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Last Updated: March 28, 2024

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


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What are the generic drug 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 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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Evofem Inc PHEXXI citric acid; lactic acid; potassium bitartrate GEL;VAGINAL 208352-001 May 22, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Evofem Inc PHEXXI citric acid; lactic acid; potassium bitartrate GEL;VAGINAL 208352-001 May 22, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Evofem Inc PHEXXI citric acid; lactic acid; potassium bitartrate GEL;VAGINAL 208352-001 May 22, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Ukraine 115876 КОМПОЗИЦІЯ І СПОСІБ ПІДВИЩЕННЯ ЕФЕКТИВНОСТІ БАКТЕРИЦИДНИХ ЗАСОБІВ КОНТРАЦЕПЦІЇ (COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES) ⤷  Try a Trial
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) ⤷  Try a Trial
Russian Federation 2016129069 КОМПОЗИЦИИ И СПОСОБЫ ИНГИБИРОВАНИЯ ВОСПАЛЕНИЯ И ЗАБОЛЕВАНИЙ С ПРИМЕНЕНИЕМ АНТИМИКРОБНОГО СОЕДИНЕНИЯ НА ОСНОВЕ АЛЬГИНОВОЙ КИСЛОТЫ ⤷  Try a Trial
South Africa 201500111 COMPOSITIONS AND METHODS FOR ENHANCING THE EFFICACY OF CONTRACEPTIVE MICROBICIDES ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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