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Ethinyl estradiol; levonorgestrel - Generic Drug Details

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Ethinyl estradiol; levonorgestrel is the generic ingredient in forty-three branded drugs marketed by Watson Labs, Sandoz, Vintage Pharms Llc, Barr, Mayne Pharma, Sandoz Inc, Lupin Ltd, Amneal Pharms, Duramed Pharms Barr, Novast Labs Ltd, Teva Branded Pharm, Jai Pharma Ltd, Glenmark Generics, Bayer Hlthcare, Glenmark Pharms Ltd, Wyeth Pharms Inc, Aurobindo Pharma Ltd, and Wyeth Pharms, and is included in fifty-eight NDAs. There are ten patents protecting this compound and five Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and three patent family members in twenty-six countries.

There are twenty-six drug master file entries for ethinyl estradiol; levonorgestrel. Twenty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: ethinyl estradiol; levonorgestrel

Tradenames:43
Patents:10
Applicants:18
NDAs:58
Drug Master File Entries: see list26
Suppliers / Packagers: see list25
Clinical Trials: see list310
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: ethinyl estradiol; levonorgestrel

Tentative approvals for ETHINYL ESTRADIOL; LEVONORGESTREL

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL0.03MG,0.01MG; 0.15MG,N/A
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Branded Pharm
SEASONIQUE
ethinyl estradiol; levonorgestrel
TABLET;ORAL021840-001May 25, 2006RXYes7,858,605► subscribeY ► subscribe
Teva Branded Pharm
LOSEASONIQUE
ethinyl estradiol; levonorgestrel
TABLET;ORAL022262-001Oct 24, 2008RXNo7,615,545► subscribe ► subscribe
Lupin Ltd
LEVONORGESTREL AND ETHINYL ESTRADIOL
ethinyl estradiol; levonorgestrel
TABLET;ORAL091440-001Oct 23, 2012RXNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: ethinyl estradiol; levonorgestrel

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Wyeth Pharms
TRIPHASIL-21
ethinyl estradiol; levonorgestrel
TABLET;ORAL-21019192-001Nov 1, 19843,850,911► subscribe
Wyeth Pharms Inc
TRIPHASIL-28
ethinyl estradiol; levonorgestrel
TABLET;ORAL-28019190-001Nov 1, 19843,959,322► subscribe
Teva Branded Pharm
NORDETTE-21
ethinyl estradiol; levonorgestrel
TABLET;ORAL-21018668-001May 10, 19823,666,858► subscribe
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Non-Orange Book Patents for Generic Ingredient: ethinyl estradiol; levonorgestrel

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,680,084Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology► subscribe
8,338,396Oral contraceptives to prevent pregnancy and diminish premenstrual symptomatology► subscribe
7,772,219Methods of hormonal treatment utilizing extended cycle contraceptive regimens► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: ethinyl estradiol; levonorgestrel

Country Document Number Estimated Expiration
European Patent Office1935423► subscribe
Australia2002348272► subscribe
Russian Federation2009120528► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ETHINYL ESTRADIOL; LEVONORGESTREL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1214076/01Switzerland► subscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
00221Netherlands► subscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
C0001France► subscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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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 verifification 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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