[1] The warning letters sent to the pharmaceutical companies are part of the FTC’s new policy regarding listing of patents in the FDA’s “Approved Drug Products with Therapeutic Equivalence Evaluations ...

Innovator companies should expect Orange Book patent listing challenges to emerge as an additional and simpler tool for ...

The investigation has been prompted by Teva’s refusal to take down about two dozen patents for its asthma and chronic obstructive pulmonary disorder (COPD) inhalers, according to a Washington Post ...

Teva’s asthma and COPD patents listed in the FDA’s Orange Book are under scrutiny and the company has until 24 July to adhere ...

According to "The Washington Post", the FTC claims that drug companies, among them Teva, made slight changes to their ...

These patents are listed in FDA's publication entitled Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. An NDA must be supported by studies ...

If a drug product is listed as discontinued in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the "Orange Book"), the manufacturer will also need to ask FDA if the drug ...

Dayvigo (lemborexant) is a brand-name oral tablet that’s prescribed for insomnia in adults. The cost of the drug with and without insurance can depend on several factors, such as whether Dayvigo ...

Diclofenac is a generic drug prescribed for conditions including arthritis in adults. It’s available as the brand-name drugs Zipsor, Cambia, and others. The cost of diclofenac with and without ...

We include products we think are useful for our readers. If you buy through links on this page, we may earn a small commission. Here’s our process. Mounjaro (tirzepatide) is a prescription drug ...

which is formally known as a compendium for the “Approved Drug Products with Therapeutic Equivalence Evaluations.” The Orange Book includes a list of safe and effective drug products that have ...