DrugPatentWatch Database Preview
phexxi Drug Profile
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When do Phexxi patents expire, 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 |
| Suppliers / Packagers: | 1 |
| 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.
Pharmacology for phexxi
| Drug Class | Calculi Dissolution Agent Anti-coagulant |
| Mechanism of Action | Acidifying Activity Calcium Chelating Activity |
| Physiological Effect | Decreased Coagulation Factor Activity |
US Patents and Regulatory Information for 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 | Start Trial | Start Trial | Start Trial | ||||
| Evofem Inc | PHEXXI | citric acid; lactic acid; potassium bitartrate | GEL;VAGINAL | 208352-001 | May 22, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Evofem Inc | PHEXXI | citric acid; lactic acid; potassium bitartrate | GEL;VAGINAL | 208352-001 | May 22, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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
| 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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for phexxi
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 0166084 | Start Trial |
| Mexico | 2019007176 | Start Trial |
| Japan | 2018109034 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
