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Generated: September 23, 2018

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NORETHINDRONE Drug Profile

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When do Norethindrone patents expire, and when can generic versions of Norethindrone launch?

Norethindrone is a drug marketed by Accord Hlthcare, Amneal Pharms, Glenmark Generics, Lupin Ltd, Mylan Labs Ltd, Novast Labs, Novast Labs Ltd, Aurobindo Pharma Ltd, Barr, Barr Labs Inc, Glenmark Pharms Ltd, Mayne Pharma, Chemo Research Sl, Apotex Inc, Watson Labs, Watson Pharms Teva, Watson Labs Teva, and Apil. and is included in sixty NDAs. There is one patent protecting this drug.

The generic ingredient in NORETHINDRONE is mestranol; norethindrone. There are eleven drug master file entries for this compound. One supplier is listed for this compound. There are three tentative approvals for this compound. Additional details are available on the mestranol; norethindrone profile page.

Drug patent expirations by year for NORETHINDRONE
Pharmacology for NORETHINDRONE
Ingredient-typeProgesterone Congeners
Drug ClassProgestin
Synonyms for NORETHINDRONE
(17-alpha)-17-Hydroxy-19-norpregn-4-en-20-yn-3-one
(17alpha)-17-ethynyl-17-hydroxyestra-4,8(14),9-trien-3-one
(17alpha)-17-hydroxy-19-norpregn-4-en-20-yn-3-one
(17beta)-17-ethynyl-17-hydroxyestr-4-en-3-one
(1S,2R,10R,11S,14R,15S)-14-ethynyl-14-hydroxy-15-methyltetracyclo[8.7.0.0?,?.0??,??]heptadec-6-en-5-one
(1S,2R,10R,11S,14R,15S)-14-ETHYNYL-14-HYDROXY-15-METHYLTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADEC-6-EN-5-ONE
(8R,9S,10R,13S,14S,17R)-17-ethynyl-17-hydroxy-13-methyl-1,2,6,7,8,9,10,11,12,13,14,15,16,17-tetradecahydro-3H-cyclopenta[a]phenanthren-3-one
(8R,9S,10R,13S,14S,17R)-17-ethynyl-17-hydroxy-13-methyl-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one
(8R,9S,10R,13S,14S,17R)-17-Ethynyl-17-hydroxy-13-methyl-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3(2H)-one
067N596
13-methyl-17alpha-ethynyl-17-hydroxygon-4-en-3-one
17-alpha-19-Norpregn-4-en-20-yn-3-one, 17-hydroxy-
17-alpha-Ethinyl-17-beta-hydroxy-delta(sup:4)-estren-3-one
17-alpha-Ethinylestra-4-en-17-beta-ol-3-one
17-alpha-Ethynyl-17-beta-hydroxy-19-norandrost-4-en-3-one
17-alpha-Ethynyl-17-beta-hydroxy-4-estren-3-one
17-alpha-Ethynyl-17-hydroxy-4-estren-3-one
17-alpha-Ethynyl-19-norandrost-4-en-17-beta-ol-3-one
17-alpha-Ethynyl-19-nortestosterone
17-alpha-Ethynyl-4-estren-17-ol-3-one
17-beta-Hydroxy-19-norpregn-4-en-20-yn-3-one
17-Ethinyl-19-nor-testosterone
17-Ethinyl-19-nortestosterone
17-Ethynyl-17-hydroxyestr-4-en-3-one
17-Ethynyl-17-hydroxyestr-4-en-3-one (ACD/Name 4.0)
17-ethynyl-17beta-hydroxyestr-4-en-3-one
17-Ethynyl-19-Nortestosterone
17-Hydroxy-(17alpha)-19-Norpregn-4-en-20-yn-3-one
17-Hydroxy-17-alpha-19-norpregn-4-en-20-yn-3-one
17-Hydroxy-19-nor-17-alpha-pregn-4-en-20-yn-3-one
17-Hydroxy-19-nor-17alpha-4-pregnen-20-yn-3-one
17-Hydroxy-19-nor-17alpha-pregn-4-en-20-yn-3-one
17-hydroxy-19-nor-17alpha-pregn-4-en-20yn-3-one
17.alpha.-Ethinyl-19-nortestosterone
17.alpha.-Ethynyl-19-nortestosterone
17.alpha.-Ethynyl-4-estren-17-ol-3-one
17alpha-Ethinyl-17alpha-Ethinyl-19-nortestosterone
17alpha-Ethinyl-17beta-hydroxy-delta(sup:4)-estren-3-one
17alpha-Ethinyl-19-nortestosterone
17alpha-Ethinylestra-4-en-17beta-ol-3-one
17alpha-Ethynyl-17 beta-hydroxy-19-nor-4-androsten-3-one
17alpha-Ethynyl-17-hydroxy-4-estren-3-one
17alpha-ethynyl-17-hydroxy-Estr-4-en-3-one
17alpha-Ethynyl-17-hydroxyest-4-en-3-one
17alpha-Ethynyl-17beta-hydroxy-19-nor-4-androsten-3-one
17alpha-Ethynyl-17beta-hydroxy-19-norandrost-4-en-3-one
17alpha-Ethynyl-17beta-hydroxyestr-4-en-3-one
17alpha-Ethynyl-19-nor-4-androsten-17beta-ol-3-one
17alpha-Ethynyl-19-norandrost-4-en-17beta-ol-3-one
17alpha-Ethynyl-19-nortestosterone
17alpha-Ethynyl-3-oxo-4-estren-17beta-ol
17alpha-Ethynyl-4-estren-17-ol-3-one
17alpha-hydroxy-19-norpregn-4-en-20-yn-3-one
17alpha-pregn-4-en-20-yn-3-one
17beta-Hydroxy-17alpha-ethynylestr-4-en-3-one
17beta-Hydroxy-19-norpregn-4-en-20-yn-3-one
19-Nor-17-alpha-ethynyl-17-beta-hydroxy-4-androsten-3-one
19-Nor-17-alpha-ethynylandrosten-17-beta-ol-3-one
19-Nor-17-alpha-ethynyltestosterone
19-Nor-17-alpha-pregn-4-en-20-yn-3-one, 17-hydroxy-
19-Nor-17-ethinyl testosterone
19-Nor-17-ethinyltestosterone
19-Nor-17.alpha.-ethynyltestosterone
19-Nor-17alpa-ethynyltestosterone
19-Nor-17alpha-ethynyl-17beta-hydroxy-4-androsten-3-one
19-Nor-17alpha-ethynyl-4-androsten-17beta-ol-3-one
19-nor-17alpha-Ethynylandrosten-17beta-ol-3-one
19-Nor-17alpha-ethynyltestosterone
19-Nor-17alpha-pregn-4-en-20-yn-3-one, 17-hydroxy-
19-Nor-17alpha-pregn-4-en-20-yn-3-one, 17-hydroxy- (8CI)
19-Nor-ethindrone
19-Nor-ethinyl--4,5-testosterone
19-Nor-ethinyl-4,5-testosterone
19-Norethindrone
19-Norethindrone, >=98%, powder
19-Norethindrone, VETRANAL(TM), analytical standard
19-Norethinyltestosterone
19-Norethisterone
19-Norpregn-4-en-20-yn-3-one, 17-hydroxy-, (17alpha)-
19-Norpregn-4-en-20-yn-3-one,17-hydroxy-, (17a)-
19-Nortestosterone, 17-ethynyl-
3B1-007314
4-Estren-17alpha-ethynyl-17beta-ol-3-one
68-22-4
AC-11100
AC1L1M2R
Activella
AI3-26422
AK307564
AKOS005267172
AN-829
Anhydrohydroxynorprogesterone
Anovulatorio
Anovule
ARONIS24281
BB_NC-0600
BBC/437
BDBM50148732
BPBio1_000074
BRD-K92073408-001-03-3
Brevicon
Brevinor
Brevinor 21
Brevinor 28
Brevinor-1 21
Brevinor-1 28
BRN 1915671
BSPBio_000066
C05028
Camila
Camila (TN)
CAS-68-22-4
CCG-220253
CCRIS 484
CHEBI:7627
CHEMBL1162
Ciclovulan
CJ-22223
component of Noriday
Conceplan
Conludaf
Conludag
CPD000499579
CS-2664
D00182
D0GL7U
DB00717
Demulen
DSSTox_CID_3380
DSSTox_GSID_23380
DSSTox_RID_77005
DTXSID9023380
EINECS 200-681-6
ENT
Errin
Estr-4-en-3-one, 17alpha-ethynyl-17-hydroxy-
Estrinor
Ethinyl-19-nortestosterone
Ethinylnortestosterone
Ethynylmortestosterone
Ethynylnortestosterone
Gencept
Genora
Gestest
GTPL2880
HMS1568D08
HMS2090D21
HMS2095D08
HMS2231E18
HMS3259C16
HSDB 3370
HY-B0554
Jenest
Jenest-28
KS-000048I5
LMST02030097
Loestrin
LS-97425
MCULE-9156628994
Menzol
MFCD00067596
Microneth
Micronett
Micronor
Micronor (TN)
Micronovum
Milli
Mini-Pe
Mini-pill
Minovlar
MLS001076679
MLS001163874
MolPort-002-507-131
N.E.E
N.E.E.
N0449
NC00576
NCGC00094738-01
NCGC00179669-01
NCGC00179669-02
NCGC00179669-04
NCGC00255187-01
Nelova
NET
Nodiol
Nor-Q.D
Nor-Q.D.
Nor-QD
Nora-BE
Noraethisteronum
Noralutin
Norcept
Norcept-E
Norcolut
Norcolute
Noresthisterone
Norethadrone
Norethin
Norethin 1/35 E
Norethin 1/50 M
Norethindirone
Norethindrone (Norethisterone)
Norethindrone (Norethisterone), pharmaceutical secondary standard; traceable to USP, PhEur, BP
Norethindrone (USP)
Norethindrone [USAN]
Norethindrone [USP]
Norethindrone Norethisterone
Norethindrone, United States Pharmacopeia (USP) Reference Standard
Norethisteron
Norethisterone
Norethisterone (JP15)
Norethisterone (JP17)
norethisterone (norethindrone)
Norethisterone [Progestins]
Norethisterone for system suitability, European Pharmacopoeia (EP) Reference Standard
Norethisterone, European Pharmacopoeia (EP) Reference Standard
Norethisteronum
Norethisteronum [INN-Latin]
Norethyndron
Norethynodron
Norethynodrone
Noretisterona
Noretisterona [INN-Spanish]
Noretisterone
Noretisterone [DCIT]
Norfor
Norgestin
Noriday
Noriday 28
Norluten
Norlutin
Norluton
Normapause
Norpregneninlone
Norpregneninolone
Norpregneninotone
NSC-9564
Orlest
Ortho 1 35
Ortho 7 7 7
Ortho-novum
Ortho-Novum 1 35
Ortho-Novum 1 50
Ortho-Novum 7 7 7
Ovcon
Ovysmen 0.5 35
Ovysmen 1 35
PL039325
Prestwick_646
Prestwick0_000253
Prestwick1_000253
Prestwick2_000253
Prestwick3_000253
Primolut N
Primolut-N
Primolut-N (TN)
Proluteasi
RP17635
s4040
SC 4640
SC-16223
SCHEMBL23390
SMR000499579
SPBio_002285
SR-01000765382
SR-01000765382-3
Synphase
Synphasic 28
T18F433X4S
Tox21_111322
Tox21_111322_1
Tox21_302427
Tri-Norinyl
Triella
Trinovum 21
UNII-T18F433X4S
Utovlan
Utovlar
VIKNJXKGJWUCNN-XGXHKTLJSA-N
W-104686
ZINC85205451

US Patents and Regulatory Information for NORETHINDRONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-28 200897-001 May 11, 2015 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apotex Inc NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate TABLET;ORAL 208639-001 Mar 21, 2018 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Watson Labs NORETHINDRONE AND ETHINYL ESTRADIOL (10/11) ethinyl estradiol; norethindrone TABLET;ORAL-21 071043-001 Apr 1, 1988 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Watson Labs NORETHINDRONE AND MESTRANOL mestranol; norethindrone TABLET;ORAL-21 070758-001 Jul 1, 1988 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Labs Ltd NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-28 203006-001 Aug 5, 2013 RX No Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Watson Labs Teva NORETHINDRONE AND ETHINYL ESTRADIOL (10/11) ethinyl estradiol; norethindrone TABLET;ORAL-28 071044-001 Apr 1, 1988 RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Apil NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 022573-001 Dec 22, 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

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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Cipla
Medtronic
Cantor Fitzgerald
Moodys
McKinsey
McKesson
UBS
Federal Trade Commission

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