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Generated: July 18, 2018

DrugPatentWatch Database Preview

Norethindrone acetate - Generic Drug Details

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What are the generic drug sources for norethindrone acetate and what is the scope of norethindrone acetate patent protection?

Norethindrone acetate
is the generic ingredient in three branded drugs marketed by Duramed Res, Amneal Pharms, Aurobindo Pharma Ltd, Barr, Glenmark Generics, Mylan Labs Ltd, and Parke Davis, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for norethindrone acetate. Eight suppliers are listed for this compound. There are three tentative approvals for this compound.
Pharmacology for norethindrone acetate
Ingredient-typeProgesterone Congeners
Drug ClassProgestin
Synonyms for norethindrone acetate
(17-.alpha.)-17-(Acetyloxy)-19-norpregn-4-en-20-yn-3-one
(17-alpha)-17-(Acetyloxy)-19-norpregn-4-en-20-yn-3-one
(17-alpha)-Norethindrone acetate
(17-ethynyl-13-methyl-3-oxidanylidene-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl) ethanoate
(17-ethynyl-13-methyl-3-oxo-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl) acetate
(17alpha)-3-oxo-19-norpregn-4-en-20-yn-17-yl acetate
(17beta)-17-ethynyl-3-oxoestr-4-en-17-yl acetate
(1S,11S,15S,2R,10R,14R)-14-ethynyl-15-methyl-5-oxotetracyclo[8.7.0.0<2,7>.0<11 ,15>]heptadec-6-en-14-yl acetate
(1S,2R,10R,11S,14R,15S)-14-ETHYNYL-15-METHYL-5-OXOTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADEC-6-EN-14-YL ACETATE
(1S,2R,10R,11S,14S,15S)-14-ETHYNYL-15-METHYL-5-OXOTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADEC-6-EN-14-YL ACETATE
[(10R,13S,17R)-17-ethynyl-13-methyl-3-oxo-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl] acetate
[(8R,9S,10R,13S,14S,17R)-17-ethynyl-13-methyl-3-oxo-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl] acetate
[(8R,9S,10R,13S,14S,17S)-17-ethynyl-13-methyl-3-oxo-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl] acetate
039N850
17-Acetoxy-19-nor-17-alpha-pregn-4-en-20-yn-3-one
17-Acetoxy-19-nor-17.alpha.-pregn-4-en-20-yn-3-one
17-Acetoxy-19-nor-17alpha-pregn-4-en-20-yn-3-one
17-Acetoxy-19-norpregna-4-ene-20-yne-3-one
17-Acetyloxy(17-alpha)-19-norpregn-4-estren-17-beta-ol-acetate-3-one
17-Acetyloxy(17.alpha.)-19-norpregn-4-estren-17.beta.-ol-acetate-3-one
17-alpha-Ethinyl-19-nortestosterone acetate
17-alpha-Ethinyl-19-nortestosterone-17-beta-acetate
17-alpha-Ethynyl-17-beta-acetoxy-19-norandrost-4-en-3-one
17-alpha-Ethynyl-17-hydroxyestr-4-en-3-one acetate
17-alpha-Ethynyl-19-nortestosterone acetate
17-Hydroxy-19-nor-17-alpha-pregn-4-en-20-yn-3-one acetate
17-Hydroxy-19-nor-17.alpha.-pregn-4-en-20-yn-3-one acetate
17-Hydroxy-19-nor-17alpha-pregn-4-en-20-yn-3-one acetate
17-oC>>u-19-E yen(1/4)x-17|A-OEthcThorn-4-I(c)-20-E(2)>>u-3-I feminine OOEao yen
17.alpha.-Ethinyl-19-nortestosterone 17.beta.-acetate
17.alpha.-Ethinyl-19-nortestosterone acetate
17.alpha.-Ethinyl-19-nortestosterone-17.beta.-acetate
17.alpha.-Ethynyl-17-hydroxyestr-4-en-3-one acetate
17.alpha.-Ethynyl-17.beta.-acetoxy-19-norandrost-4-en-3-one
17.alpha.-Ethynyl-17.beta.-hydroxyestr-4-en-3-one acetate
17.alpha.-Ethynyl-19-nortestosterone acetate
17.alpha.-Ethynyl-3-oxoestr-4-en-17.beta.-yl acetate
17.beta.-Acetoxy-19-nor-17.alpha.-pregn-4-en-20-yn-3-one
17.beta.-Hydroxy-19-nor-17.alpha.-pregn-4-en-20-yn-3-one acetate
17|A-OOE(2)>>u-17|A-oC>>u-19-E yen(1/4)x-4-EthUcThornI(c)-3-I feminine 17-OOEao yen
17|A-OOE(2)>>u-19-E yen(1/4)xO masculineI feminine 17|A-OOEao yen
17alpha-acetoxy-17beta-ethynyl-4-estren-3-one
17alpha-Ethinyl-19-nortestosterone 17beta-acetate
17alpha-Ethinyl-19-nortestosterone-17beta-acetate
17alpha-Ethynyl-17 beta-hydroxy-19-nor-4-androsten-3-one 17-acetate
17alpha-Ethynyl-17-hydroxyestr-4-en-3-one acetate
17alpha-Ethynyl-17beta-acetoxy-19-norandrost-4-en-3-one
17alpha-Ethynyl-19-nortestosterone 17 beta-acetate
17alpha-Ethynyl-19-nortestosterone acetate
17beta-Acetoxy-19-nor-17alpha-pregn-4-en-20-yn-3-one
17beta-Hydroxy-19-nor-17alpha-pregn-4-en-20-yn-3-one acetate
19-Nor-17-alpha-pregn-4-en-20-yn-3-one, 17-acetoxy-
19-nor-17.alpha.-Pregn-4-en-20-yn-3-one, 17-acetoxy-
19-Nor-17.alpha.-pregn-4-en-20-yn-3-one, 17-hydroxy-, acetate
19-Nor-17.alpha.-pregn-4-en-20-yn-3-one, acetate
19-Nor-17alpha-ethynyltestosterone Acetate
19-nor-17alpha-Pregn-4-en-20-yn-3-one, 17-acetoxy-
19-Nor-17alpha-pregn-4-en-20-yn-3-one, 17-hydroxy-, acetate
19-Nor-17alpha-pregn-4-en-20-yn-3-one, 17-hydroxy-, acetate (8CI)
19-Norethindrone acetate
19-Norethindrone acetate, VETRANAL(TM), analytical standard
19-Norethindroneacetate
19-Norethisterone acetate
19-Norethynyltestosterone acetate
19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17.alpha.)
19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17.alpha.)-
19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17alpha)
38673-38-0
51-98-9
9S44LIC7OJ
A828876
AB00052057_07
AB00052057-05
AC-11101
AC1L1L8N
AC1L1Y81
AC1LBS17
AC1NWAP0
AC1Q1L8G
acetic acid (17-ethynyl-13-methyl-3-oxo-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-17-yl) ester
AJ-32012
AK116022
AK322345
AKOS015960495
AKOS016010517
AKOS027326742
AKOS030488694
Ambap51-98-9
AN-24400
AS-13383
Aygestin
Aygestin (TN)
BRD-K96037667-001-01-4
BRN 2064104
BSPBio_002103
C08152
CAS-51-98-9
CC-33073
CCG-39690
CCRIS 485
CHEBI:7628
CHEMBL1201146
CHEMBL1357114
CJ-30393
component of Anovlar (Salt/Mix)
component of Estrostep (Salt/Mix)
component of Etalontin (Salt/Mix)
component of Minovlar (Salt/Mix)
component of Primosiston (Salt/Mix)
CPD000718763
CPD001906776
CS-7730
CTK5J0457
D00953
D0T6RH
DivK1c_000150
DSSTox_CID_1071
DSSTox_GSID_23381
DSSTox_RID_77006
DTXSID4023381
E yen(1/4)x>>uINCaoCOEthI feminine 17-OOEao yen
EINECS 200-132-0
EN300-295970
EN300-49856
ENTA
Estr-4-en-3-one, 17.alpha.-ethynyl-17-hydroxy-, acetate
Estr-4-en-3-one, 17alpha-ethynyl-17-hydroxy-, acetate
Ethinyl-nortestosterone acetate
Gestakadin
HMS1920B12
HMS2091J12
HMS2232M22
HMS3259A16
HMS500H12
HY-B1710
I039
IDI1_000150
IMONTRJLAWHYGT-REGVOWLASA-N
IMONTRJLAWHYGT-ZCPXKWAGSA-N
KB-277958
KBio1_000150
KBio2_000941
KBio2_003509
KBio2_006077
KBio3_001603
KBioGR_000639
KBioSS_000941
LS-97419
MCULE-9767919428
MFCD04039850
Milli-Anovlar
Milligynon
Miniphase
MLS001304004
MolPort-000-714-663
MolPort-002-509-456
MolPort-003-901-032
MolPort-006-823-108
Monogest
N0450
NC00575
NCGC00159500-02
NCGC00178818-01
NCGC00183366-01
NINDS_000150
Norethindrone 17-acetate
Norethindrone acetate (transdermal patch, female contraception), Watson Pharmaceuticals
Norethindrone acetate (USP)
Norethindrone acetate [USP]
Norethindrone acetate, United States Pharmacopeia (USP) Reference Standard
Norethisteron acetate
Norethisterone acetate
Norethisterone acetate (JAN)
Norethisterone acetate (Norethindrone acetate)
Norethisterone acetate for system suitability, European Pharmacopoeia (EP) Reference Standard
Norethisterone acetate, European Pharmacopoeia (EP) Reference Standard
Norethynyltestosterone acetate
Norethysterone acetate
Norlutate
Norlutin A
Norlutin acetate
Norlutin-A
Norlutine acetate
NPD5721
NSC 22844
NSC-22844
NSC-757248
NSC22844
NSC757248
Oprea1_864672
Orlutate
Pharmakon1600-01500438
PL000269
PL055693
Primodos (Salt/Mix)
Primolut-Nor
Progestin (transdermal patch, female contraception)
Progestin (transdermal patch, female contraception), Watson Pharmaceuticals
Progylut
SAM002548939
SAM002564222
SBI-0051462.P003
SC-65535
SCHEMBL11321479
SCHEMBL14360522
SCHEMBL37530
SH 420
SH-420C
SMR000718763
SPBio_001046
Spectrum_000461
SPECTRUM1500438
Spectrum2_001063
Spectrum3_000522
Spectrum4_000080
Spectrum5_001238
SR-01000837509
SR-01000837509-2
ST075199
ST24038260
STOCK1N-03961
Testerone, 19-nor-17alpha-ethynyl-, acetate
Tox21_113371
UNII-9S44LIC7OJ
W-105857
WLN: L E5 B666 OV MUTJ E FOV1 F1UU1 -B&EF
ZINC1833
ZINC1849528
Tentative approvals for NORETHINDRONE ACETATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial1MG;0.01MG;75MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial1MG;0.02MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial75MGTABLET;ORAL

US Patents and Regulatory Information for norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 204236-001 Jan 8, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Amneal Pharms NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 200275-001 Jul 30, 2012 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Barr NORETHINDRONE ACETATE norethindrone acetate TABLET;ORAL 075951-001 May 25, 2001 AB RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Parke Davis NORLUTATE norethindrone acetate TABLET;ORAL 012184-002 Approved Prior to Jan 1, 1982 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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