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, 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 Endo Operations, 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-five 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: | 24 |
NDAs: | 76 |
Finished Product Suppliers / Packagers: | 25 |
Clinical Trials: | 60 |
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 |
---|---|
Alexion Pharmaceuticals, Inc. | Phase 1 |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | N/A |
FHI 360 | N/A |
Generic filers with tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL
Applicant | Application No. | Strength | Dosage Form |
⤷ Try for Free | ⤷ Try for Free | 0.03MG,0.01MG; 0.15MG,N/A | TABLET;ORAL |
⤷ Try for Free | ⤷ Try for Free | 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 | 1 | 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 | 1 | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Xiromed | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 200493-001 | Jun 17, 2015 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Barr | LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 075862-002 | Apr 29, 2003 | DISCN | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Glenmark Pharms Ltd | LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 202791-001 | Apr 9, 2015 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Hetero Labs | LEVONORGESTREL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 212298-001 | Feb 13, 2023 | AB1 | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
Avion Pharms | BALCOLTRA | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 208612-001 | Jan 9, 2018 | AB3 | RX | Yes | Yes | 7,838,042 | ⤷ Try for Free | Y | ⤷ Try for Free | ||
Wyeth Pharms Inc | LYBREL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021864-001 | May 22, 2007 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Lupin Ltd | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 091674-001 | Oct 26, 2011 | AB | RX | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | |||
>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 | 3,850,911 | ⤷ Try for Free |
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | 8,221,785 | ⤷ Try for Free |
Wyeth Pharms Inc | LYBREL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021864-001 | May 22, 2007 | 6,500,814 | ⤷ Try for Free |
Avion Pharms | BALCOLTRA | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 208612-001 | Jan 9, 2018 | 6,716,814 | ⤷ Try for Free |
Teva Branded Pharm | LOSEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 022262-001 | Oct 24, 2008 | 7,615,545 | ⤷ Try for Free |
Teva Branded Pharm | NORDETTE-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 018668-001 | May 10, 1982 | 3,850,911 | ⤷ Try for Free |
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | 7,045,145 | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ethinyl estradiol; levonorgestrel
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2428118 | ⤷ Try for Free | |
China | 101757628 | ⤷ Try for Free | |
European Patent Office | 1648382 | PROCEDES DE TRAITEMENT HORMONAL UTILISANT DES POSOLOGIES CONTRACEPTIVES AVEC ADMINISTRATION CONTINUE D'OESTROGENES (METHODS OF HORMONAL TREATMENT UTILIZING CONTRACEPTIVE REGIMENS WITH CONTINUOUS ESTROGEN ADMINISTRATION) | ⤷ Try for Free |
Bulgaria | 108736 | ⤷ Try for Free | |
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 for Free |
Hungary | 230759 | Teherbeesés megakadályozására és menstruációs tünetek enyhítésére vagy kiküszöbölésére alkalmas orális készítmények (Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology) | ⤷ Try for Free |
European Patent Office | 2305230 | Contraceptifs oraux pour empêcher les grossesses (Oral contraceptives to prevent pregnancy) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ethinyl estradiol; levonorgestrel
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1214076 | 49/2008 | Austria | ⤷ Try for Free | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
1453521 | 122015000093 | Germany | ⤷ Try for Free | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
0136011 | 2000C/027 | Belgium | ⤷ Try for Free | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
1453521 | 93156 | Luxembourg | ⤷ Try for Free | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
1453521 | C 2015 029 | Romania | ⤷ Try for Free | 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 |
1453521 | C201630040 | Spain | ⤷ Try for Free | 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 |
1453521 | 300814 | Netherlands | ⤷ Try for Free | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for Ethinyl Estradiol and Levonorgestrel
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