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Ethinyl Estradiol; Norethindrone Acetate Patent Expiration

Ethinyl Estradiol; Norethindrone Acetate is Used for preventing pregnancy in women using oral contraceptives. It was first introduced by Parke Davis Laboratories Div Warner Lambert Co in its drug Norlestrin 21 1/50 on Approved Prior to Jan 1, 1982. Other drugs containing Ethinyl Estradiol; Norethindrone Acetate are Norlestrin 28 1/50, Estrostep 21, Taytulla, Norlestrin 21 2.5/50, Loestrin Fe 1.5/30, Loestrin 24 Fe, Femlyv, Loestrin Fe 1/20, Loestrin 21 1/20, Loestrin 21 1.5/30, Lo Minastrin Fe, Femhrt, Lo Loestrin Fe, Minastrin 24 Fe, Estrostep Fe. 20 different companies have introduced drugs containing Ethinyl Estradiol; Norethindrone Acetate.


Ethinyl Estradiol; Norethindrone Acetate Patents

Given below is the list of patents protecting Ethinyl Estradiol; Norethindrone Acetate, 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
Femlyv US12178824 Orodispersible formulations Jun 24, 2041 Millicent Pr
Lo Loestrin Fe US7704984 Extended estrogen dosing contraceptive regimen Feb 02, 2029 Apil
Lo Minastrin Fe US7704984 Extended estrogen dosing contraceptive regimen Feb 02, 2029 Apil
Taytulla US6652880 Oral pharmaceutical compositions containing long-chain triglycerides and liphophilic surfactants Mar 29, 2020

(Expired)

 Apil
Lo Minastrin Fe US6667050 Chewable oral contraceptive Apr 06, 2019

(Expired)

 Apil
Minastrin 24 Fe US6667050 Chewable oral contraceptive Apr 06, 2019

(Expired)

 Apil
Loestrin 24 Fe US5552394 Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy Jul 22, 2014

(Expired)

 Teva Branded Pharm
Lo Loestrin Fe US5552394 Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy Jul 22, 2014

(Expired)

 Apil
Lo Minastrin Fe US5552394 Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy Jul 22, 2014

(Expired)

 Apil
Minastrin 24 Fe US5552394 Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy Jul 22, 2014

(Expired)

 Apil
Taytulla US5552394 Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy Jul 22, 2014

(Expired)

 Apil



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Ethinyl Estradiol; Norethindrone Acetate's patents.

Given below is the list recent legal activities going on the following patents of Ethinyl Estradiol; Norethindrone Acetate.

Activity Date Patent Number
Patent litigations
File Marked Found 05 Apr, 2017 US6652880
Recordation of Patent Grant Mailed
Critical
 25 Nov, 2003 US6652880
Patent Issue Date Used in PTA Calculation
Critical
 25 Nov, 2003 US6652880
Issue Notification Mailed
Critical
 06 Nov, 2003 US6652880
Receipt into Pubs 16 Oct, 2003 US6652880
Application Is Considered Ready for Issue
Critical
 13 Oct, 2003 US6652880
Receipt into Pubs 01 Oct, 2003 US6652880
Issue Fee Payment Received
Critical
 25 Aug, 2003 US6652880
Issue Fee Payment Verified
Critical
 25 Aug, 2003 US6652880
Receipt into Pubs 18 Aug, 2003 US6652880


Ethinyl Estradiol; Norethindrone Acetate's Family Patents

Family Patents

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Ethinyl Estradiol; Norethindrone Acetate Generic API Manufacturers

Several generic applications have been filed for Ethinyl Estradiol; Norethindrone Acetate. The first generic version for Ethinyl Estradiol; Norethindrone Acetate was by Dr Reddys Laboratories Sa and was approved on Feb 5, 2001. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Dec 6, 2023.

Given below is the list of companies who have filed for Ethinyl Estradiol; Norethindrone Acetate 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 Acetate. This 0.02mg;1mg version comes by the name NORETHINDRONE ACETATE 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
0.02MG; 1MG

capsule Discontinued ORAL N/A Jul 20, 2021





2. APOTEX

Apotex Inc has filed for 1 generic for Ethinyl Estradiol; Norethindrone Acetate. This 0.02mg;1mg version comes by the name NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.02MG; 1MG

tablet Discontinued ORAL N/A Mar 21, 2018


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Etobicoke Apotex, Inc.
Toronto Apotex Inc.
Brantford Apotex Pharmachem Inc.
Richmond Hill Apotex Inc.
Winnipeg Apotex Fermentation Inc.
North York Apotex Inc.
India
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited





3. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Ethinyl Estradiol; Norethindrone Acetate. Out of these 0.03mg;1.5mg version comes by the name AUROVELA 1.5/30, 0.02mg;1mg version comes by the name OSHIH. 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
0.03MG; 1.5MG

tablet Prescription ORAL-21 AB Jun 26, 2017
0.02MG; 1MG

tablet Discontinued ORAL N/A Dec 6, 2023


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





4. BARR

Barr Laboratories Inc has filed for 3 different strengths of generic version for Ethinyl Estradiol; Norethindrone Acetate. Out of these 0.03mg;1.5mg version comes by the name JUNEL FE 1.5/30, 0.02mg;1mg version comes by the name JUNEL FE 1/20, 0.02mg,0.03mg,0.035mg;1mg,1mg,1mg version comes by the name TRI-LEGEST FE. Given below are the details of the strengths of this generic introduced by Barr.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.03MG; 1.5MG

(reference standard)

tablet Prescription ORAL-28 AB Sep 18, 2003
0.02MG; 1MG

tablet Prescription ORAL-28 AB Sep 18, 2003
0.02MG,0.03MG,0.035MG; 1MG,1MG,1MG

tablet Prescription ORAL-28 AB Oct 26, 2007


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





5. BARR LABS

Barr Laboratories Llc (an Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc) has filed for 1 generic for Ethinyl Estradiol; Norethindrone Acetate. This 0.02mg;1mg version comes by the name NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE. 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
0.02MG; 1MG

tablet Prescription ORAL AB Dec 1, 2014





6. BARR LABS INC

Barr Laboratories Inc has filed for 1 generic for Ethinyl Estradiol; Norethindrone Acetate. This 0.005mg;1mg version comes by the name NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL. Given below are the details of the strengths of this generic introduced by Barr Labs Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.005MG; 1MG

(reference standard)

tablet Prescription ORAL AB Nov 6, 2009





7. DR REDDYS LABS SA

Dr Reddys Laboratories Sa has filed for 3 different strengths of generic version for Ethinyl Estradiol; Norethindrone Acetate. Out of these 0.02mg;1mg version comes by the name NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, 0.03mg;1.5mg version comes by the name MICROGESTIN 1.5/30, 0.02mg,0.03mg,0.035mg;1mg,1mg,1mg version comes by the name NORETHINDRONE ACETATE 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
0.02MG; 1MG

capsule Discontinued ORAL N/A Apr 28, 2022
0.03MG; 1.5MG

tablet Discontinued ORAL-21 N/A Jul 30, 2003
0.02MG,0.03MG,0.035MG; 1MG,1MG,1MG

tablet Discontinued ORAL-28 N/A Mar 18, 2010





8. ENDO OPERATIONS

Endo Operations Ltd has filed for 2 different strengths of generic version for Ethinyl Estradiol; Norethindrone Acetate. Out of these 0.03mg;1.5mg version comes by the name GILDESS 1.5/30, 0.02mg;1mg version comes by the name GILDESS 24 FE. 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
0.03MG; 1.5MG

tablet Discontinued ORAL-21 N/A Jul 24, 2012
0.02MG; 1MG

tablet Prescription ORAL AB Dec 1, 2014





9. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Ethinyl Estradiol; Norethindrone Acetate. Out of these 0.0025mg;0.5mg version comes by the name NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, 0.005mg;1mg version comes by the name NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, 0.02mg;1mg version comes by the name NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE. 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
0.0025MG; 0.5MG

tablet Prescription ORAL AB Apr 2, 2015
0.005MG; 1MG

tablet Prescription ORAL AB Apr 2, 2015
0.02MG; 1MG

capsule Prescription ORAL AB Jul 27, 2022





10. GLENMARK SPECLT

Glenmark Specialty Sa has filed for 1 generic for Ethinyl Estradiol; Norethindrone Acetate. This 0.03mg;1.5mg version comes by the name HAILEY 1.5/30. Given below are the details of the strengths of this generic introduced by Glenmark Speclt.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.03MG; 1.5MG

tablet Prescription ORAL-21 AB Jun 5, 2018





11. LUPIN

Lupin Inc has filed for 1 generic for Ethinyl Estradiol; Norethindrone Acetate. This 0.02mg;1mg version comes by the name MIBELAS 24 FE. Given below are the details of the strengths of this generic introduced by Lupin.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.02MG; 1MG

tablet Prescription ORAL AB May 24, 2016


Manufacturing Plant Locations
New

Lupin'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 Lupin as present at those locations.

Country City Firm Name
India
Nagpur Lupin Limited
Pune Lupin Bioresearch Center
Navi Mumbai LUPIN LIMITED
Tarapur, Thane Lupin Limited
Dabhasa LUPIN MANUFACTURING SOLUTIONS LIMITED
Mandideep Lupin Limited
Mandideep Lupin Limited (Unit II)
Pithampur Lupin Limited (Unit 1)
Anakapalli District Lupin Manufacturing Solutions Limited
Pithampur Lupin Limited
Aurangabad Lupin Ltd.
Vasco Da Gama Lupin Limited
Pirangut Lupin Limited
Mumbai Lupin Limited
United States
Coral Springs Lupin Research Inc
Baltimore Lupin Pharmaceuticals Inc.





12. LUPIN LTD

Lupin Ltd has filed for 4 different strengths of generic version for Ethinyl Estradiol; Norethindrone Acetate. Out of these 0.02mg;1mg version comes by the name BLISOVI FE 1/20, 0.03mg;1.5mg version comes by the name BLISOVI FE 1.5/30, 0.0025mg;0.5mg version comes by the name FYAVOLV, 0.005mg;1mg version comes by the name FYAVOLV. 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
0.02MG; 1MG

tablet Prescription ORAL-28 AB Nov 18, 2015
0.03MG; 1.5MG

tablet Prescription ORAL-28 AB Nov 18, 2015
0.0025MG; 0.5MG

tablet Prescription ORAL AB Dec 10, 2015
0.005MG; 1MG

tablet Prescription ORAL AB Dec 10, 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.





13. NOVAST LABS

Novast Laboratories Ltd has filed for 5 different strengths of generic version for Ethinyl Estradiol; Norethindrone Acetate. Out of these 0.03mg;1.5mg version comes by the name LARIN 1.5/30, 0.02mg;1mg version comes by the name LARIN 24 FE, 0.0025mg;0.5mg version comes by the name LERIBANE, 0.005mg;1mg version comes by the name LERIBANE, 0.02mg,0.03mg,0.035mg;1mg,1mg,1mg version comes by the name CHABELINA FE. Given below are the details of the strengths of this generic introduced by Novast Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.03MG; 1.5MG

tablet Prescription ORAL-21 AB Mar 20, 2014
0.02MG; 1MG

tablet Prescription ORAL AB Feb 18, 2015
0.0025MG; 0.5MG

tablet Prescription ORAL AB Jun 3, 2016
0.005MG; 1MG

tablet Prescription ORAL AB Jun 3, 2016
0.02MG,0.03MG,0.035MG; 1MG,1MG,1MG

(reference standard)

tablet Prescription ORAL-28 AB Apr 15, 2020





14. TEVA PHARMS USA INC

Teva Pharmaceuticals Usa Inc has filed for 1 generic for Ethinyl Estradiol; Norethindrone Acetate. This 0.02mg;1mg version comes by the name FINZALA. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.02MG; 1MG

tablet Prescription ORAL AB Apr 7, 2020





15. WILSHIRE PHARMS INC

Wilshire Pharmaceuticals Inc has filed for 1 generic for Ethinyl Estradiol; Norethindrone Acetate. This 0.02mg;1mg version comes by the name MERZEE. Given below are the details of the strengths of this generic introduced by Wilshire Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.02MG; 1MG

capsule Prescription ORAL AB Dec 18, 2020





16. XIROMED

Xiromed Pharma Espana Sl has filed for 6 different strengths of generic version for Ethinyl Estradiol; Norethindrone Acetate. Out of these 0.02mg;1mg version comes by the name GEMMILY, 0.03mg;1.5mg version comes by the name NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, 0.01mg,0.01mg;1mg,n/a version comes by the name NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, 0.005mg;1mg version comes by the name NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, 0.0025mg;0.5mg version comes by the name NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, 0.02mg,0.03mg,0.035mg;1mg,1mg,1mg version comes by the name NORETHINDRONE ACETATE 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
0.02MG; 1MG

capsule Prescription ORAL AB Nov 9, 2020
0.03MG; 1.5MG

tablet Prescription ORAL-28 AB Feb 20, 2015
0.01MG,0.01MG; 1MG,N/A

tablet Discontinued ORAL N/A May 31, 2016
0.005MG; 1MG

tablet Discontinued ORAL N/A Dec 27, 2016
0.0025MG; 0.5MG

tablet Discontinued ORAL N/A Feb 2, 2017
0.02MG,0.03MG,0.035MG; 1MG,1MG,1MG

tablet Prescription ORAL-28 AB Jun 22, 2018


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