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Ulipristal acetate - Generic Drug Details

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What are the generic sources for ulipristal acetate and what is the scope of ulipristal acetate 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 five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Summary for ulipristal acetate

US Patents:	5
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	6
Suppliers / Packagers:	3
Bulk Api Vendors:	51
Clinical Trials:	47
Patent Applications:	56
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ulipristal acetate
DailyMed Link:	ulipristal acetate at DailyMed

Pharmacology for ulipristal acetate

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

Synonyms for ulipristal acetate

(10S,11S,14R,15S,17R)-14-acetyl-17-[4-(dimethylamino)phenyl]-15-methyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-1,6-dien-14-yl acetate

(10S,11S,14R,15S,17R)-14-acetyl-17-[4-(dimethylamino)phenyl]-15-methyl-5-oxotetracyclo[8.7.0.0?,?.0??,??]heptadeca-1,6-dien-14-yl acetate

(10S,11S,14R,15S,17R)-14-ACETYL-17-[4-(DIMETHYLAMINO)PHENYL]-15-METHYL-5-OXOTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADECA-1,6-DIEN-14-YL ACETATE

(11beta,17alpha)-17-acetyl-11-[4-(dimethylamino)phenyl]-3-oxoestra-4,9-dien-17-yl acetate

(11beta)-17-(Acetyloxy)-11-(4-(dimethylamino)phenyl)-19-norpregna-4,9-diene-3,20-dione

(11beta)-17-(Acetyloxy)-11-[4-(dimethylamino)phenyl]-19-norpregna-4,9-diene-3,20-dione

(8S,11R,13S,14S,17R)-17-acetyl-11-(4-(dimethylamino)phenyl)-13-methyl-3-oxo-2,3,6,7,8,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-17-yl acetate

[(8S,11R,13S,14S,17R)-17-acetyl-11-(4-dimethylaminophenyl)-13-methyl-3-oxo-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-17-yl] acetate

126784-99-4

17-Acetoxy-11-(4-N,N-dimethylaminophenyl)pregna-4,9-diene-3,20-dione

17beta-acetyl-11beta-[4-(dimethylamino)phenyl]-3-oxoestra-4,9-dien-17alpha-yl acetate

19-Norpregna-4,9-diene-3,20-dione, 17-(acetyloxy)-11-(4-(dimethylamino)phenyl)-, (11beta)-

19-Norpregna-4,9-diene-3,20-dione,17-(acetyloxy)-11-[4-(dimethylamino)phenyl]-, (11b)-

3B1-000818

4oar

5-(Hydroxymethyl)-alpha,alpha,alpha,alpha-tetramethyl-1,3-benzenediacetonitrile

784A994

AB01566874_01

AC1L2Y8A

AKOS026750526

AMX10180

BDBM50375424

C30H37NO4

CBD 2914; VA 2914; (11b)-17-(Acetyloxy)-11-[4-(dimethylamino)phenyl]-19-norpregna-4,9-diene-3,20-dione

CDB 2914

CDB-2914

CHEBI:71025

CHEMBL260538

CS-1157

D09687

DTXSID30155294

Ella

EllaOne

EllaOne|||Esmya

EN300-220766

Esmya

FT-0675731

GTPL7460

Hrp-2000

HY-16508

J-005436

KB-81383

KS-00000Z24

MolPort-006-170-077

OOLLAFOLCSJHRE-ZHAKMVSLSA-N

PL009540

RTI 3021-012

SC-44720

SCHEMBL544957

U0102

Ulipristal (acetate)

Ulipristal acet

Ulipristal acetate (JAN/USAN)

Ulipristal acetate [USAN]

Ulipristal acetate, >=98% (HPLC)

Ulipristal acetate(CDB2914)

Ulipristal-Acetate

UNII-YF7V70N02B

VA2914

W-5201

X4788

YF7V70N02B

Z2216208644

ZINC3920657

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
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
Teva Pharms Usa	LOGILIA	ulipristal acetate	TABLET;ORAL	207952-001	Feb 13, 2017	AB	RX	No	No
Lab Hra Pharma	ELLA	ulipristal acetate	TABLET;ORAL	022474-001	Aug 13, 2010	AB	RX	Yes	Yes

International Patents for ulipristal acetate

Country	Document Number	Estimated Expiration
Japan	2015107994
European Patent Office	2419108
New Zealand	595790
Portugal	2365800
South Africa	201107543
Russian Federation	2492853