Patent dispute over Gilead’s HIV and HBV medications resolved with many generic drugmakers


Gilead Sciences (NASDAQ:GILD)

On Monday, Gilead Sciences (NASDAQ:GILD), a pharmaceutical company based in the United States, announced the conclusion of patent litigation and other disputes with various generic pharmaceutical firms over its HIV medications Descovy and Odefsey and its Vemlidy treatment for hepatitis B virus.

GILD disclosed the settlements in a regulatory filing, and the parties involved included Canada’s Apotex and India’s Lupin, Macleods Pharma, Hetero Labs, and Cipla.

The patents on tenofovir alafenamide covering Descovy and Vemlidy run out on October 31, 2031, while Odefsey’s run out on January 31, 2032; the agreements provide the generic drugmakers a non-exclusive license to use those patents in the United States.

After 2031 and 2032, generic drugmakers will be able to produce their own versions of the HIV and HBV medications, but until then, Gilead (GILD) will have a monopoly on the market.

RBC Capital Markets research analyst Brian Abrahams wrote in a short research note, “We regard (the settlements) as a big positive for the HIV franchise longevity the $3B in sales these medicines produce, and see the potential for stock gain on today’s news.”

As the market opened, GILD shares were up $4.30, or 4.3%, to $68.10.

Gilead Sciences (NASDAQ:GILD) recently revealed that its antibody-drug combination Trodelvy demonstrated a statistically significant and clinically relevant increase of 3.2 months in overall survival (OS) over chemotherapy in specific patients with HR+/HER2- metastatic breast cancer.

The data come from the Phase 3 TROPiCS-02 study, in which 543 patients were randomly assigned to receive either Trodelvy or the investigators’ preferred treatment. All of the participants in this study had received prior endocrine therapy and at least two prior chemotherapies for metastatic illness.

The trial’s secondary goal, overall survival, showed that patients in the Trodelvy arm had a median OS of 14.4 months, compared to 11.2 months in the comparison arm. This translated to a 3.2-month advantage against those in the TPC arm.

Another important secondary goal, objective response rate (ORR), showed statistically significant improvement in favor of Trodelvy compared to TPC in this experiment.

The safety profile of Trodelvy in TROPiCS-02 was similar to earlier trials for the medication, GILD stated, adding that there were no new safety flags.

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