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-five branded drugs marketed by Agile, Glenmark Pharms Ltd, Avion Pharms, Lupin Ltd, Novast Labs, Aurobindo Pharma Ltd, Xiromed, Amneal Pharms, 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-six 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: | 55 |
Applicants: | 25 |
NDAs: | 76 |
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 |
Wits Reproductive Health and HIV Institute | Phase 1 |
Merck Sharp & Dohme LLC | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for ethinyl estradiol; levonorgestrel
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Teva Branded Pharm | SEASONALE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021544-001 | Sep 5, 2003 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Dr Reddys Labs Sa | TRIVORA-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 074538-001 | Dec 18, 1997 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novast Labs | SETLAKIN | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 090716-001 | Sep 15, 2014 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Glenmark Pharms Ltd | MARLISSA | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 091452-001 | Feb 29, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Wyeth Pharms Inc | LYBREL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021864-001 | May 22, 2007 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 |
---|---|---|---|---|---|---|---|
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva Branded Pharm | NORDETTE-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 018668-001 | May 10, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Teva Branded Pharm | NORDETTE-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 018782-001 | Jul 21, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | ⤷ Try a Trial | ⤷ Try a Trial |
Avion Pharms | BALCOLTRA | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 208612-001 | Jan 9, 2018 | ⤷ 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 |
---|---|---|---|
Australia | 2005294269 | Methods of hormonal treatment utilizing ascending-dose extended cycle regimens | ⤷ Try a Trial |
Mexico | 2009004616 | METODOS DE TRATAMIENTO HORMONAL QUE UTILIZAN REGIMENES DE CICLO EXTENDIDO DE DOSIS ASCENDENTE. (METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS.) | ⤷ Try a Trial |
Japan | 2010180236 | ORAL CONTRACEPTIVE TO PREVENT PREGNANCY AND DIMINISH PREMENSTRUAL SYMPTOMATOLOGY | ⤷ Try a Trial |
Germany | 112005000909 | ⤷ Try a Trial | |
Mexico | PA04005445 | ANTICONCEPTIVOS ORALES PARA PREVENIR EL EMBARAZO Y DISMINUIR LA SINTOMATOLOGIA PREMENSTRUAL. (ORAL CONTRACEPTIVES TO PREVENT PREGNANCY AND DIMINISH PREMENSTRUAL SYMPTOMATOLOGY.) | ⤷ 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 | CA 2016 00016 | Denmark | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
1214076 | SZ 49/2008 | Austria | ⤷ Try a Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON |
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 |
1453521 | 15C0050 | France | ⤷ Try a 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 |
1453521 | C201630040 | Spain | ⤷ Try a Trial | PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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