Details for New Drug Application (NDA): 208352

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NDA 208352 describes PHEXXI, which is a drug marketed by Evofem Inc and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the PHEXXI profile page.

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.

Summary for 208352

Tradename:	PHEXXI
Applicant:	Evofem Inc
Ingredient:	citric acid; lactic acid; potassium bitartrate
Patents:	4

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 208352

Generic Entry Date for 208352^: ⤷ Get Started Free* Constraining patent/regulatory exclusivity: ⤷ Get Started Free 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 NDA: 208352

Mechanism of Action	Acidifying Activity Calcium Chelating Activity
Physiological Effect	Decreased Coagulation Factor Activity

Suppliers and Packaging for NDA: 208352

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352	NDA	Evofem, Inc.	69751-100	69751-100-03	3 APPLICATOR in 1 BOX (69751-100-03) / 5 g in 1 APPLICATOR (69751-100-01)
PHEXXI	citric acid; lactic acid; potassium bitartrate	GEL;VAGINAL	208352	NDA	Evofem, Inc.	69751-100	69751-100-12	12 APPLICATOR in 1 BOX (69751-100-12) / 5 g in 1 APPLICATOR (69751-100-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	GEL;VAGINAL			Strength	1%;1.8%;0.4%
Approval Date:	May 22, 2020	TE:		RLD:	Yes
Patent:	⤷ Get Started Free	Patent Expiration:	Mar 15, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF PREGNANCY
Patent:	⤷ Get Started Free	Patent Expiration:	Mar 15, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	PREVENTION OF PREGNANCY
Patent:	⤷ Get Started Free	Patent Expiration:	Mar 15, 2033	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 208352

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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	⤷ Get Started Free	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.