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, Mylan Labs Ltd, 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: | 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 |
⤷ Sign Up | ⤷ Sign Up | 0.03MG,0.01MG; 0.15MG,N/A | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Avion Pharms | BALCOLTRA | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 208612-001 | Jan 9, 2018 | AB3 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Xiromed | LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 205131-001 | Dec 14, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novast Labs Ltd | LEVONEST | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 090719-001 | Dec 29, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Barr | LESSINA-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 075803-002 | Mar 20, 2002 | AB2 | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Novast Labs | SETLAKIN | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 090716-001 | Sep 15, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Xiromed | JAIMIESS | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 203770-001 | Dec 27, 2017 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lupin Ltd | FAYOSIM | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 205943-001 | Mar 29, 2016 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 |
---|---|---|---|---|---|---|---|
Teva Branded Pharm | NORDETTE-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 018782-001 | Jul 21, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | PREVEN EMERGENCY CONTRACEPTIVE KIT | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 020946-001 | Sep 1, 1998 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | NORDETTE-21 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-21 | 018668-001 | May 10, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | NORDETTE-28 | ethinyl estradiol; levonorgestrel | TABLET;ORAL-28 | 018782-001 | Jul 21, 1982 | ⤷ Sign Up | ⤷ Sign Up |
Agile | TWIRLA | ethinyl estradiol; levonorgestrel | SYSTEM;TRANSDERMAL | 204017-001 | Feb 14, 2020 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | SEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 021840-001 | May 25, 2006 | ⤷ Sign Up | ⤷ Sign Up |
Teva Branded Pharm | LOSEASONIQUE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 022262-001 | Oct 24, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ethinyl estradiol; levonorgestrel
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Bulgaria | 108736 | ⤷ Sign Up | |
Spain | 2561491 | ⤷ Sign Up | |
Canada | 2524474 | METHODES DE TRAITEMENT HORMONAL FAISANT APPEL A DES SCHEMAS CONTRACEPTIFS A CYCLE PROLONGE (METHODS OF HORMONAL TREATMENT UTILIZING EXTENDED CYCLE CONTRACEPTIVE REGIMENS) | ⤷ Sign Up |
Mexico | PA04005445 | ANTICONCEPTIVOS ORALES PARA PREVENIR EL EMBARAZO Y DISMINUIR LA SINTOMATOLOGIA PREMENSTRUAL. (ORAL CONTRACEPTIVES TO PREVENT PREGNANCY AND DIMINISH PREMENSTRUAL SYMPTOMATOLOGY.) | ⤷ Sign Up |
Canada | 2655959 | CONTRACEPTIFS ORAUX POUR EVITER LES GROSSESSES ET DIMINUER LA SYMPTOMATOLOGIE PREMENSTRUELLE (ORAL CONTRACEPTIVES TO PREVENT PREGNANCY AND DIMINISH PREMENSTRUAL SYMPTOMATOLOGY) | ⤷ Sign Up |
Canada | 2582530 | PROCEDES DE TRAITEMENT HORMONAL UTILISANT DES SCHEMAS POSOLOGIQUES A CYCLE ETENDU A AUGMENTATION DE DOSAGE (METHODS OF HORMONAL TREATMENT UTILIZING ASCENDING-DOSE EXTENDED CYCLE REGIMENS) | ⤷ Sign Up |
Taiwan | 200831107 | Methods of hormonal treatment utilizing ascending-dose extended cycle regimens | ⤷ Sign Up |
>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 | 122015000093 | Germany | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
1453521 | C20160011 00192 | Estonia | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREEL JA ETUENUEUELOESTRADIOOL;REG NO/DATE: EE 894715 11.11.2015 |
1453521 | CA 2016 00016 | Denmark | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211 |
1453521 | 300814 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
1453521 | 132016000025143 | Italy | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414 |
1453521 | C201630040 | Spain | ⤷ Sign Up | 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 |
0771217 | CA 2006 00038 | Denmark | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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