Ulipristal acetate - Generic Drug Details

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

International Patents:	65
US Patents:	8
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	54
Patent Applications:	2,899
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 North Carolina, Chapel Hill	Phase 2
University of Utah	Early Phase 1
Merck Sharp & Dohme Corp.	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

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

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

International Patents for ulipristal acetate

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