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Covington
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Daiichi Sankyo
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Generated: September 25, 2018

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Ethinyl estradiol; norethindrone - Generic Drug Details

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What are the generic drug sources for ethinyl estradiol; norethindrone and what is the scope of ethinyl estradiol; norethindrone freedom to operate?

Ethinyl estradiol; norethindrone is the generic ingredient in one hundred and ten branded drugs marketed by Apil, Lupin Ltd, Aurobindo Pharma Ltd, Accord Hlthcare, Amneal Pharms, Barr, Mylan Labs Ltd, Allergan Sales Llc, Ortho Mcneil Pharm, LPI, Watson Pharms Teva, Watson Labs, Watson Labs Teva, Ortho Mcneil Janssen, Janssen Pharms, Warner Chilcott, Mayne Pharma, Glenmark Generics, Vintage Pharms, Vintage Pharms Llc, Novast Labs Ltd, Warner Chilcott Llc, Lupin Atlantis, Chemo Research Sl, Glenmark Pharms Ltd, Barr Labs Inc, Apotex Inc, Parke Davis, and Glenmark Pharms, and is included in one hundred and forty NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for ethinyl estradiol; norethindrone. Twenty suppliers are listed for this compound. There are two tentative approvals for this compound.

Pharmacology for ethinyl estradiol; norethindrone
Synonyms for ethinyl estradiol; norethindrone
(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
(1S,10R,11S,14R,15S)-14-ETHYNYL-15-METHYLTETRACYCLO[8.7.0.0(2),?.0(1)(1),(1)?]HEPTADECA-2,4,6-TRIENE-5,14-DIOL; (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-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one; (8R,9S,13S,14S,17R)-17-ethynyl-13-methyl-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanth
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
53464-69-0
AC1L1Y1Y
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
DT 5061
DT 5062
DT-5061
DT-5062(1/35)
Duagynon
E-Con
Ethinyl estradiol mixture with norethindrone
Ethinylestradiol-norethisterone mixt
Ethinylestradiol-norethisterone mixt.
Ethynylestradiol mixed with norethindrone
ethynylestradiol mixture with norethindrone
Eve 20
Femcon Fe
GENCEPT 10/11-21
GENCEPT 10/11-28
Gynovlar
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 AND ETHINYL ESTRADIOL
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
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
PL055333
Primidos
SCHEMBL3835489
SH 7.1122
SH B 259 AB
TRI-NORINYL 21-DAY
TRI-NORINYL 28-DAY
Trinovum
Zenchent
Zoran
Tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up0.02MG;1MGTABLET, CHEWABLE;ORAL
➤ Sign Up➤ Sign Up0.01MG,0.01MG;1MG,N/ATABLET;ORAL

US Patents and Regulatory Information for ethinyl estradiol; norethindrone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novast Labs Ltd LARIN 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 202996-001 Mar 20, 2014 AB RX No No ➤ 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
Lupin Ltd PIRMELLA 7/7/7 ethinyl estradiol; norethindrone TABLET;ORAL-28 201510-001 Apr 24, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Glenmark Generics NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL 203038-001 Apr 2, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Ortho Mcneil Pharm ORTHO-NOVUM 7/14-28 ethinyl estradiol; norethindrone TABLET;ORAL-28 019004-002 Apr 4, 1984 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Mylan Labs Ltd NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 202741-001 Feb 20, 2015 AB RX No No ➤ Sign Up ➤ Sign Up ➤ 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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Expired US Patents for ethinyl estradiol; norethindrone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 022573-001 Dec 22, 2010 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO-NOVUM 7/7/7-28 ethinyl estradiol; norethindrone TABLET;ORAL-28 018985-002 Apr 4, 1984 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO-NOVUM 7/7/7-28 ethinyl estradiol; norethindrone TABLET;ORAL-28 018985-002 Apr 4, 1984 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO-NOVUM 7/7/7-28 ethinyl estradiol; norethindrone TABLET;ORAL-28 018985-002 Apr 4, 1984 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO-NOVUM 7/7/7-21 ethinyl estradiol; norethindrone TABLET;ORAL-21 018985-001 Apr 4, 1984 ➤ Sign Up ➤ Sign Up
Janssen Pharms ORTHO-NOVUM 7/7/7-21 ethinyl estradiol; norethindrone TABLET;ORAL-21 018985-001 Apr 4, 1984 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
McKesson
Daiichi Sankyo
Boehringer Ingelheim
Mallinckrodt
Moodys
Harvard Business School
McKinsey
Accenture

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