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. Four suppliers are listed for this compound.

Summary for ULIPRISTAL ACETATE

International Patents:	65
US Patents:	8
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	56
Patent Applications:	2,385
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

Sponsor	Phase
University of Colorado, Denver	Phase 2
University of North Carolina, Chapel Hill	Phase 2
University of Utah	Early Phase 1

See all ULIPRISTAL ACETATE clinical trials

Pharmacology for ULIPRISTAL ACETATE

Drug Class	Progesterone Agonist/Antagonist
Mechanism of Action	Selective Progesterone Receptor Modulators

Anatomical Therapeutic Chemical (ATC) Classes for ULIPRISTAL ACETATE

G03AD	Emergency contraceptives
G03A	HORMONAL CONTRACEPTIVES FOR SYSTEMIC USE
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

G03XB	Progesterone receptor modulators
G03X	OTHER SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

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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

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Country	Patent Number	Title	Estimated Expiration
Japan	5784502		⤷ Sign Up
Lithuania	2365800		⤷ Sign Up
Spain	2596554		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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