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Last Updated: December 8, 2022

Ulipristal acetate - Generic Drug Details


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What are the generic 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 North Carolina, Chapel HillPhase 2
University of UtahEarly Phase 1
Merck Sharp & Dohme Corp.Early Phase 1

See all ulipristal acetate clinical trials

Pharmacology for ulipristal acetate
Paragraph IV (Patent) Challenges for ULIPRISTAL ACETATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ELLA Tablets ulipristal acetate 30 mg 022474 1 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
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for ulipristal acetate

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Laboratoire HRA Pharma ellaOne ulipristal acetate EMEA/H/C/001027
Emergency contraception within 120 hours (five days) of unprotected sexual intercourse or contraceptive failure.
Authorised no no no 2009-05-15
Gedeon Richter Plc. Ulipristal Acetate Gedeon Richter ulipristal acetate EMEA/H/C/005017
Ulipristal acetate is indicated for one treatment course of pre-operative treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age.Ulipristal acetate is indicated for intermittent treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age who are not eligible for surgery.
Withdrawn no no no 2018-08-27
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for ulipristal acetate

Country Patent Number Title Estimated Expiration
Serbia 55331 POSTUPAK ZA KONTRACEPCIJU PO POTREBI (METHOD FOR ON-DEMAND CONTRACEPTION) See Plans and Pricing
China 102395373 Method for on-demand contraception See Plans and Pricing
Israel 213247 טבליות אוליפריסטל אצטט (Ulipristal acetate tablets) See Plans and Pricing
Japan 5784502 See Plans and Pricing
Portugal 2365800 See Plans and Pricing
Russian Federation 2492853 ТАБЛЕТКИ НА ОСНОВЕ УЛИПРИСТАЛА АЦЕТАТА (TABLETS OF ULIPRISTAL ACETATE) See Plans and Pricing
Canada 2745084 COMPRIMES D'ULIPRISTAL ACETATE (ULIPRISTAL ACETATE TABLETS) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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