CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE - Generic Drug Details

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What are the generic sources for citric acid; lactic acid; potassium bitartrate and what is the scope of patent protection?

Citric acid; lactic acid; potassium bitartrate is the generic ingredient in one branded drug marketed by Evofem Inc and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Citric acid; lactic acid; potassium bitartrate has sixty-five patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

International Patents:	65
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE at DailyMed

Pharmacology for CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

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 CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

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 CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

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 CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

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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	Y	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				⤷ 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			⤷ 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 CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

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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 CITRIC ACID; LACTIC ACID; POTASSIUM BITARTRATE

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Country	Patent Number	Title	Estimated Expiration
China	100488517		⤷ Sign Up
Japan	2020125298	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 (COMPOSITIONS AND METHODS FOR INHIBITING INFLAMMATION AND DISEASES BY USING ALGINIC ACID-BASED ANTIMICROBIAL COMPOUNDS)	⤷ 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
Hungary	0301417		⤷ 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
>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.