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Ethinyl estradiol; levonorgestrel - Generic Drug Details
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What are the generic sources for ethinyl estradiol; levonorgestrel and what is the scope of freedom to operate?
Ethinyl estradiol; levonorgestrel
is the generic ingredient in fifty-three branded drugs marketed by Agile, Glenmark Generics, Avion Pharms, Lupin Ltd, Novast Labs, Aurobindo Pharma Ltd, Xiromed, Amneal Pharms, Glenmark Pharms Ltd, Mylan Labs Ltd, Watson Labs, Mayne Pharma, Teva Branded Pharm, Wyeth Pharms Inc, Sun Pharm, Exeltis Usa Inc, Cadence Health, Duramed Pharms Barr, Barr, Bayer Hlthcare, Wyeth Pharms, Novast Labs Ltd, Naari Pte Ltd, and Vintage Pharms Llc, and is included in seventy-three NDAs. There are sixteen 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 sixty-one patent family members in thirty countries.
There are twenty-six drug master file entries for ethinyl estradiol; levonorgestrel. Twenty-one suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for ethinyl estradiol; levonorgestrel
| International Patents: | 161 |
| US Patents: | 16 |
| Tradenames: | 53 |
| Applicants: | 24 |
| NDAs: | 73 |
| Drug Master File Entries: | 26 |
| Suppliers / Packagers: | 21 |
| Clinical Trials: | 57 |
| 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 |
|---|---|
| Society of Family Planning | Phase 4 |
| Oregon Health and Science University | Phase 4 |
| Laboratorios Andromaco S.A. | Phase 1 |
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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Labs Ltd | LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 091663-001 | Dec 21, 2012 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Teva Branded Pharm | SEASONALE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021544-001 | Sep 5, 2003 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Exeltis Usa Inc | TYBLUME | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 209405-001 | Mar 30, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ethinyl estradiol; levonorgestrel
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Wyeth Pharms Inc | TRIPHASIL-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 019190-001 | Nov 1, 1984 | Start Trial | Start Trial |
| Teva Branded Pharm | NORDETTE-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 018668-001 | May 10, 1982 | 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 |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2004098517 | Start Trial |
| China | 100581550 | Start Trial |
| European Patent Office | 2167002 | 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 |
|---|---|---|---|---|
| 1453521 | 15C0050 | France | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129 |
| 1214076 | SZ 49/2008 | Austria | Start Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON |
| 1453521 | C20160011 00192 | Estonia | Start Trial | PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015 |
| >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 verification 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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