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Ulipristal acetateis 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
|Drug Master File Entries:||6|
|Finished Product Suppliers / Packagers:||3|
|Raw Ingredient (Bulk) Api Vendors:||73|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for ulipristal acetate|
|What excipients (inactive ingredients) are in ulipristal acetate?||ulipristal acetate excipients list|
|DailyMed Link:||ulipristal acetate at DailyMed|
Recent Clinical Trials for ulipristal acetate
Identify potential brand extensions & 505(b)(2) entrants
|University of North Carolina, Chapel Hill||Phase 2|
|University of Utah||Early Phase 1|
|Merck Sharp & Dohme Corp.||Early Phase 1|
Pharmacology for ulipristal acetate
|Drug Class||Progesterone Agonist/Antagonist |
|Mechanism of Action|| Selective Progesterone Receptor Modulators |
|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.
|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.
|>Company||>Drugname||>Inn||>Product Number / Indication||>Status||>Generic||>Biosimilar||>Orphan||>Marketing Authorisation||>Marketing Refusal|
|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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