PHEXXI Drug Patent Profile

Which patents cover Phexxi, and when can generic versions of Phexxi launch?

Phexxi is a drug marketed by Evofem Inc and is included in one NDA. There are two patents protecting this drug.

This drug has forty-three patent family members in twenty-two 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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 22, 2023. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for PHEXXI

International Patents:	43
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
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

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for PHEXXI

Constraining patent/regulatory exclusivity:

NEW PRODUCT

NDA:

208352

Dosage:

GEL;VAGINAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for PHEXXI

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

Sponsor	Phase
Parexel	Phase 3
Evofem Inc.	Phase 3
Health Decisions	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

US Patents and Regulatory Information for PHEXXI

PHEXXI is protected by two US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW PRODUCT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting PHEXXI

FDA Regulatory Exclusivity 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

International Patents for PHEXXI

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

Country	Patent Number	Title	Estimated Expiration
Mexico	365905	COMPOSICIONES Y MÉTODOS PARA MEJORAR LA EFICACIA DE MICROBICIDAS ANTICONCEPTIVOS. (COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES.)
Israel	151649	תכשרים ושיטות ללכידת והשבתת חידקים פתוגניים וספרמטוזוה (Compositions and methods for trapping and inactivating pathogenic microbes and spermatozoa)
Singapore	11201408243V	COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES
European Patent Office	1263411	Compositions et leurs utilisation permettant de piéger et d'inactiver les microbes pathogènes et les spermatozoïdes (Compositions and use thereof for trapping and inactivating pathogenic microbes and spermatozoa)
South Korea	102062599
Russian Federation	2274442	КОМПОЗИЦИИ И СПОСОБЫ УЛАВЛИВАНИЯ И ИНАКТИВАЦИИ ПАТОГЕННЫХ МИКРООРГАНИЗМОВ И СПЕРМАТОЗОИДОВ (COMPOSITIONS AND METHODS FOR ENTRAPPING AND INACTIVATION OF PATHOGENIC MICROORGANISMS AND SPERMATOZOIDS)
Eurasian Patent Organization	201590008	КОМПОЗИЦИИ И СПОСОБЫ ПОВЫШЕНИЯ ЭФФЕКТИВНОСТИ БАКТЕРИЦИДНЫХ СРЕДСТВ КОНТРАЦЕПЦИИ