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PHEXXI Drug Patent Profile

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

Phexxi 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 sixty-five patent family members in twenty-three countries.

The generic ingredient in PHEXXI 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 Phexxi

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 PHEXXI

International Patents:	65
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	3
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PHEXXI
What excipients (inactive ingredients) are in PHEXXI?	PHEXXI excipients list
DailyMed Link:	PHEXXI at DailyMed

See drug prices for PHEXXI

Recent Clinical Trials for PHEXXI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Queen's Medical Center	Early Phase 1
University of Hawaii Foundation	Early Phase 1
Parexel	Phase 3

See all PHEXXI clinical trials

Pharmacology for PHEXXI

Drug Class	Anti-coagulant Calculi Dissolution Agent
Mechanism of Action	Acidifying Activity Calcium Chelating Activity
Physiological Effect	Decreased Coagulation Factor Activity

Anatomical Therapeutic Chemical (ATC) Classes for PHEXXI

A09AB	Acid preparations
A09A	DIGESTIVES, INCL. ENZYMES
A09	DIGESTIVES, INCL. ENZYMES
A	Alimentary tract and metabolism

G01AD	Organic acids
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for PHEXXI

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

US Patents and Regulatory Information for PHEXXI

PHEXXI is protected by four US patents.

Patents protecting PHEXXI

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

Expired US Patents for PHEXXI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Evofem Inc	PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352-001	May 22, 2020

International Patents for PHEXXI

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

Country	Patent Number	Title	Estimated Expiration
South Korea	102407408
European Patent Office	3735966	COMPOSITIONS ET MÉTHODES POUR L'INHIBITION D'UNE INFLAMMATION ET DE MALADIES À L'AIDE D'UN COMPOSÉ ANTIMICROBIEN À BASE D'ACIDE ALGINIQUE (COMPOSITIONS AND METHODS FOR INHIBITING INFLAMMATION AND DISEASES USING AN ALGINIC ACID-BASED ANTIMICROBIAL COMPOUND)
Mexico	2014015307	COMPOSICIONES Y MÉTODOS PARA MEJORAR LA EFICACIA DE MICROBICIDAS ANTICONCEPTIVOS. (COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES.)
Singapore	11201408243V	COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES
Israel	246146	תכשירים מווסתי חומציות למניעת הריון, באמצעות תרכובת אנטי מיקרוביאלית מבוססת חומצה אלגינית (Acid buffering contraceptive compositions using an alginic acid-based antimicrobial compound)