SCIENTURE Announces Issuance of Orange Book-Listable Patent Covering REZENOPY™, the Highest Dosage Naloxone HCl Nasal Spray Approved by the FDA for Life-Saving Opioid ...

U.S. Naloxone Market: ~$154 million in annual sales and 9.3 million units annually COMMACK, NY, Jan. 14, 2026 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX), a holding company for ...
Morningstar

SCIENTURE announces FDA Orange Book Patent Listing for ArbliTM, (losartanpotassium) Oral Suspension, 10mg/mL.

TAMPA, FL, May 19, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to ...
JD Supra

FTC disputes new slate of Orange Book patents for weight loss, diabetes, asthma, and COPD drugs

On April 30, 2024, the Federal Trade Commission (FTC) announced that it sent a new set of warning letters to ten pharmaceutical companies. The letters inform the companies that the FTC has notified ...
Seeking Alpha

Phathom Pharmaceuticals Submits Citizen Petition to FDA Seeking Correction of Orange Book Listings for VOQUEZNA® (vonoprazan) Tablets

Phathom believes applicable law mandates a 10-year NCE exclusivity period (from date of first approval of drug containing vonoprazan) benefitting all vonoprazan-based products, with exclusivity until ...
JD Supra

FTC Weighs In on Orange Book Listing of Drug-Device Patents

The Situation: On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., ...

EXCLUSIVE: Penny Stock Scienture's Partner Secures US Patent For Highest Dosage Naloxone Spray For Emergency Opioid Overdose Treatment

The United States Patent and Trademark Office has issued U.S. Patent No. 12,514,854 B2, an Orange Book-listable patent ...
IPWatchdog

Expansion to FTC’s Orange Book Campaign Leads to Calls for More Clarity from Pharmaceutical Industry

“The FTC acts as if the agency is being perfectly clear on what it’s subjecting companies to, but there’s never been a conversation around what it means for a patent to claim a drug product.” – Hans ...
IPWatchdog

Amneal, Aided by FTC, Succeeds in Getting Teva Patents Removed from Orange Book

“There is no dispute that the Inhaler Patents contain no claim for the active ingredient at issue, albuterol sulfate. Amneal contends that the Inhaler Patents do not meet the requirement that they ...
Morningstar

FDA Orange Book Lists New U.S. Patent for SOLOSEC, Evofem Biosciences' "One and Done" Oral Treatment for Bacterial Vaginosis and Trichomoniasis

SAN DIEGO, Aug. 19, 2025 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCID: EVFM) today announced that a newly-issued U.S. patent which covers SOLOSEC® (secnidazole) 2 g oral granules and one of its ...
csis.org

RAI Explainer: Generic Drugs, Property Rights, and the Orange Book

To advance policies that secure the future of a leading U.S. innovative industry, it is important in this instance to gain a deeper understanding of what generic drugs are, what the FTC is challenging ...