Product has patent protection through 2044 - - Expected to be listed in the U.S. Food and Drug Administration’s (FDA) Orange ...

In an attempt to curb inaccurate patent listings in the Food and Drug Administration’s “Orange Book,” a list of drugs the FDA has deemed safe and effective, the Federal Trade Commission has ...

Eton Pharmaceuticals (ETON) announced that the United States Patent and Trademark Office has granted the company U.S. Patent No. 12,214,010, ...

with the U.S. Food and Drug Administration (FDA). The petition formally requests correction of the Orange Book listings for VOQUEZNA (vonoprazan) 10 mg and 20 mg tablets to accurately reflect the ...

Teva insisted panel’s narrow interpretation of ‘claims the drug’ will have a seismic effect on the Orange Book | Stay granted while en banc rehearing is under question | Decision could reshape patent ...

The US Court of Appeals for the Federal Circuit affirmed a district court’s delisting of patents from the Orange Book because the patent claims did not “claim the drug that was approved” or ...

Leerink Partners analyst Faisal Khurshid has reiterated their bullish stance on GERN stock, giving a Buy rating yesterday.Invest with ...

In the Notice Letter in January 2023, Teva stated that it intended to market a generic version of Firdapse before the expiration of multiple of Catalyst’s patents listed in the FDA Orange Book.

PHYRAGO™ is protected by several issued patents, including those listed in the FDA's Approved Drugs and Therapeutic Equivalents publication (the "Orange Book") that expire January 22, 2041. The ...