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PHEXXI Drug Patent Profile

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When do Phexxi patents expire, 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

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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

Drug patent expirations by year for PHEXXI

Recent Clinical Trials for PHEXXI

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

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

Compositions and methods for enhancing the efficacy of contraceptive microbicides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTION OF PREGNANCY

Compositions and methods for inhibiting inflammation and diseases using an alginic acid-based antimicrobial compound
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTION OF PREGNANCY

Compositions and methods for enhancing the efficacy of contraceptive microbicides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Compositions and methods for trapping and inactivating pathogenic microbes and spermatozoa
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Patent Expiration: ⤷ Sign Up

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Glossary

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

Expired US Patents for PHEXXI

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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	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PHEXXI

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

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2016129069	КОМПОЗИЦИИ И СПОСОБЫ ИНГИБИРОВАНИЯ ВОСПАЛЕНИЯ И ЗАБОЛЕВАНИЙ С ПРИМЕНЕНИЕМ АНТИМИКРОБНОГО СОЕДИНЕНИЯ НА ОСНОВЕ АЛЬГИНОВОЙ КИСЛОТЫ	⤷ Sign Up
Japan	2022070924	アルギン酸をベースとする抗菌性化合物を使用して炎症と疾患を阻害するための組成物及び方法	⤷ Sign Up
China	106029078	使用基于藻酸的抗微生物化合物抑制炎症和疾病的组合物和方法 (Compositions and methods for inhibiting inflammation and diseases using an alginic acid-based antimicrobial compound)	⤷ Sign Up
South Korea	102062599		⤷ Sign Up
European Patent Office	3082826	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)	⤷ Sign Up
Australia	2001243431		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration