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 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 |


DrugPatentWatch® Estimated Generic Entry Opportunity Date for PHEXXI
Generic Entry Date for PHEXXI*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT 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
Sponsor | Phase |
---|---|
Parexel | Phase 3 |
Evofem Inc. | Phase 3 |
Health Decisions | Phase 3 |
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
US Patents and Regulatory Information for PHEXXI
PHEXXI is protected by two US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of PHEXXI is See Plans and Pricing.
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
Compositions and methods for enhancing the efficacy of contraceptive microbicides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PREVENTION OF PREGNANCY
Compositions and methods for trapping and inactivating pathogenic microbes and spermatozoa
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting PHEXXI
NEW PRODUCT
Exclusivity Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Evofem Inc | PHEXXI | citric acid; lactic acid; potassium bitartrate | GEL;VAGINAL | 208352-001 | May 22, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Evofem Inc | PHEXXI | citric acid; lactic acid; potassium bitartrate | GEL;VAGINAL | 208352-001 | May 22, 2020 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 |
---|---|---|---|
Mexico | 365905 | COMPOSICIONES Y MÉTODOS PARA MEJORAR LA EFICACIA DE MICROBICIDAS ANTICONCEPTIVOS. (COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES.) | See Plans and Pricing |
Israel | 151649 | תכשרים ושיטות ללכידת והשבתת חידקים פתוגניים וספרמטוזוה (Compositions and methods for trapping and inactivating pathogenic microbes and spermatozoa) | See Plans and Pricing |
Singapore | 11201408243V | COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES | See Plans and Pricing |
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) | See Plans and Pricing |
South Korea | 102062599 | See Plans and Pricing | |
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) | See Plans and Pricing |
Eurasian Patent Organization | 201590008 | КОМПОЗИЦИИ И СПОСОБЫ ПОВЫШЕНИЯ ЭФФЕКТИВНОСТИ БАКТЕРИЦИДНЫХ СРЕДСТВ КОНТРАЦЕПЦИИ | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |