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Last Updated: May 25, 2024

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 freedom to operate?

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 four 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:4
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
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

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 ⤷  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 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
>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 citric acid; lactic acid; potassium bitartrate

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2013187984 ⤷  Sign Up
Japan 6738573 ⤷  Sign Up
Ukraine 115876 КОМПОЗИЦІЯ І СПОСІБ ПІДВИЩЕННЯ ЕФЕКТИВНОСТІ БАКТЕРИЦИДНИХ ЗАСОБІВ КОНТРАЦЕПЦІЇ (COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES) ⤷  Sign Up
Mexico 2014015307 COMPOSICIONES Y MÉTODOS PARA MEJORAR LA EFICACIA DE MICROBICIDAS ANTICONCEPTIVOS. (COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES.) ⤷  Sign Up
Germany 60143566 ⤷  Sign Up
Mexico 2021001742 COMPOSICIONES Y METODOS PARA INHIBIR LA INFLAMACION Y LAS ENFERMEDADES UTILIZANDO UN COMPUESTO ANTIMICROBIANO CON BASE EN ACIDO ALGINICO. (COMPOSITIONS AND METHODS FOR INHIBITING INFLAMMATION AND DISEASES USING AN ALGINIC ACID-BASED ANTIMICROBIAL COMPOUND.) ⤷  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.