for ...

This would involve leveraging existing safety and efficacy data from completed MDMA trials to bypass any listing in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations ...

--Biofrontera Inc., a biopharmaceutical company focused on the development and commercialization of photodynamic therapy, today announced the inclusion of the patent for its propylene glycol-free ...