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Ethinyl Estradiol; Norgestimate Patent Expiration

Ethinyl Estradiol; Norgestimate is Used for preventing pregnancy. It was first introduced by Janssen Pharmaceuticals Inc in its drug Ortho Cyclen-21 on Dec 29, 1989. Other drugs containing Ethinyl Estradiol; Norgestimate are Ortho Tri-Cyclen, Ortho Cyclen-28, Ortho Tri-Cyclen Lo. 17 different companies have introduced drugs containing Ethinyl Estradiol; Norgestimate.


Ethinyl Estradiol; Norgestimate Patents

Given below is the list of patents protecting Ethinyl Estradiol; Norgestimate, 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
Ortho Tri-cyclen Lo US6214815

(Pediatric)

 Triphasic oral contraceptive Dec 09, 2019

(Expired)

 Janssen Pharms
Ortho Tri-cyclen Lo US6214815 Triphasic oral contraceptive Jun 09, 2019

(Expired)

 Janssen Pharms



Ethinyl Estradiol; Norgestimate's Family Patents

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Ethinyl Estradiol; Norgestimate Generic API Manufacturers

Several generic applications have been filed for Ethinyl Estradiol; Norgestimate. The first generic version for Ethinyl Estradiol; Norgestimate was by Barr Laboratories Inc and was approved on Sep 25, 2002. And the latest generic version is by Novast Laboratories Ltd and was approved on Sep 2, 2022.

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


1. AMNEAL PHARMS

Amneal Pharmaceuticals Of New York Llc has filed for 3 different strengths of generic version for Ethinyl Estradiol; Norgestimate. All of these versions come by the name NORGESTIMATE AND ETHINYL ESTRADIOL. 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; 0.25MG

tablet Discontinued ORAL-28 N/A Oct 27, 2015
0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG

tablet Discontinued ORAL-28 N/A Nov 12, 2015
0.025MG,0.025MG,0.025MG; 0.18MG,0.215MG,0.25MG

tablet Prescription ORAL-28 AB May 12, 2016





2. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 1 generic for Ethinyl Estradiol; Norgestimate. This 0.025mg,0.025mg,0.025mg;0.18mg,0.215mg,0.25mg version comes by the name TRI-LO-MILI. 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
0.025MG,0.025MG,0.025MG; 0.18MG,0.215MG,0.25MG

tablet Prescription ORAL-28 AB Nov 4, 2016


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
Medchal Aurobindo Pharma Ltd
Sangareddy Aurobindo Pharma Limited
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





3. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Ethinyl Estradiol; Norgestimate. Out of these 0.035mg,0.035mg,0.035mg;0.18mg,0.215mg,0.25mg version comes by the name TRI-MILI, 0.035mg;0.25mg version comes by the name MILI. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG

tablet Prescription ORAL-28 AB Jul 6, 2016
0.035MG; 0.25MG

tablet Prescription ORAL-28 AB Jul 7, 2016


Manufacturing Plant Locations
New

Aurobindo Pharma 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 Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





4. BARR

Barr Laboratories Inc has filed for 2 different strengths of generic version for Ethinyl Estradiol; Norgestimate. Out of these 0.035mg;0.25mg version comes by the name SPRINTEC, 0.035mg,0.035mg,0.035mg;0.18mg,0.215mg,0.25mg version comes by the name TRI-SPRINTEC. 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; 0.25MG

(reference standard)

tablet Prescription ORAL-28 AB Sep 25, 2002
0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG

tablet Prescription ORAL-28 AB Dec 29, 2003


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





5. BARR LABS INC

Barr Laboratories Inc has filed for 1 generic for Ethinyl Estradiol; Norgestimate. This 0.025mg,0.025mg,0.025mg;0.18mg,0.215mg,0.25mg version comes by the name TRI LO SPRINTEC. 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
0.025MG,0.025MG,0.025MG; 0.18MG,0.215MG,0.25MG

tablet Prescription ORAL-28 AB Jun 29, 2009





6. ENDO OPERATIONS

Endo Operations Ltd has filed for 2 different strengths of generic version for Ethinyl Estradiol; Norgestimate. Out of these 0.035mg;0.25mg version comes by the name PREVIFEM, 0.035mg,0.035mg,0.035mg;0.18mg,0.215mg,0.25mg version comes by the name TRI-PREVIFEM. 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; 0.25MG

tablet Prescription ORAL-28 AB Jan 9, 2004
0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG

tablet Discontinued ORAL-28 N/A Mar 26, 2004





7. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Ethinyl Estradiol; Norgestimate. All of these versions come by the name NORGESTIMATE AND ETHINYL ESTRADIOL. 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,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG

(reference standard)

tablet Prescription ORAL-28 AB Jun 17, 2011
0.035MG; 0.25MG

tablet Prescription ORAL-28 AB Apr 5, 2012





8. GLENMARK SPECLT

Glenmark Specialty Sa has filed for 1 generic for Ethinyl Estradiol; Norgestimate. This 0.025mg,0.025mg,0.025mg;0.18mg,0.215mg,0.25mg version comes by the name NORGESTIMATE AND ETHINYL ESTRADIOL. 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
0.025MG,0.025MG,0.025MG; 0.18MG,0.215MG,0.25MG

(reference standard)

tablet Prescription ORAL-28 AB Feb 23, 2016





9. LUPIN LTD

Lupin Ltd has filed for 2 different strengths of generic version for Ethinyl Estradiol; Norgestimate. All of these versions come by the name NORGESTIMATE AND ETHINYL ESTRADIOL. 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; 0.18MG,0.215MG,0.25MG

tablet Prescription ORAL-28 AB Apr 26, 2016
0.035MG; 0.25MG

tablet Prescription ORAL-28 AB Oct 27, 2016


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. LUPIN PHARMS

Lupin Pharmaceuticals Inc has filed for 1 generic for Ethinyl Estradiol; Norgestimate. This 0.025mg,0.025mg,0.025mg;0.18mg,0.215mg,0.25mg version comes by the name NORGESTIMATE AND ETHINYL ESTRADIOL. Given below are the details of the strengths of this generic introduced by Lupin Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.025MG,0.025MG,0.025MG; 0.18MG,0.215MG,0.25MG

tablet Prescription ORAL-28 AB Jun 25, 2012





11. MYLAN

Mylan Laboratories Ltd A Viatris Co has filed for 1 generic for Ethinyl Estradiol; Norgestimate. This 0.035mg;0.25mg version comes by the name NORGESTIMATE AND ETHINYL ESTRADIOL. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.035MG; 0.25MG

tablet Discontinued ORAL-28 N/A Jan 27, 2016


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Rockford Mylan Institutional, Inc.
Morgantown Mylan Specialty, L.P.
San Carlos Mylan Pharmaceuticals Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Greensboro Mylan Pharmaceuticals Inc
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Saint Albans Mylan Technologies, Inc.
India
Anekal Taluk, Bangalore Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Hyderabad Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





12. NAARI PTE LTD

Naari Pte Ltd has filed for 2 different strengths of generic version for Ethinyl Estradiol; Norgestimate. All of these versions come by the name NORGESTIMATE 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,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG

tablet Prescription ORAL-28 AB Apr 7, 2015
0.035MG; 0.25MG

tablet Prescription ORAL-28 AB Apr 7, 2015





13. NOVAST LABS

Novast Laboratories Ltd has filed for 1 generic for Ethinyl Estradiol; Norgestimate. This 0.025mg,0.025mg,0.025mg;0.18mg,0.215mg,0.25mg version comes by the name TRI-LO-LINYAH. 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
0.025MG,0.025MG,0.025MG; 0.18MG,0.215MG,0.25MG

tablet Prescription ORAL-28 AB Sep 2, 2022





14. NOVAST LABS LTD

Novast Laboratories Ltd has filed for 2 different strengths of generic version for Ethinyl Estradiol; Norgestimate. Out of these 0.035mg;0.25mg version comes by the name MONO-LINYAH, 0.035mg,0.035mg,0.035mg;0.18mg,0.215mg,0.25mg version comes by the name TRI-LINYAH. 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; 0.25MG

tablet Prescription ORAL-28 AB May 23, 2012
0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG

tablet Prescription ORAL-28 AB May 30, 2012





15. WATSON LABS

Watson Laboratories Inc has filed for 3 different strengths of generic version for Ethinyl Estradiol; Norgestimate. All of these versions come by the name NORGESTIMATE 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,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG

tablet Discontinued ORAL-28 N/A Aug 17, 2006
0.035MG; 0.25MG

tablet Discontinued ORAL-28 N/A Aug 17, 2006
0.025MG,0.025MG,0.025MG; 0.18MG,0.215MG,0.25MG

tablet Discontinued ORAL-28 N/A Mar 9, 2011





16. XIROMED

Xiromed Llc has filed for 3 different strengths of generic version for Ethinyl Estradiol; Norgestimate. Out of these 0.035mg,0.035mg,0.035mg;0.18mg,0.215mg,0.25mg version comes by the name NORGESTIMATE AND ETHINYL ESTRADIOL, 0.035mg;0.25mg version comes by the name ESTARYLLA, 0.025mg,0.025mg,0.025mg;0.18mg,0.215mg,0.25mg version comes by the name NORGESTIMATE 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
0.035MG,0.035MG,0.035MG; 0.18MG,0.215MG,0.25MG

tablet Discontinued ORAL-28 N/A Jan 27, 2016
0.035MG; 0.25MG

tablet Prescription ORAL-28 AB Jan 30, 2013
0.025MG,0.025MG,0.025MG; 0.18MG,0.215MG,0.25MG

tablet Discontinued ORAL-28 N/A Sep 9, 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