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Last Updated: March 3, 2024

PHEXXI Drug Patent Profile


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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 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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 6, 2024. This may change due to patent challenges or generic licensing.

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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  Try a Trial

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
Drug Prices for PHEXXI

See drug prices for PHEXXI

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PHEXXI
Generic Entry Date for PHEXXI*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Queen's Medical CenterEarly Phase 1
University of Hawaii FoundationEarly Phase 1
ParexelPhase 3

See all PHEXXI clinical trials

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 and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PHEXXI is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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

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

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

Compositions and methods for enhancing the efficacy of contraceptive microbicides
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compositions and methods for trapping and inactivating pathogenic microbes and spermatozoa
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting PHEXXI

NEW PRODUCT
Exclusivity Expiration: ⤷  Try a Trial

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

International Patents for PHEXXI

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

Country Patent Number Title Estimated Expiration
Israel 151649 תכשרים ושיטות ללכידת והשבתת חידקים פתוגניים וספרמטוזוה (Compositions and methods for trapping and inactivating pathogenic microbes and spermatozoa) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2015095793 ⤷  Try a Trial
Denmark 3082826 ⤷  Try a Trial
Mexico 365905 COMPOSICIONES Y MÉTODOS PARA MEJORAR LA EFICACIA DE MICROBICIDAS ANTICONCEPTIVOS. (COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES.) ⤷  Try a Trial
Canada 2402589 COMPOSITIONS ET PROCEDES PERMETTANT DE PIEGER ET D'INACTIVER LES MICROBES PATHOGENES ET LES SPERMATOZOIDES (COMPOSITIONS AND METHODS FOR TRAPPING AND INACTIVATING PATHOGENIC MICROBES AND SPERMATOZOA) ⤷  Try a Trial
Russian Federation 2002126560 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.