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Last Updated: April 4, 2020

DrugPatentWatch Database Preview

NORETHINDRONE AND ETHINYL ESTRADIOL Drug Profile


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Which patents cover Norethindrone And Ethinyl Estradiol, and when can generic versions of Norethindrone And Ethinyl Estradiol launch?

Norethindrone And Ethinyl Estradiol is a drug marketed by Watson Labs, Watson Pharms Teva, Accord Hlthcare, Mayne Pharma, Mylan Labs Ltd, Watson Labs Teva, Amneal Pharms, Apil, Barr, and Lupin Ltd. and is included in twenty-four NDAs. There is one patent protecting this drug.

The generic ingredient in NORETHINDRONE AND ETHINYL ESTRADIOL is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

US ANDA Litigation and Generic Entry Outlook for Norethindrone And Ethinyl Estradiol

There is one tentative approval for the generic drug (ethinyl estradiol; norethindrone), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Summary for NORETHINDRONE AND ETHINYL ESTRADIOL
Drug patent expirations by year for NORETHINDRONE AND ETHINYL ESTRADIOL
Recent Clinical Trials for NORETHINDRONE AND ETHINYL ESTRADIOL

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

SponsorPhase
University of VirginiaN/A
Ironwood Pharmaceuticals, Inc.Phase 1
Eisai Inc.Phase 1

See all NORETHINDRONE AND ETHINYL ESTRADIOL clinical trials

Synonyms for NORETHINDRONE AND ETHINYL ESTRADIOL
(17 alpha)-17-hydroxy-19-norpregn-4-en-20-yn-3-one, mixture with (17 alpha)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol
(17alpha)-17-Hydroxy-19-norpregn-4-en-20-yn-3-one, mixture with (17alpha)-19-norpregna-1,3,5(10)-trien-20-yne-3,17-diol
17-Hydroxy-19-norpregn-4-en-20-yn-3-one--19-norpregna-1(10),2,4-trien-20-yne-3,17-diol (1/1)
19-Nor-17-alpha-pregn-4-en-20-yn-3-one, 17-hydroxy-, mixed with 19-nor-17-alpha-pregna-1,3,5(10)-trien-20-yne-3,17-diol
37270-71-6
Alyacen 1/35
Alyacen 7/7/7
Aranelle
Balziva
Balziva-21
Balziva-28
Binovum
BREVICON 21-DAY
BREVICON 28-DAY
Brevion
C20H24O2.C20H26O2
Con-fer
Cyclafem 1/35
Cyclafem 7/7/7
Cyonanz
DT 5061
DT 5062
DT-5061
DT-5062(1/35)
DTXSID00958416
Duagynon
E-Con
Ethinyl estradiol mixture with norethindrone
ETHINYL ESTRADIOL; NORETHINDRONE
Ethinylestradiol-norethisterone mixt
Ethinylestradiol-norethisterone mixt.
Ethynyl estradiol / norethindrone
Ethynylestradiol / norethindrone
Ethynylestradiol mixed with norethindrone
ethynylestradiol mixture with norethindrone
Eve 20
Femcon Fe
GENCEPT 10/11-21
GENCEPT 10/11-28
Gynovlar
Kaitlib Fe
Leena
Lo Minastrin Fe
LoDose
LS-178555
LS-97443
MODICON 21
MODICON 28
N.E.E. 1/35 21
N.E.E. 1/35 28
N049500000
Necon 7/7/7 28-Day Tablets
Neocon
Netasyn
NORCEPT-E 1/35 21
NORCEPT-E 1/35 28
NORETHIN 1/35E-21
NORETHIN 1/35E-28
Norethindron-ethinylestradiol mixt
Norethindron-ethinylestradiol mixt.
Norethindrone / Ethinyl estradiol
norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)
Norethindrone Ethinyl Estradiol
Norethindrone mixed with ethynylestradiol
Norethindrone mixture with ethinyl estradiol
Norethindrone-ethinylestradiol mixt
Norethindrone-ethinylestradiol mixt.
Norethisterone mixed with ethinyl oestradiol
Norethisterone-ethinylestradiol mixt
Norethisterone-ethinylestradiol mixt.
Norethisterone-ethynylestradiol mixt
Norethisterone-ethynylestradiol mixt.
Norimen
Norimin
Norinyl 1 35
Norinyl 1-35
NORINYL 1+35 21-DAY
NORINYL 1+35 28-DAY
Norminest
Nortrel 0.5/35-21
Nortrel 0.5/35-28
Nortrel 1/35-21
Nortrel 1/35-28
Nortrel 7/7/7
Nylia 1/35
Nylia 7/7/7
Oestro-primolut
Ortho Novum 7-7-7
Ortho-Novum 1/35
ORTHO-NOVUM 1/35-21
ORTHO-NOVUM 1/35-28
Ortho-novum 10/11
ORTHO-NOVUM 10/11-21
Ortho-Novum 10/11-28
ORTHO-NOVUM 7/14-21
ORTHO-NOVUM 7/14-28
Ortho-novum 7/7/7
ORTHO-NOVUM 7/7/7-21
ORTHO-NOVUM 7/7/7-28
Ortho-Novum 777
Ovcon 35
Ovcon 50
OVCON-35
OVCON-50
Ovyrmen
Ovysmen
Primidos
SCHEMBL3835489
SH 7.1122
SH B 259 AB
TRI-NORINYL 21-DAY
TRI-NORINYL 28-DAY
Trinovum
Zenchent
Zoran

US Patents and Regulatory Information for NORETHINDRONE AND ETHINYL ESTRADIOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-21 078379-001 Feb 23, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 207066-001 Mar 29, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 202086-001 Apr 1, 2015 AB RX No Yes   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-28 200486-001 Dec 28, 2015 DISCN No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-28 206864-001 Apr 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs NORETHINDRONE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone TABLET;ORAL-28 076393-001 Feb 4, 2010 DISCN No No   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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Serving leading biopharmaceutical companies globally:

Baxter
Johnson and Johnson
AstraZeneca
Merck
Medtronic
Moodys

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