Drug Patent List
Litigation OpportunitiesNew
Newsletter
Weekly Digest

Pharsight

Ethinyl Estradiol; Norethindrone Patent Expiration

Ethinyl Estradiol; Norethindrone is Used for preventing pregnancy in women using oral contraceptives. It was first introduced by Ortho Mcneil Pharmaceutical Inc in its drug Modicon 21 on Approved Prior to Jan 1, 1982. Other drugs containing Ethinyl Estradiol; Norethindrone are Norethindrone And Ethinyl Estradiol And Ferrous Fumarate, Tri-Norinyl 28-Day, Ortho-Novum 1/35-21, Ortho-Novum 7/14-28, Ortho-Novum 1/35-28, Tri-Norinyl 21-Day, Brevicon 28-Day, Brevicon 21-Day, Ortho-Novum 7/14-21, Ovcon-50, Ortho-Novum 7/7/7-21, Ortho-Novum 10/11-28, Modicon 28, Ortho-Novum 10/11-21, Norinyl 1+35 21-Day, Ortho-Novum 7/7/7-28, Ovcon-35, Femcon Fe, Norinyl 1+35 28-Day. 24 different companies have introduced drugs containing Ethinyl Estradiol; Norethindrone.


Ethinyl Estradiol; Norethindrone Patents

Given below is the list of patents protecting Ethinyl Estradiol; Norethindrone, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Femcon Fe US6667050 Chewable oral contraceptive Apr 06, 2019

(Expired)

 Apil
Norethindrone And Ethinyl Estradiol And Ferrous Fumarate US6667050 Chewable oral contraceptive Apr 06, 2019

(Expired)

 Teva Branded Pharm
Norethindrone And Ethinyl Estradiol And Ferrous Fumarate US5552394 Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy Jul 22, 2014

(Expired)

 Teva Branded Pharm



Ethinyl Estradiol; Norethindrone's Family Patents

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List

Ethinyl Estradiol; Norethindrone Generic API Manufacturers

Several generic applications have been filed for Ethinyl Estradiol; Norethindrone. The first generic version for Ethinyl Estradiol; Norethindrone was by Watson Pharmaceuticals Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc and was approved on Jan 29, 1987. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Oct 11, 2022.

Given below is the list of companies who have filed for Ethinyl Estradiol; Norethindrone generic, along with the locations of their manufacturing plants worldwide.


1. AMNEAL PHARMS

Amneal Pharmaceuticals Of New York Llc has filed for 1 generic for Ethinyl Estradiol; Norethindrone. This 0.035mg;0.4mg version comes by the name NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG; 0.4MG

tablet Prescription ORAL AB Sep 26, 2011





2. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 4 different strengths of generic version for Ethinyl Estradiol; Norethindrone. Out of these 0.035mg;0.5mg version comes by the name CYONANZ, 0.035mg;1mg version comes by the name NYLIA 1/35, 0.035mg,0.035mg,0.035mg;0.5mg,0.75mg,1mg version comes by the name NYLIA 7/7/7, 0.035mg;0.4mg version comes by the name RHUZDAH. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG; 0.5MG

tablet Prescription ORAL-28 AB Oct 21, 2016
0.035MG; 1MG

tablet Prescription ORAL-28 AB Oct 21, 2016
0.035MG,0.035MG,0.035MG; 0.5MG,0.75MG,1MG

tablet Prescription ORAL-28 AB Oct 21, 2016
0.035MG; 0.4MG

tablet Discontinued ORAL-28 N/A Oct 11, 2022


Manufacturing Plant Locations
New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Bachupally Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Sangareddy Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





3. BARR

Barr Laboratories Inc has filed for 6 different strengths of generic version for Ethinyl Estradiol; Norethindrone. Out of these 0.035mg;0.5mg version comes by the name NORTREL 0.5/35-21, 0.035mg;1mg version comes by the name NORTREL 1/35-21, 0.035mg,0.035mg;0.5mg,1mg version comes by the name GENCEPT 10/11-21, 0.035mg,0.035mg,0.035mg;0.5mg,0.75mg,1mg version comes by the name NORTREL 7/7/7, 0.035mg;0.4mg version comes by the name NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, 0.035mg,0.035mg,0.035mg;0.5mg,1mg,0.5mg version comes by the name ARANELLE. Given below are the details of the strengths of this generic introduced by Barr.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG; 0.5MG

tablet Discontinued ORAL-21 N/A Feb 28, 1992
0.035MG; 1MG

tablet Prescription ORAL-21 AB Feb 28, 1992
0.035MG,0.035MG; 0.5MG,1MG

tablet Discontinued ORAL-21 N/A Feb 28, 1992
0.035MG,0.035MG,0.035MG; 0.5MG,0.75MG,1MG

tablet Prescription ORAL-28 AB Aug 30, 2002
0.035MG; 0.4MG

tablet Prescription ORAL AB Aug 5, 2010
0.035MG,0.035MG,0.035MG; 0.5MG,1MG,0.5MG

tablet Prescription ORAL-28 AB Sep 29, 2004


Manufacturing Plant Locations
New

Barr's manufacturing plants are situated in 4 countries - Mexico, Singapore, United States, Philippines. Given below are the details of these plant locations as well as the firm names of Barr as present at those locations.

Country City Firm Name
Mexico
Aldama Barra La Coma, S. De R.L
Singapore
Singapore Barramundi Asia Pte Ltd
United States
Brainerd Barrett Ag Service, Inc.
Commerce Barreras Meat Co
Live Oak Barrington Dairy Farm
Forest Barr Laboratories Inc.
Belvidere Barred Woods, LLC
Lake Barrington Barrington Ventures, Ltd
Hereford Barrett and Crofoot, LLP
Arecibo Barreto Dairy, Inc.
Lee Barrington Coffee Roasting Company, Inc.
Swartz Creek Barrett Donut Mixes, Inc..
Davie Barrier Technologies LLC
Englewood Barrett E. Cowan, MD
Machipongo Barrier Island Seafood
Dillon Barretts Minerals Inc
Madison Barriques Holding Company, LLC
Randolph Barrett Farm
Memphis Barrett Distribution Centers
Montezuma Barrington Dairies
Paso Robles Barreto Cellars
Newton Barrett Technology, LLC
Hereford Barrett and Crofoot Feedyard, West
Harrison Barrington Chemical Corporation
Curtis Bay Barrett Distribution Center
Barrett Barrett Farm Supply, Inc.
Somerset Barrett Distribution Centers Inc
Greenwood Barr Enterprises, Inc.
Buffalo Barrel and Brine Inc
Franklin Barrett Distribution Centers, Inc.
Philippines
Bulacan Barrio Fiesta Manufacturing Corporation





4. BARR LABS

Barr Laboratories Llc (an Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc) has filed for 3 different strengths of generic version for Ethinyl Estradiol; Norethindrone. Out of these 0.035mg,0.035mg;0.5mg,1mg version comes by the name GENCEPT 10/11-28, 0.035mg;0.5mg version comes by the name NORTREL 0.5/35-28, 0.035mg;1mg version comes by the name NORTREL 1/35-28. Given below are the details of the strengths of this generic introduced by Barr Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG,0.035MG; 0.5MG,1MG

tablet Discontinued ORAL-28 N/A Feb 28, 1992
0.035MG; 0.5MG

tablet Prescription ORAL-28 AB Feb 28, 1992
0.035MG; 1MG

(reference standard)

tablet Prescription ORAL-28 AB Feb 28, 1992





5. DR REDDYS LABS SA

Dr Reddys Laboratories Sa has filed for 1 generic for Ethinyl Estradiol; Norethindrone. This 0.035mg;0.5mg version comes by the name NORETHINDRONE AND ETHINYL ESTRADIOL. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG; 0.5MG

tablet Discontinued ORAL-28 N/A Jan 29, 1987





6. ENDO OPERATIONS

Endo Operations Ltd has filed for 4 different strengths of generic version for Ethinyl Estradiol; Norethindrone. Out of these 0.035mg;1mg version comes by the name CYCLAFEM 1/35, 0.035mg,0.035mg,0.035mg;0.5mg,0.75mg,1mg version comes by the name CYCLAFEM 7/7/7, 0.035mg;0.4mg version comes by the name GILDAGIA, 0.035mg;0.5mg version comes by the name CYCLAFEM 0.5/35. Given below are the details of the strengths of this generic introduced by Endo Operations.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG; 1MG

tablet Discontinued ORAL-28 N/A Nov 12, 2010
0.035MG,0.035MG,0.035MG; 0.5MG,0.75MG,1MG

tablet Discontinued ORAL-28 N/A Nov 16, 2010
0.035MG; 0.4MG

tablet Prescription ORAL-28 AB Nov 6, 2012
0.035MG; 0.5MG

tablet Discontinued ORAL-28 N/A Dec 16, 2015





7. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Ethinyl Estradiol; Norethindrone. Out of these 0.035mg;0.4mg version comes by the name BRIELLYN, 0.035mg;1mg version comes by the name ALYACEN 1/35, 0.035mg,0.035mg,0.035mg;0.5mg,0.75mg,1mg version comes by the name ALYACEN 7/7/7. Given below are the details of the strengths of this generic introduced by Glenmark Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG; 0.4MG

tablet Prescription ORAL-28 AB Mar 22, 2011
0.035MG; 1MG

tablet Prescription ORAL-28 AB Jan 19, 2012
0.035MG,0.035MG,0.035MG; 0.5MG,0.75MG,1MG

tablet Prescription ORAL-28 AB Jan 19, 2012





8. LPI

Lpi Holdings Inc has filed for 1 generic for Ethinyl Estradiol; Norethindrone. This 0.035mg;1mg version comes by the name N.E.E. 1/35 21. Given below are the details of the strengths of this generic introduced by Lpi.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG; 1MG

tablet Discontinued ORAL-21 N/A Dec 14, 1987





9. LUPIN LTD

Lupin Ltd has filed for 4 different strengths of generic version for Ethinyl Estradiol; Norethindrone. Out of these 0.035mg,0.035mg,0.035mg;0.5mg,0.75mg,1mg version comes by the name PIRMELLA 7/7/7, 0.035mg;1mg version comes by the name PIRMELLA 1/35, 0.035mg;0.4mg version comes by the name NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, 0.025mg;0.8mg version comes by the name KAITLIB FE. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG,0.035MG,0.035MG; 0.5MG,0.75MG,1MG

tablet Discontinued ORAL-28 N/A Apr 24, 2013
0.035MG; 1MG

tablet Discontinued ORAL-28 N/A Apr 24, 2013
0.035MG; 0.4MG

tablet Prescription ORAL AB Mar 23, 2016
0.025MG; 0.8MG

(reference standard)

tablet, chewable Prescription ORAL AB Dec 17, 2015


Manufacturing Plant Locations
New

Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





10. MYLAN LABS LTD

Mylan Laboratories Ltd has filed for 3 different strengths of generic version for Ethinyl Estradiol; Norethindrone. All of these versions come by the name NORETHINDRONE AND ETHINYL ESTRADIOL. Given below are the details of the strengths of this generic introduced by Mylan Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG; 0.5MG

tablet Discontinued ORAL-28 N/A Oct 21, 2015
0.035MG; 1MG

tablet Discontinued ORAL-28 N/A Oct 21, 2015
0.035MG,0.035MG,0.035MG; 0.5MG,0.75MG,1MG

tablet Discontinued ORAL-28 N/A Dec 28, 2015





11. NAARI PTE LTD

Naari Pte Ltd has filed for 2 different strengths of generic version for Ethinyl Estradiol; Norethindrone. Out of these 0.035mg;0.4mg version comes by the name NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, 0.035mg;1mg version comes by the name NORETHINDRONE AND ETHINYL ESTRADIOL. Given below are the details of the strengths of this generic introduced by Naari Pte Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG; 0.4MG

tablet Prescription ORAL AB Mar 29, 2017
0.035MG; 1MG

tablet Prescription ORAL-28 AB Apr 28, 2017





12. NOVAST LABS LTD

Novast Laboratories Ltd has filed for 4 different strengths of generic version for Ethinyl Estradiol; Norethindrone. Out of these 0.035mg;0.4mg version comes by the name PHILITH, 0.035mg,0.035mg,0.035mg;0.5mg,0.75mg,1mg version comes by the name DASETTA 7/7/7, 0.035mg;1mg version comes by the name DASETTA 1/35, 0.035mg;0.5mg version comes by the name WERA. Given below are the details of the strengths of this generic introduced by Novast Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG; 0.4MG

tablet Prescription ORAL-28 AB Dec 22, 2011
0.035MG,0.035MG,0.035MG; 0.5MG,0.75MG,1MG

(reference standard)

tablet Prescription ORAL-28 AB Dec 22, 2011
0.035MG; 1MG

tablet Prescription ORAL-28 AB Dec 22, 2011
0.035MG; 0.5MG

(reference standard)

tablet Prescription ORAL-28 AB Mar 27, 2012





13. ORTHO MCNEIL PHARM

Ortho Mcneil Pharmaceutical Inc has filed for 1 generic for Ethinyl Estradiol; Norethindrone. This 0.035mg;1mg version comes by the name NORCEPT-E 1/35 21. Given below are the details of the strengths of this generic introduced by Ortho Mcneil Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG; 1MG

tablet Discontinued ORAL-21 N/A Feb 9, 1989





14. WATSON LABS

Watson Laboratories Inc has filed for 5 different strengths of generic version for Ethinyl Estradiol; Norethindrone. Out of these 0.035mg;0.5mg version comes by the name NORETHINDRONE AND ETHINYL ESTRADIOL, 0.035mg,0.035mg;0.5mg,1mg version comes by the name NORETHINDRONE AND ETHINYL ESTRADIOL (7/14), 0.035mg;1mg version comes by the name NORETHIN 1/35E-28, 0.035mg;0.4mg version comes by the name NORETHINDRONE AND ETHINYL ESTRADIOL, 0.035mg,0.035mg,0.035mg;0.5mg,0.75mg,1mg version comes by the name NORETHINDRONE AND ETHINYL ESTRADIOL. Given below are the details of the strengths of this generic introduced by Watson Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG; 0.5MG

tablet Discontinued ORAL-21 N/A Jan 29, 1987
0.035MG,0.035MG; 0.5MG,1MG

tablet Discontinued ORAL-28 N/A Sep 24, 1991
0.035MG; 1MG

tablet Discontinued ORAL-28 N/A Apr 12, 1988
0.035MG; 0.4MG

tablet Discontinued ORAL-21 N/A Feb 23, 2010
0.035MG,0.035MG,0.035MG; 0.5MG,0.75MG,1MG

tablet Discontinued ORAL-28 N/A Feb 4, 2010





15. WATSON LABS TEVA

Watson Laboratories Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Ethinyl Estradiol; Norethindrone. Out of these 0.035mg;1mg version comes by the name NORETHINDRONE AND ETHINYL ESTRADIOL, 0.035mg,0.035mg;0.5mg,1mg version comes by the name NORETHINDRONE AND ETHINYL ESTRADIOL (7/14). Given below are the details of the strengths of this generic introduced by Watson Labs Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG; 1MG

tablet Prescription ORAL-28 AB Jan 29, 1987
0.035MG,0.035MG; 0.5MG,1MG

tablet Discontinued ORAL-21 N/A Sep 24, 1991





16. WATSON PHARMS TEVA

Watson Pharmaceuticals Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 1 generic for Ethinyl Estradiol; Norethindrone. This 0.035mg;1mg version comes by the name NORETHIN 1/35E-21. Given below are the details of the strengths of this generic introduced by Watson Pharms Teva.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG; 1MG

tablet Discontinued ORAL-21 N/A Apr 12, 1988





17. XIROMED

Xiromed Llc has filed for 3 different strengths of generic version for Ethinyl Estradiol; Norethindrone. Out of these 0.05mg;1mg version comes by the name NORETHINDRONE AND ETHINYL ESTRADIOL, 0.025mg;0.8mg version comes by the name NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, 0.035mg;0.4mg version comes by the name NORETHINDRONE AND ETHINYL ESTRADIOL. Given below are the details of the strengths of this generic introduced by Xiromed.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05MG; 1MG

tablet Discontinued ORAL-28 N/A Aug 5, 2013
0.025MG; 0.8MG

tablet, chewable Prescription ORAL AB Apr 23, 2014
0.035MG; 0.4MG

tablet Discontinued ORAL-28 N/A May 11, 2015


Manufacturing Plant Locations
New

Xiromed's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Xiromed as present at those locations.

Country City Firm Name
United States
Florham Park XIROMED LLC