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Last Updated: February 20, 2020

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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 seven 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. One supplier is listed for this compound.

Recent Clinical Trials for ulipristal acetate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
HOPE Research Center, Ho Chi Minh City, Viet NamPhase 4
Mỹ Đức HospitalPhase 4
Stanford UniversityEarly Phase 1

See all ulipristal acetate clinical trials

Recent Litigation for ulipristal acetate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Laboratoire HRA Pharma v. Teva Pharmaceuticals USA Inc.2015-01-16

See all ulipristal acetate litigation

Pharmacology for ulipristal acetate
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
(11alpha,13alpha,17beta)-17-acetyl-11-[4-(dimethylamino)phenyl]-3-oxoestra-4,9-dien-17-yl acetate
(11b)-17-(Acetyloxy)-11-[4-(dimethylamino)phenyl]-19-norpregna-4,9-diene-3,20-dione
(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
[(8s,11r,13s,14s,17r)-17-Acetyl-11-[4-(Dimethylamino)phenyl]-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)-
4oar
5-(Hydroxymethyl)-alpha,alpha,alpha,alpha-tetramethyl-1,3-benzenediacetonitrile
784A994
AB01566874_01
AC1L2Y8A
AKOS026750526
AMX10180
BDBM50375424
BRD-K64381438-001-03-8
C30H37NO4
CBD 2914
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
FT-0675731
GTPL7460
Hrp-2000
HY-16508
J-005436
KB-81383
KS-00000Z24
MolPort-006-170-077
NCGC00378913-02
OOLLAFOLCSJHRE-ZHAKMVSLSA-N
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
Paragraph IV (Patent) Challenges for ULIPRISTAL ACETATE
Tradename Dosage Ingredient NDA Submissiondate
ELLA TABLET;ORAL ulipristal acetate 022474 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   Start Trial   Start Trial Y   Start Trial
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Lab Hra Pharma ELLA ulipristal acetate TABLET;ORAL 022474-001 Aug 13, 2010 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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