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Generated: June 26, 2017

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Estradiol; norgestimate - Generic Drug Details

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What are the generic sources for estradiol; norgestimate and what is the scope of estradiol; norgestimate patent protection?

Estradiol; norgestimate
is the generic ingredient in two branded drugs marketed by Barr and Teva Womens, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Estradiol; norgestimate has eighteen patent family members in sixteen countries.

There are seventy-five drug master file entries for estradiol; norgestimate. One supplier is listed for this compound.

Summary for Generic Name: estradiol; norgestimate

Tradenames:2
Patents:3
Applicants:2
NDAs:2
Drug Master File Entries: see list75
Suppliers / Packagers: see list1
Clinical Trials: see list671
Drug Prices:see low prices
DailyMed Link:estradiol; norgestimate at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Womens
PREFEST
estradiol; norgestimate
TABLET;ORAL021040-001Oct 22, 1999DISCNYesNo6,747,019► Subscribe ► Subscribe
Barr
ESTRADIOL AND NORGESTIMATE
estradiol; norgestimate
TABLET;ORAL076812-001Apr 29, 2005RXNoYes► Subscribe► Subscribe
Teva Womens
PREFEST
estradiol; norgestimate
TABLET;ORAL021040-001Oct 22, 1999DISCNYesNo7,320,970► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: estradiol; norgestimate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Womens
PREFEST
estradiol; norgestimate
TABLET;ORAL021040-001Oct 22, 19995,108,995► Subscribe
Teva Womens
PREFEST
estradiol; norgestimate
TABLET;ORAL021040-001Oct 22, 19995,382,573► Subscribe
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Non-Orange Book Patents for Generic Ingredient: estradiol; norgestimate

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
7,078,394Low dose estrogen interrupted hormone replacement therapy► 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: estradiol; norgestimate

Country Document Number Estimated Expiration
Brazil0010968► Subscribe
Argentina029159► Subscribe
Hungary0200416► Subscribe
Turkey200102860► Subscribe
China1200747► 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: ESTRADIOL; NORGESTIMATE

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
2016 00016Denmark► SubscribePRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
/2015Austria► SubscribePRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
Farmers Insurance
Healthtrust
Federal Trade Commission
Novartis
Baxter
Mallinckrodt
Queensland Health
US Department of Justice
Julphar

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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