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11 August 2020AmericasRory O'Neill

Teva sues Cipla over generic asthma inhalers

Israeli drug manufacturer  Teva Pharmaceuticals is suing India-based Cipla to block the launch of generic  Qvar (beclomethasone dipropionate) asthma inhalers.

In a  complaint filed Friday, August 7 at the US District Court for the District of New Jersey, Teva claims that an abbreviated new drug application (ANDA) filed by  Cipla violates six patents.

Cipla informed Teva in June that it intended to seek authorisation from the US Food and Drug Administration to manufacture and commercialise generic Qvar inhalers.

According to Teva, Cipla made an offer of conditional access (OCA) to its ANDA “subject to various unreasonably restrictive conditions”.

Teva says that Cipla has refused to “provide the materials necessary to evaluate its ANDA products for infringement”.

“Teva’s counsel also expressed concern that Cipla would not be able to provide necessary product samples in a timely fashion, and requested a date certain by which such samples could be made available,” the complaint said.

The Israeli company said counsel for Cipla did not respond to its correspondence inviting them to engage in further discussions on the terms of the OCA.

Cipla’s June notice letter asserted that the manufacture and sale of the ANDA products would not infringe any of the six patents-in-suit.

But this letter did “not provide information regarding Cipla’s ANDA Products sufficient to evaluate Cipla’s assertions of noninfringement,” Teva claimed.

Teva is seeking a declaration of infringement, and an award of damages and attorneys’ fees. WIPR has contacted Cipla for comment in response to Teva’s allegations.

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3 June 2020   Israeli generic drugmaker Teva Pharmaceuticals must face infringement claims related to an asthma inhaler, an English judge has ruled.
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8 March 2022   Mumbai-based pharma company Cipla has filed a lawsuit asking a Delaware court to rule that its proposed generic of Boehringer Ingelheim’s lung disease treatment Ofev does not infringe two patents.

More on this story

Europe
3 June 2020   Israeli generic drugmaker Teva Pharmaceuticals must face infringement claims related to an asthma inhaler, an English judge has ruled.
Big Pharma
4 January 2019   Teva Pharmaceuticals has announced that it has resolved a dispute with Amgen over Teva’s generic cinacalcet HCI product.
Generics
8 March 2022   Mumbai-based pharma company Cipla has filed a lawsuit asking a Delaware court to rule that its proposed generic of Boehringer Ingelheim’s lung disease treatment Ofev does not infringe two patents.

More on this story

Europe
3 June 2020   Israeli generic drugmaker Teva Pharmaceuticals must face infringement claims related to an asthma inhaler, an English judge has ruled.
Big Pharma
4 January 2019   Teva Pharmaceuticals has announced that it has resolved a dispute with Amgen over Teva’s generic cinacalcet HCI product.
Generics
8 March 2022   Mumbai-based pharma company Cipla has filed a lawsuit asking a Delaware court to rule that its proposed generic of Boehringer Ingelheim’s lung disease treatment Ofev does not infringe two patents.