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
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 |
|---|---|---|---|---|
| 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 Loestrin Fe | US7704984 | Extended estrogen dosing contraceptive regimen | Feb 02, 2029 | Apil |
| Lo Minastrin Fe | US5552394 | Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy |
Jul 22, 2014
(Expired) | Apil |
| Lo Minastrin Fe | US6667050 | Chewable oral contraceptive |
Apr 06, 2019
(Expired) | Apil |
| Lo Minastrin Fe | US7704984 | Extended estrogen dosing contraceptive regimen | Feb 02, 2029 | Apil |
| Minastrin 24 Fe | US5552394 | Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy |
Jul 22, 2014
(Expired) | Apil |
| Minastrin 24 Fe | US6667050 | Chewable oral contraceptive |
Apr 06, 2019
(Expired) | Apil |
| Taytulla | US5552394 | Low dose oral contraceptives with less breakthrough bleeding and sustained efficacy |
Jul 22, 2014
(Expired) | Apil |
| Taytulla | US6652880 | Oral pharmaceutical compositions containing long-chain triglycerides and liphophilic surfactants |
Mar 29, 2020
(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.
Latest 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.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| File Marked Found | 05 Apr, 2017 | US6652880 |
| Recordation of Patent Grant Mailed | 25 Nov, 2003 | US6652880 |
| Patent Issue Date Used in PTA Calculation | 25 Nov, 2003 | US6652880 |
| Issue Notification Mailed | 06 Nov, 2003 | US6652880 |
| Receipt into Pubs | 16 Oct, 2003 | US6652880 |
| Application Is Considered Ready for Issue | 13 Oct, 2003 | US6652880 |
| Receipt into Pubs | 01 Oct, 2003 | US6652880 |
| Issue Fee Payment Received | 25 Aug, 2003 | US6652880 |
| Issue Fee Payment Verified | 25 Aug, 2003 | US6652880 |
| Receipt into Pubs | 18 Aug, 2003 | US6652880 |
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Ethinyl Estradiol; Norethindrone Acetate Generics
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.
1. 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 |
2. 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 |
3. 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 |
4. 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 | BX | Nov 18, 2015 |
| 0.0025MG; 0.5MG | tablet | Prescription | ORAL | AB | Dec 10, 2015 |
| 0.005MG; 1MG | tablet | Prescription | ORAL | AB | Dec 10, 2015 |
5. BARR
Barr Laboratories Inc 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 JUNEL FE 1/20, 0.03mg;1.5mg version comes by the name JUNEL FE 1.5/30, 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 |
|---|---|---|---|---|---|
| 0.02MG; 1MG | tablet | Prescription | ORAL-28 | AB | Sep 18, 2003 |
| 0.03MG; 1.5MG
(reference standard) | 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 |
6. BARR LABS INC
Barr Laboratories Inc has filed for 2 different strengths of generic version for Ethinyl Estradiol; Norethindrone Acetate. Out of these 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 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 |
| 0.02MG; 1MG | tablet | Prescription | ORAL | AB | Dec 1, 2014 |
7. 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 |
8. SLAYBACK PHARMA LLC
Slayback Pharma Llc 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 Slayback Pharma Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.02MG; 1MG | capsule | Prescription | ORAL | AB | Dec 18, 2020 |
9. 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 |
10. 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 |
11. 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 |
12. 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 |
13. 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 |
14. 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 |
15. 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 |