The Federal Circuit's recent ruling that patents listed in the FDA's Orange Book must cover the active ingredient of a drug has sparked significant debate in the pharmaceutical industry. The court's ...

Teva sued Amneal for patent infringement under the Hatch-Waxman Act after receiving notice Amneal sought to sell a generic version of Teva’s ProAir HFA inhaler product. Teva’s ProAir HFA is a ...

In elderly patients with sufficient cognitive function, manual dexterity, and hand strength, the most influential factors in inhaler selection are cost reimbursement, device availability ...

Asthma inhalers are hand-held devices that ... MDIs can recognized by the abbreviation HFA (which stands for the propellant hydrofluoroalkane). These include Ventolin HFA, Proventil HFA, Proair HFA, ...

HFA-based metered-dose inhalers (MDIs ... You should finish it or run out by 30 days. Some inhaler devices, such as ProAir Digihaler, are Bluetooth linked to a companion mobile app, so it will alert ...

The appellate court order stems from a case brought by Teva against drugmaker Amneal Pharmaceuticals (NYSE: AMRX) after the latter sought Food and Drug Administration (FDA) approval to bring a generic ...

[23] The Federal Circuit noted that “the fact that the FDA approved Teva’s ProAir® HFA combination product as a drug does not make the inhaler’s device parts a drug. They are still devices ...

ProAir HFA inhaler from the Food and Drug Administration’s Orange Book. Amneal plans to market a generic version of the inhaler and had argued that Teva’s patents were incorrectly included on ...

U.S. District Judge Stanley Chesler agreed with Amneal in June, finding the patents only cover parts of an inhaler device and "do not claim or even mention" ProAir HFA's active ingredient.

After exposure to extreme environmental temperatures, an increase in propellant-leak rate was observed with Proventil HFA and Ventolin HFA MDIs, but little to no change was found in particle size ...

“In the United States, while 93% of Teva’s inhaler medicines are generic products with access at lower prices – particularly for insured ... salmeterol xinafoate maintenance inhaler) and ProAir® HFA ...

Teva Pharmaceuticals failed to convince a U.S. appeals court on Friday to reverse a decision that would remove patents related to its ProAir HFA inhaler from the U.S. Food and Drug Administration ...