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Last Updated: May 12, 2021

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Ulipristal acetate - Generic Drug Details

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What are the generic drug sources for ulipristal acetate and what is the scope of patent protection?

Ulipristal acetate is the generic ingredient in two branded drugs marketed by Lab Hra Pharma and Teva Pharms Usa, and is included in two NDAs. There are eight patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ulipristal acetate has sixty-five patent family members in twenty-eight countries.

There are six drug master file entries for ulipristal acetate. Three suppliers are listed for this compound.

Summary for ulipristal acetate
Recent Clinical Trials for ulipristal acetate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of UtahEarly Phase 1
Merck Sharp & Dohme Corp.Early Phase 1
HOPE Research Center, Ho Chi Minh City, Viet NamPhase 4

See all ulipristal acetate clinical trials

Pharmacology for ulipristal acetate
Paragraph IV (Patent) Challenges for ULIPRISTAL ACETATE
Tradename Dosage Ingredient NDA Submissiondate
ELLA TABLET;ORAL ulipristal acetate 022474 2014-08-13

US Patents and Regulatory Information for ulipristal acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa LOGILIA ulipristal acetate TABLET;ORAL 207952-001 Feb 13, 2017 AB RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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