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-four 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, Dr Reddys Labs Sa, Aurobindo 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, Hetero Labs, Naari Pte Ltd, and Vintage Pharms Llc, and is included in seventy-five 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 eight patent family members in twenty-eight countries.
Twenty-six suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for ethinyl estradiol; levonorgestrel
International Patents: | 108 |
US Patents: | 8 |
Tradenames: | 54 |
Applicants: | 26 |
NDAs: | 75 |
Finished Product Suppliers / Packagers: | 26 |
Clinical Trials: | 58 |
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 |
---|---|
Parexel | Phase 1 |
University of Washington | Phase 1 |
Wits Reproductive Health and HIV Institute | Phase 1 |
Generic filers with tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 0.03MG,0.01MG; 0.15MG,N/A | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a 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 | Estrogen Progestin Progestin-containing Intrauterine System Progestin-containing Intrauterine Device |
Mechanism of Action | Estrogen Receptor Agonists |
Physiological Effect | Inhibit Ovum Fertilization |
Paragraph IV (Patent) Challenges for ETHINYL ESTRADIOL; LEVONORGESTREL
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
BALCOLTRA | Tablets | ethinyl estradiol; levonorgestrel | 0.1 mg/0.02 mg | 208612 | 1 | 2020-07-14 |
QUARTETTE | Tablets | ethinyl estradiol; levonorgestrel | 0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg and 0.01 mg | 204061 | 1 | 2013-07-10 |
LOSEASONIQUE | Tablets | ethinyl estradiol; levonorgestrel | 0.1 mg/0.02 mg and 0.01 mg | 022262 | 1 | 2009-11-16 |
SEASONIQUE | Tablets | ethinyl estradiol; levonorgestrel | 0.15 mg/0.03 mg/0.01 mg | 021840 | 2008-01-22 | |
LYBREL | Tablets | ethinyl estradiol; levonorgestrel | 0.09 mg/0.02 mg | 021864 | 1 | 2007-10-05 |
SEASONALE | Tablets | ethinyl estradiol; levonorgestrel | 0.15 mg/0.03 mg | 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 |
---|---|---|---|---|---|---|---|
Avion Pharms | BALCOLTRA | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 208612-001 | Jan 9, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva Branded Pharm | SEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021840-001 | May 25, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
Wyeth Pharms Inc | TRIPHASIL-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 019190-001 | Nov 1, 1984 | ⤷ Try a Trial | ⤷ Try a Trial |
Wyeth Pharms | TRIPHASIL-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 019192-001 | Nov 1, 1984 | ⤷ Try a Trial | ⤷ Try a Trial |
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ethinyl estradiol; levonorgestrel
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hungary | S1800033 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2004098517 | ⤷ Try a Trial | |
Hong Kong | 1154485 | ⤷ Try a Trial | |
Canada | 2692884 | DISPOSITIF D'ADMINISTRATION DERMIQUE AVEC UN JOINTIN SITU (Dermal delivery device with in situ seal) | ⤷ Try a Trial |
New Zealand | 585546 | Methods of hormonal treatment utilizing contraceptive regimens with continuous estrogen administration | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ethinyl estradiol; levonorgestrel
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1453521 | C 2015 029 | Romania | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129 |
0771217 | CA 2006 00038 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
1214076 | C01214076/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
0398460 | C300221 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
1453521 | 122015000093 | Germany | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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