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Ethinyl estradiol; levonorgestrel - Generic Drug Details
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What are the generic drug sources for ethinyl estradiol; levonorgestrel and what is the scope of patent protection?
Ethinyl estradiol; levonorgestrel
is the generic ingredient in fifty branded drugs marketed by Glenmark Generics, Avion Pharms, Lupin Ltd, Aurobindo Pharma Ltd, Xiromed, Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, Watson Labs, Mayne Pharma, Teva Branded Pharm, Wyeth Pharms Inc, Novast Labs, Sun Pharm, Cadence Health, Duramed Pharms Barr, Barr, Bayer Hlthcare, Wyeth Pharms, Novast Labs Ltd, and Vintage Pharms Llc, and is included in sixty-eight NDAs. There are eight patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Ethinyl estradiol; levonorgestrel has one hundred and three patent family members in twenty-six countries.
There are twenty-six drug master file entries for ethinyl estradiol; levonorgestrel. Twenty suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for ethinyl estradiol; levonorgestrel
| International Patents: | 103 |
| US Patents: | 8 |
| Tradenames: | 50 |
| Applicants: | 21 |
| NDAs: | 68 |
| Drug Master File Entries: | 26 |
| Suppliers / Packagers: | 20 |
| Clinical Trials: | 54 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ethinyl estradiol; levonorgestrel |
| DailyMed Link: | ethinyl estradiol; levonorgestrel at DailyMed |
Recent Clinical Trials for ethinyl estradiol; levonorgestrel
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Laboratorios Andromaco S.A. | Phase 1 |
| Assembly Biosciences | Phase 1 |
| University of Sao Paulo | Phase 4 |
Recent Litigation for ethinyl estradiol; levonorgestrel
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Teva Women's Health, Inc. v. Famy Care Ltd. | 2014-12-05 |
| Teva Women's Health, Inc. v. Famy Care Ltd. | 2014-07-02 |
| TEVA WOMEN'S HEALTH, INC. v. MYLAN PHARMACEUTICALS, INC. | 2010-03-09 |
Generic filers with tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 0.03MG,0.01MG; 0.15MG,N/A | TABLET;ORAL |
| Start Trial | Start Trial | 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for ethinyl estradiol; levonorgestrel
| Drug Class | Progestin Progestin-containing Intrauterine Device Estrogen |
| Mechanism of Action | Estrogen Receptor Agonists |
| Physiological Effect | Inhibit Ovum Fertilization |
Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; LEVONORGESTREL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| QUARTETTE | TABLET;ORAL | ethinyl estradiol; levonorgestrel | 204061 | 2013-07-10 |
| LOSEASONIQUE | TABLET;ORAL | ethinyl estradiol; levonorgestrel | 022262 | 2009-11-16 |
| SEASONIQUE | TABLET;ORAL | ethinyl estradiol; levonorgestrel | 021840 | 2008-01-22 |
| LYBREL | TABLET;ORAL | ethinyl estradiol; levonorgestrel | 021864 | 2007-10-05 |
| SEASONALE | TABLET;ORAL | ethinyl estradiol; levonorgestrel | 021544 | 2004-03-29 |
US Patents and Regulatory Information for ethinyl estradiol; levonorgestrel
Expired US Patents for ethinyl estradiol; levonorgestrel
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Teva Branded Pharm | NORDETTE-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 018782-001 | Jul 21, 1982 | Start Trial | Start Trial |
| Wyeth Pharms Inc | TRIPHASIL-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 019190-001 | Nov 1, 1984 | Start Trial | Start Trial |
| Wyeth Pharms | TRIPHASIL-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 019192-001 | Nov 1, 1984 | Start Trial | Start Trial |
| Wyeth Pharms Inc | LYBREL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021864-001 | May 22, 2007 | Start Trial | Start Trial |
| Wyeth Pharms Inc | TRIPHASIL-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 019190-001 | Nov 1, 1984 | Start Trial | Start Trial |
| Wyeth Pharms | TRIPHASIL-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 019192-001 | Nov 1, 1984 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ethinyl estradiol; levonorgestrel
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Mexico | 2009004616 | Start Trial |
| China | 100581550 | Start Trial |
| Israel | 182287 | Start Trial |
| Hong Kong | 1154485 | Start Trial |
| Slovenia | 1453521 | Start Trial |
| South Africa | 200404249 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ethinyl estradiol; levonorgestrel
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1380301 | CA 2009 00017 | Denmark | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
| 0398460 | C300221 | Netherlands | Start Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
| 0771217 | CA 2006 00038 | Denmark | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
| 0771217 | 07C0001 | France | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 |
| 1214076 | 49/2008 | Austria | Start Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| 1453521 | 2015C/042 | Belgium | Start Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGEMENT DE NOM DU PROPRIETAIRE, NOM/ADRESSE |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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