Ethinyl Estradiol; Levonorgestrel Patent Expiration

Ethinyl Estradiol; Levonorgestrel is Used for preventing pregnancy in women using oral contraceptives. It was first introduced by Teva Branded Pharmaceutical Products R And D Inc in its drug Nordette-21 on May 10, 1982. Other drugs containing Ethinyl Estradiol; Levonorgestrel are Lybrel, Tyblume, Nordette-28, Seasonale, Alesse, Loseasonique, Twirla, Preven Emergency Contraceptive Kit, Triphasil-21, Seasonique, Quartette, Triphasil-28, Levlite, Balcoltra. 24 different companies have introduced drugs containing Ethinyl Estradiol; Levonorgestrel.


Ethinyl Estradiol; Levonorgestrel Patents

Given below is the list of patents protecting Ethinyl Estradiol; Levonorgestrel, 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
Balcoltra US6716814 Enhancing solubility of iron amino acid chelates and iron proteinates Aug 16, 2021

(Expired)

Avion Pharms
Balcoltra US7838042 Hypoallergenic metal amino acid chelates and metal amino acid chelate-containing compositions Jun 01, 2027 Avion Pharms
Loseasonique US7615545 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology Jun 15, 2023

(Expired)

Teva Branded Pharm
Loseasonique US7855190 Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration Dec 05, 2028 Teva Branded Pharm
Loseasonique US7858605 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology Jun 23, 2023

(Expired)

Teva Branded Pharm
Lybrel US6500814 Hormonal contraceptive Sep 03, 2018

(Expired)

Wyeth Pharms Inc
Preven Emergency Contraceptive Kit US6156742 Emergency contraceptive kit Dec 05, 2020

(Expired)

Teva Branded Pharm
Quartette US8415332 Methods of hormonal treatment utilizing ascending-dose extended cycle regimens Mar 11, 2029 Teva Branded Pharm
Quartette US8450299 Methods of hormonal treatment utilizing ascending-dose extended cycle regimens Oct 07, 2025 Teva Branded Pharm
Seasonale US5898032 Ultra low dose oral contraceptives with less menstrual bleeding and sustained efficacy Jun 23, 2017

(Expired)

Teva Branded Pharm
Seasonale USRE39861 Methods of extended use oral contraception Jun 23, 2017

(Expired)

Teva Branded Pharm
Seasonique US7320969 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology Jan 30, 2024

(Expired)

Teva Branded Pharm
Seasonique US7615545 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology Jun 15, 2023

(Expired)

Teva Branded Pharm
Seasonique US7855190 Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration Dec 05, 2028 Teva Branded Pharm
Seasonique US7858605 Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology Jun 23, 2023

(Expired)

Teva Branded Pharm
Twirla US7045145 Transdermal contraceptive delivery system and process Mar 14, 2021

(Expired)

Agile
Twirla US7384650 Skin permeation enhancement composition for transdermal hormone delivery system Mar 14, 2021

(Expired)

Agile
Twirla US8221784 Transdermal hormone delivery system: compositions and methods Mar 14, 2021

(Expired)

Agile
Twirla US8221785 Transdermal hormone delivery system: compositions and methods Mar 14, 2021

(Expired)

Agile
Twirla US8246978 Dermal delivery device with reduced loss of its volatile components Aug 26, 2028 Agile
Twirla US8747888 Dermal delivery device with in situ seal Jul 10, 2028 Agile
Twirla US8883196 Transdermal hormone delivery system: compositions and methods Nov 22, 2020

(Expired)

Agile
Twirla US9050348 Dermal delivery device Jul 10, 2028 Agile


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; Levonorgestrel's patents.

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

Event Date Patent/Publication
Patent litigations
Maintenance Fee Reminder Mailed 04 Mar, 2024 US8221785
Maintenance Fee Reminder Mailed 04 Mar, 2024 US8221784
Payment of Maintenance Fee, 12th Yr, Small Entity 21 Feb, 2024 US8246978
Expire Patent 19 Dec, 2022 US8883196
Payment of Maintenance Fee, 8th Yr, Small Entity 09 Dec, 2022 US9050348
Maintenance Fee Reminder Mailed 04 Jul, 2022 US8883196
Payment of Maintenance Fee, 8th Year, Large Entity 18 Nov, 2020 US8450299(Litigated)
Payment of Maintenance Fee, 8th Year, Large Entity 05 Oct, 2020 US8415332(Litigated)
Payment of Maintenance Fee, 8th Yr, Small Entity 21 Feb, 2020 US8246978
Payment of Maintenance Fee, 8th Yr, Small Entity 17 Jan, 2020 US8221784



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Ethinyl Estradiol; Levonorgestrel Generics

Several generic applications have been filed for Ethinyl Estradiol; Levonorgestrel. The first generic version for Ethinyl Estradiol; Levonorgestrel was by Watson Laboratories Inc and was approved on Dec 13, 1993. And the latest generic version is by Lupin Ltd and was approved on Feb 15, 2024.

Given below is the list of companies who have filed for Ethinyl Estradiol; Levonorgestrel generic.


1. HETERO LABS

Hetero Labs Ltd has filed for 1 generic for Ethinyl Estradiol; Levonorgestrel. This 0.02mg;0.1mg version comes by the name LEVONORGESTREL AND ETHINYL ESTRADIOL. Given below are the details of the strengths of this generic introduced by Hetero Labs.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.02MG; 0.1MG tablet Prescription ORAL-28 AB1 Feb 13, 2023


2. WATSON LABS

Watson Laboratories Inc has filed for 2 different strengths of generic version for Ethinyl Estradiol; Levonorgestrel. Out of these 0.03mg;0.15mg version comes by the name QUASENSE, 0.02mg;0.09mg version comes by the name LEVONORGESTREL 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
0.03MG; 0.15MG tablet Prescription ORAL AB Sep 6, 2006
0.02MG; 0.09MG

(reference standard)

tablet Prescription ORAL AB Jun 6, 2011


3. XIROMED

Xiromed Pharma Espana Sl has filed for 6 different strengths of generic version for Ethinyl Estradiol; Levonorgestrel. Out of these 0.03mg;0.15mg version comes by the name LEVONORGESTREL AND ETHINYL ESTRADIOL, 0.02mg;0.1mg version comes by the name LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, 0.03mg,0.01mg;0.15mg,n/a version comes by the name JAIMIESS, 0.02mg,0.1mg;0.01mg,n/a version comes by the name LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, 0.03mg,0.04mg,0.03mg;0.05mg,0.075mg,0.125mg version comes by the name LEVONORGESTREL AND ETHINYL ESTRADIOL, 0.02mg,0.15mg;0.025mg,0.15mg;0.03mg,0.15mg;0.01mg,n/a version comes by the name LEVONORGESTREL AND ETHINYL ESTRADIOL 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
0.03MG; 0.15MG tablet Prescription ORAL AB Apr 21, 2015
0.02MG; 0.1MG tablet Prescription ORAL AB3 Aug 16, 2023
0.03MG,0.01MG; 0.15MG,N/A tablet Prescription ORAL AB Dec 27, 2017
0.02MG,0.1MG; 0.01MG,N/A tablet Prescription ORAL AB Dec 14, 2017
0.03MG,0.04MG,0.03MG; 0.05MG,0.075MG,0.125MG tablet Discontinued ORAL-28 N/A Mar 23, 2018
0.02MG,0.15MG; 0.025MG,0.15MG; 0.03MG,0.15MG; 0.01MG,N/A tablet Prescription ORAL AB Oct 2, 2017


4. LUPIN LTD

Lupin Ltd has filed for 6 different strengths of generic version for Ethinyl Estradiol; Levonorgestrel. Out of these 0.02mg,0.1mg;0.01mg,n/a version comes by the name LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, 0.03mg;0.15mg version comes by the name LEVONORGESTREL AND ETHINYL ESTRADIOL, 0.02mg;0.1mg version comes by the name MINZOYA, 0.03mg,0.01mg;0.15mg,n/a version comes by the name DAYSEE, 0.03mg,0.04mg,0.03mg;0.05mg,0.075mg,0.125mg version comes by the name LEVONORGESTREL AND ETHINYL ESTRADIOL, 0.02mg,0.15mg;0.025mg,0.15mg;0.03mg,0.15mg;0.01mg,n/a version comes by the name FAYOSIM. 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,0.1MG; 0.01MG,N/A tablet Prescription ORAL AB Oct 26, 2011
0.03MG; 0.15MG tablet Prescription ORAL AB Oct 23, 2012
0.02MG; 0.1MG tablet Prescription ORAL AB3 Feb 15, 2024
0.03MG,0.01MG; 0.15MG,N/A tablet Prescription ORAL AB Apr 10, 2013
0.03MG,0.04MG,0.03MG; 0.05MG,0.075MG,0.125MG tablet Prescription ORAL-28 AB Nov 19, 2015
0.02MG,0.15MG; 0.025MG,0.15MG; 0.03MG,0.15MG; 0.01MG,N/A tablet Discontinued ORAL N/A Mar 29, 2016


5. BARR

Barr Laboratories Inc has filed for 2 different strengths of generic version for Ethinyl Estradiol; Levonorgestrel. Out of these 0.02mg;0.1mg version comes by the name LEVONORGESTREL AND ETHINYL ESTRADIOL, 0.03mg;0.15mg version comes by the name PORTIA-21. Given below are the details of the strengths of this generic introduced by Barr.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.02MG; 0.1MG tablet Discontinued ORAL-21 N/A Apr 29, 2003
0.03MG; 0.15MG tablet Discontinued ORAL-21 N/A May 23, 2002


6. DURAMED PHARMS BARR

Duramed Pharmaceuticals Inc Sub Barr Laboratories Inc has filed for 2 different strengths of generic version for Ethinyl Estradiol; Levonorgestrel. Out of these 0.02mg;0.1mg version comes by the name AVIANE-28, 0.03mg,0.04mg,0.03mg;0.05mg,0.075mg,0.125mg version comes by the name ENPRESSE-28. Given below are the details of the strengths of this generic introduced by Duramed Pharms Barr.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.02MG; 0.1MG tablet Prescription ORAL-28 AB1 Apr 30, 2001
0.03MG,0.04MG,0.03MG; 0.05MG,0.075MG,0.125MG tablet Prescription ORAL-28 AB Jul 16, 2001


7. GLENMARK PHARMS LTD

Glenmark Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Ethinyl Estradiol; Levonorgestrel. Out of these 0.03mg;0.15mg version comes by the name LEVONORGESTREL AND ETHINYL ESTRADIOL, 0.03mg,0.01mg;0.15mg,n/a version comes by the name ASHLYNA, 0.02mg;0.09mg version comes by the name LEVONORGESTREL 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
0.03MG; 0.15MG tablet Prescription ORAL AB Jun 12, 2015
0.03MG,0.01MG; 0.15MG,N/A tablet Prescription ORAL AB Feb 23, 2015
0.02MG; 0.09MG tablet Prescription ORAL AB Apr 9, 2015


8. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 1 generic for Ethinyl Estradiol; Levonorgestrel. This 0.03mg;0.15mg version comes by the name ICLEVIA. 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
0.03MG; 0.15MG tablet Prescription ORAL AB Jun 29, 2018


9. AMNEAL PHARMS

Amneal Pharmaceuticals Of New York Llc has filed for 3 different strengths of generic version for Ethinyl Estradiol; Levonorgestrel. All of these versions come by the name LEVONORGESTREL 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
0.02MG; 0.1MG tablet Discontinued ORAL-28 N/A Feb 5, 2014
0.03MG; 0.15MG tablet Prescription ORAL AB Nov 13, 2015
0.03MG,0.01MG; 0.15MG,N/A tablet Prescription ORAL AB Dec 22, 2015


10. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Ethinyl Estradiol; Levonorgestrel. Out of these 0.02mg;0.1mg version comes by the name CERINTA, 0.03mg;0.15mg version comes by the name SYLEVIA. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.02MG; 0.1MG tablet Discontinued ORAL-28 N/A Jan 7, 2019
0.03MG; 0.15MG tablet Discontinued ORAL N/A Feb 6, 2019


11. NAARI PTE LTD

Naari Pte Ltd has filed for 2 different strengths of generic version for Ethinyl Estradiol; Levonorgestrel. All of these versions come by the name LEVONORGESTREL 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
0.02MG; 0.1MG tablet Prescription ORAL-28 AB1 Aug 17, 2020
0.03MG; 0.15MG tablet Prescription ORAL-28 AB Oct 9, 2020


12. ENDO OPERATIONS

Endo Operations Ltd has filed for 2 different strengths of generic version for Ethinyl Estradiol; Levonorgestrel. Out of these 0.02mg;0.1mg version comes by the name ORSYTHIA, 0.03mg,0.04mg,0.03mg;0.05mg,0.075mg,0.125mg version comes by the name MYZILRA. 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
0.02MG; 0.1MG tablet Discontinued ORAL-28 N/A May 11, 2011
0.03MG,0.04MG,0.03MG; 0.05MG,0.075MG,0.125MG tablet Prescription ORAL-28 AB Nov 23, 2011


13. NOVAST LABS

Novast Laboratories Ltd has filed for 2 different strengths of generic version for Ethinyl Estradiol; Levonorgestrel. Out of these 0.03mg;0.15mg version comes by the name SETLAKIN, 0.02mg;0.09mg version comes by the name DOLISHALE. 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; 0.15MG tablet Prescription ORAL AB Sep 15, 2014
0.02MG; 0.09MG tablet Prescription ORAL AB Oct 22, 2020


14. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 4 different strengths of generic version for Ethinyl Estradiol; Levonorgestrel. Out of these 0.03mg;0.15mg version comes by the name AYUNA, 0.02mg;0.1mg version comes by the name AFIRMELLE, 0.03mg,0.01mg;0.15mg,n/a version comes by the name SIMPESSE, 0.02mg,0.1mg;0.01mg,n/a version comes by the name LO SIMPESSE. 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; 0.15MG tablet Prescription ORAL-28 AB Sep 23, 2016
0.02MG; 0.1MG tablet Prescription ORAL-28 AB1 Nov 14, 2016
0.03MG,0.01MG; 0.15MG,N/A tablet Prescription ORAL AB Apr 7, 2017
0.02MG,0.1MG; 0.01MG,N/A tablet Prescription ORAL AB Apr 28, 2017


15. NOVAST LABS LTD

Novast Laboratories Ltd has filed for 2 different strengths of generic version for Ethinyl Estradiol; Levonorgestrel. Out of these 0.03mg,0.04mg,0.03mg;0.05mg,0.075mg,0.125mg version comes by the name LEVONEST, 0.02mg;0.1mg version comes by the name FALMINA. 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
0.03MG,0.04MG,0.03MG; 0.05MG,0.075MG,0.125MG tablet Prescription ORAL-28 AB Dec 29, 2010
0.02MG; 0.1MG tablet Prescription ORAL-28 AB1 Mar 28, 2012


16. DR REDDYS LABS SA

Dr Reddys Laboratories Sa has filed for 5 different strengths of generic version for Ethinyl Estradiol; Levonorgestrel. Out of these 0.03mg;0.15mg version comes by the name LEVORA 0.15/30-28, 0.03mg,0.04mg,0.03mg;0.05mg,0.075mg,0.125mg version comes by the name TRIVORA-21, 0.02mg;0.1mg version comes by the name LEVONORGESTREL AND ETHINYL ESTRADIOL, 0.03mg,0.01mg;0.15mg,n/a version comes by the name LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, 0.02mg,0.1mg;0.01mg,n/a version comes by the name LEVONORGESTREL AND ETHINYL ESTRADIOL 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
0.03MG; 0.15MG

(reference standard)

tablet Prescription ORAL-28 AB Dec 13, 1993
0.03MG,0.04MG,0.03MG; 0.05MG,0.075MG,0.125MG tablet Discontinued ORAL-21 N/A Dec 18, 1997
0.02MG; 0.1MG

(reference standard)

tablet Prescription ORAL-28 AB2 May 31, 2006
0.03MG,0.01MG; 0.15MG,N/A tablet Prescription ORAL AB May 31, 2011
0.02MG,0.1MG; 0.01MG,N/A tablet Discontinued ORAL N/A Oct 25, 2011