Sanofi Annual Report 2022

Sanofi are protecting their Jevtana® patent vigorously

In the jurisdictions where this product has patent expiration the generic drug is eating into sales as do all generics when they come off patent

And Starpharma have their own patent for Dep Cabazitaxel (Jevtana®

An improved formulation of Sanofi's

It is not rocket science to see that Sanofi is the front runner to either purchase Starpharma's improved version and put an end to any competition with the generics


FYI

Sanofi Annual Report 2022 referring to Cabazitaxel (Jevtana®

Jevtana® (cabazitaxel), a chemotherapy drug and cytotoxic agent, is a semi-synthetic second-generation taxane that prevents many cancer cells from dividing, which ultimately results in destroying many such cells. It is approved in combination with prednisone for the treatment of patients with metastatic castration resistant prostate cancer previously treated with a docetaxel containing treatment regimen. Jevtana® was granted marketing authorization by the FDA in June 2010, by the European Commission in March 2011, and in Japan in July 2014. The product is marketed in over 75 countries. In Europe, generic competition started for Jevtana® from the end of March 2021. In the US, the Jevtana® composition of matter patent expired in September 2021. Sanofi has filed patent infringement suits under the US Hatch-Waxman Act against generic manufacturers for cabazitaxel in the US District Court for the District of Delaware asserting three Orange Book listed US patents for Jevtana®. Sanofi has entered settlement agreements with some of the defendants and the suit against the remaining defendants is ongoing; see Note D.22.b. to the consolidated financial statements, included at Item 18. of this annual report.

Jevtana® (cabazitaxel) Compound: Expired Later filed patents: coverage ranging through October 2030 NCE Regulatory exclusivity: December 2023 Compound: expired Later filed patents: coverage ranging through May 2036 (pending) Regulatory exclusivity: expired Compound: expired Later filed patents: coverage ranging through November 2030 Regulatory exclusivity: July 2022

Jevtana® posted net sales of €391 million in 2022 (-20.0% CER), as sales decreased in Europe (-70.5% CER at €33 million) following the arrival of generic competition in some European markets at end March 2021. In the United States, Jevtana® is currently covered by four Orange Book listed patents: US 7,241,907, US 8,927,592, US 10,583,110 and US 10,716,777. Sanofi has filed patent infringement suits under Hatch-Waxman against generic filers asserting the ‘110 patent, the ‘777 patent and the '592 patent in the US District Court for the District of Delaware. Sanofi has since reached settlement agreements with most of the defendants, and the suit against the remaining defendant (Sandoz) is ongoing. In August 2022, the district court dismissed Sanofi’s infringement claim related to the ‘592 patent. A three-day trial took place on January 11 through January 13, 2023, and Sandoz agreed not to launch any generic cabazitaxel product until the earlier of a district court decision in favor of Sandoz or four months after the completion of the post-trial briefing. Jevtana® sales in the United States were down 3.2% CER at €275 million.

Jevtana® (cabazitaxel)-related patent litigation in the US Jevtana® is currently covered by four Orange Book listed patents US 7,241,907, US 8,927,592, US 10,583,110 and US 10,716,777. In May to July 2020, Sanofi filed patent infringement suits under Hatch-Waxman against 12 generic filers asserting the ‘110 patent and the ‘777 patent in the US District Court for the District of Delaware. The '592 patent was added to the suits after its amended claims issued in August 2021. In January 2021 and August 2022, the District Court issued two claim construction decisions in favor of the defendants. In September 2022, the district court issued a decision that granted the defendants’ motion to dismiss in part related to the ‘592 patent but denied the motion to dismiss in part related to the ‘777 and ‘110 patents. Sanofi has reached settlement agreements with most of the defendants and the suit against the remaining defendant Sandoz is ongoing. Sanofi has voluntarily withdrawn the ‘110 patent from the suit and a 3-day trial on the ‘777 patent was held in January 2023. Sandoz has agreed not to launch any generic cabazitaxel product until the earlier of a district court decision in favor of the defendants or 120 days after the completion of the post-trial briefing.