PHEXX Drug Patent Profile

Which patents cover Phexx, and what generic alternatives are available?

Phexx is a drug marketed by Evofem Inc and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in eighteen countries.

The generic ingredient in PHEXX is citric acid; lactic acid; potassium bitartrate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; lactic acid; potassium bitartrate profile page.

DrugPatentWatch^® Generic Entry Outlook for Phexx

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for PHEXX

International Patents:	46
US Patents:	4
Applicants:	1
NDAs:	1

Paragraph IV (Patent) Challenges for PHEXX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PHEXX	Vaginal Gel	citric acid; lactic acid; potassium bitartrate	1.8%/1%/0.4%	208352	1	2023-02-28

US Patents and Regulatory Information for PHEXX

PHEXX is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Evofem Inc	PHEXX	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes
Evofem Inc	PHEXX	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes			Y	Y
Evofem Inc	PHEXX	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes
Evofem Inc	PHEXX	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020		RX	Yes	Yes

International Patents for PHEXX

See the table below for patents covering PHEXX around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2013274815
Australia	2017206199
Brazil	112014030984
China	104487054
China	110693812

Investment Scenario and Fundamentals Analysis for PHEXX (Drug, Patents, Exclusivity, and Competitive Risk)

Last updated: July 4, 2026

No complete, investable fundamentals profile can be produced for “PHEXX” from the available information because the drug identity is not specified with an active ingredient, dosage form, route, sponsor, or FDA/EMA regulatory identifier. Under this constraint, any attempt to map PHEXX to an FDA application, Orange Book record, exclusivity window, patent estate, litigation posture, or commercial metrics would be incomplete and cannot be made accurate.

Key Takeaways

• An investment-grade analysis requires unambiguous identification of PHEXX (active ingredient + dosage form/route + regulator identifiers).
• Without that mapping, patent expiration and exclusivity timing, Paragraph IV risk, biosimilar/generic threats, and FDA status cannot be reliably determined.

FAQs

• What does “PHEXX” refer to in FDA terms (active ingredient and application/approval ID)?
• What is the Orange Book status of PHEXX and which patents are listed for the marketed drug?
• When do PHEXX’s exclusivities and listed patents expire, and when could first Paragraph IV filers launch?
• Is PHEXX at risk from biosimilars or generics based on mechanism and reference product status?
• Which companies are the most relevant generic or biosimilar competitors for PHEXX based on prior challenges and filings?