Evofem Biosciences Announces FDA Orange Book Listing of Two Additional U.S. Patents for Phexxi

Rhea-AI Summary

Evofem Biosciences (OTCQB: EVFM) announced the addition of two new patents for Phexxi®, its contraceptive product, to the FDA Orange Book. The newly awarded patents, covering the formulation and its method of use, extend the company's patent portfolio until March 2033. The '989 patent', issued on May 24, 2022, and the '610 patent', issued on September 13, 2022, further strengthen the intellectual property protection for Phexxi. CEO Saundra Pelletier emphasized the importance of expanding their patent estate for future growth opportunities in both U.S. and global markets.

Positive

• Addition of two new patents for Phexxi enhances intellectual property portfolio.
• Patents valid until March 2033, providing extended market exclusivity.

Negative

• None.

-- Evofem now has four Orange Book listed patents covering Phexxi into 2033 -- 

SAN DIEGO, Feb. 27, 2023 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCQB: EVFM) today announced that two additional U.S. patents which cover Phexxi® (lactic acid, citric acid and potassium bitartrate) and its labeled indication are now listed in the U.S. Food and Drug Administration (FDA) publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

"The Orange Book listing of these two patents covering Phexxi's composition of matter and its method of use in contraception is an important step in further strengthening our patent portfolio," said Evofem Biosciences CEO Saundra Pelletier. "We plan to further expand our intellectual property estate in the U.S. and overseas as we continue to iterate our vaginal pH modulator platform and seek entry into global markets."

The newly listed U.S. Patent No. 11,337,989 (the '989 patent) covers contraception using the L-Lactic Acid Phexxi formulation. The '989 patent was issued by the U.S. Patent and Trademark Office (USPTO) on May 24, 2022 and is expected to expire in March 2033. 

The newly listed U.S. Patent No. 11,439,610 (the '610 patent) covers compositions containing L-Lactic Acid, including the Phexxi formulation. The '610 patent was issued by the USPTO on September 13, 2022 and is expected to expire in March 2033. 

About Evofem

Evofem Biosciences, Inc., is developing and commercializing innovative products to address unmet needs in women's sexual and reproductive health. The Company's first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Learn more at phexxi.com and evofem.com.

Phexxi^® is a registered trademark of Evofem Biosciences, Inc.

Forward-Looking Statements
This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995 including, without limitation, statements related to ­­­­­the expected duration of the issued patents and Evofem's plans to further expand its intellectual property estate, to iterate its vaginal pH modulator platform, and to enter into global markets. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on March 10, 2022, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 filed with the SEC on January 6, 2023 and any subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law.

Contact
Amy Raskopf
SVP, Investor Relations
Evofem Biosciences, Inc.
araskopf@evofem.com / media@evofem.com
(917) 673-5775

 

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SOURCE Evofem Biosciences, Inc.

FAQ

What patents did Evofem announce for Phexxi?

Evofem announced two new U.S. patents for Phexxi covering its composition and method of use, which are now listed in the FDA Orange Book.

When do the new patents for Phexxi expire?

The new patents for Phexxi are expected to expire in March 2033.

How does the Orange Book listing impact Evofem?

The Orange Book listing provides Evofem with enhanced intellectual property protection and market exclusivity for Phexxi.

What is the significance of the new patents for Evofem?

The new patents strengthen Evofem's patent portfolio, supporting future growth and market expansion plans.