Actavis Files ANDA for Generic Ambrisentan Tablets for PAH

Actavis Files ANDA for Generic Ambrisentan Tablets for PAH

actavisActavis recently confirmed that the company has filed an Abbreviated New Drug Application (ANDA) with the United States Food and Drug Administration (FDA) seeking approval to commercialize their formulation of Ambrisentan Tablets (5 and 10 mg). This drug is a generic version of Letairis® from Gilead Sciences, Inc. to address treatment for pulmonary arterial hypertension.

Royalty Pharma Collection Trust and Gilead Sciences, Inc. recently filed a lawsuit against Actavis in the United States District Court in the District of Delaware with the goal of preventing Actavis from marketing its product before the expiration of United States Patent number RE42,462. The lawsuit’s outcomes resulted in a delay of the agency’s approval of Actavis’ ANDA for up to thirty months beginning from the date the complainant received notice of the filing from Actavis or until a final resolution of the matter before the court — whichever occurs sooner — without prejudice of the other exclusivities.

Supported by newly available information, Actavis thinks this might be the first application of an ANDA for a generic version of Letairis®, and it should be approved to potentially offer 180 days of generic market exclusivity to the company.

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Actavis is a global pharmaceutical company whose headquarters are located in Dublin, Ireland. Actavis is committed to advancing, manufacturing and marketing innovative branded drugs, top generic medicines, and biologic products to address patients across the globe. The company is particularly focused on conditions involving the central nervous system, women’s health, medical aesthetics, eye care, gastroenterology, urology, and cardiovascular system. The company runs commercial operations in about 100 countries and works closely with healthcare providers, physicians and patients in order to deliver innovative treatments so that those around the world can live longer and healthier lives.

In related news, Actavis and AstraZeneca recently announced signing a new agreement assuring that AstraZeneca will acquire the rights to Actavis’ respiratory portfolio in both Canada and the United States for an upfront payment worth $600 million upon completion, followed by low single-digit royalties above a specific revenue threshold. After the transaction is completed, AstraZeneca will own the rights to two COPD treatments: long-acting muscarinic antagonist (LAMA) Tudorza Pressair (aclidinium bromide inhalation powder), and oral PDE4 inhibitor Daliresp® (roflumilast).

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