shutterstock_1522630529_penpics_studio
PENpics Studio / Shutterstock.com
13 September 2022AmericasStaff Writer

Big pharma firm settles HIV drug disputes with generic makers

Gilead had filed patent infringement proceedings lawsuit against five companies | Drug makers will receive non-exclusive licences starting from Halloween 2031.

Gilead has settled patent disputes with five generic makers over proposed generic versions of two of its HIV drugs and a hepatitis B drug.

In a US Securities and Exchange Commission (SEC) filing submitted yesterday, September 12, Gilead confirmed it had entered into agreements with Lupin, Apotex, Macleods Pharma, Hetero Labs and Cipla.

The agreements resolve the litigation and patent challenges associated with HIV drugs Descovy (emtricitabine/tenofovir) and Odefsey (emtricitabine, rilpivirine and tenofovir alafenamide), and hepatitis B drug Vemlidy (tenofovir alafenamide) at the US District Court for the District of Delaware.

The five generic makers will receive a non-exclusive licences in the US to Gilead’s patents on tenofovir alafenamide relating to Descovy and Vemlidy beginning on October 31, 2031, and to Odefsey beginning on January 31, 2032.

While the filing didn’t disclose further details of the settlement, Gilead did state that the licences may begin "earlier in certain circumstances”.

In a series of filings between Thursday and Sunday, the drugmaker told the Delaware court that it had resolved the cases. The trial was meant to begin on 12 September.

Gilead had filed suit against the generic makers back in February 2020 after they had filed Abbreviated New Drug Applications to market generic versions of Gilead’s products containing tenofovir alafenamide.

In 2021, Gilead sold more than $380 million of Vemlidy, more than $1.2 billion of Descovy and more than $1 billion of Odefsey in the US.

Did you enjoy reading this story?  Sign up to our free daily newsletters and get stories sent like this straight to your inbox.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk


More on this story

Big Pharma
31 March 2022   Gilead Sciences has failed to prevent insurer Aetna from pursuing its lawsuit in a US state court, as it faces a spate of antitrust complaints alleging that it used pay-for-delay deals to maintain the high costs of HIV drugs.
Americas
20 January 2022   Gilead Sciences has sued an array of pharmaceutical suppliers and distributors accusing them of forming a counterfeiting network and allegedly selling fake versions of its HIV medications.

More on this story

Big Pharma
31 March 2022   Gilead Sciences has failed to prevent insurer Aetna from pursuing its lawsuit in a US state court, as it faces a spate of antitrust complaints alleging that it used pay-for-delay deals to maintain the high costs of HIV drugs.
Americas
20 January 2022   Gilead Sciences has sued an array of pharmaceutical suppliers and distributors accusing them of forming a counterfeiting network and allegedly selling fake versions of its HIV medications.

More on this story

Big Pharma
31 March 2022   Gilead Sciences has failed to prevent insurer Aetna from pursuing its lawsuit in a US state court, as it faces a spate of antitrust complaints alleging that it used pay-for-delay deals to maintain the high costs of HIV drugs.
Americas
20 January 2022   Gilead Sciences has sued an array of pharmaceutical suppliers and distributors accusing them of forming a counterfeiting network and allegedly selling fake versions of its HIV medications.