Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Boehringer Ingelheim
Baxter
Express Scripts
Merck

Last Updated: December 14, 2019

DrugPatentWatch Database Preview

Ethinyl estradiol; norethindrone - Generic Drug Details

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

What are the generic sources for ethinyl estradiol; norethindrone and what is the scope of patent protection?

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, Glenmark Pharms Ltd, Xiromed, Novast Labs, Barr Labs Inc, Apotex Inc, Glenmark Pharms, and Parke Davis, 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. Sixteen suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for ethinyl estradiol; norethindrone

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

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

See all ethinyl estradiol; norethindrone clinical trials

Recent Litigation for ethinyl estradiol; norethindrone

Identify potential future generic entrants

District Court Litigation
Case NameDate
Teva Women's Health, Inc. v. Famy Care Ltd.2014-12-05
Warner Chilcott Company, LLC v. Lupin Ltd.2014-01-27
Bayer Intellectual Property GMBH v. Warner Chilcott Company LLC2012-08-13

See all ethinyl estradiol; norethindrone litigation

Generic filers with tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial0.01MG,0.01MG;1MG,N/ATABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
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
Cyonanz
DT 5061
DT 5062
DT-5061
DT-5062(1/35)
Duagynon
E-Con
Ethinyl estradiol mixture with 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
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
Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; NORETHINDRONE
Tradename Dosage Ingredient NDA Submissiondate
ORTHO-NOVUM 7/7/7-21 TABLET;ORAL-21 ethinyl estradiol; norethindrone 018985
ORTHO-NOVUM 7/7/7-28 TABLET;ORAL-28 ethinyl estradiol; norethindrone 018985

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
Allergan Sales Llc BREVICON 21-DAY ethinyl estradiol; norethindrone TABLET;ORAL-21 017566-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd AUROVELA FE 1.5/30 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 207580-001 Jun 15, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Apil MINASTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 203667-001 May 8, 2013 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Amneal Pharms NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 207514-001 Sep 11, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Barr NORTREL 7/7/7 ethinyl estradiol; norethindrone TABLET;ORAL-28 075478-002 Aug 30, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Pharms Teva NORETHIN 1/35E-21 ethinyl estradiol; norethindrone TABLET;ORAL-21 071480-001 Apr 12, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Apil ESTROSTEP FE ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 020130-002 Oct 9, 1996 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

Expired US Patents for ethinyl estradiol; norethindrone

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Mallinckrodt
Medtronic
McKesson
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.