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PREFEST Drug Profile

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Prefest is a drug marketed by Teva Womens and is included in one NDA. There are two patents protecting this drug.

This drug has eighteen patent family members in sixteen countries.

The generic ingredient in PREFEST is estradiol; norgestimate. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol; norgestimate profile page.

Summary for Tradename: PREFEST

Patents:2
Applicants:1
NDAs:1
Formulation / Manufacturing:see details
Drug Prices: :see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Womens
PREFEST
estradiol; norgestimate
TABLET;ORAL021040-001Oct 22, 1999DISCNNo6,747,019► subscribe ► subscribe
Teva Womens
PREFEST
estradiol; norgestimate
TABLET;ORAL021040-001Oct 22, 1999DISCNNo7,320,970► subscribeY ► subscribe
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Expired Patents for Tradename: PREFEST

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 Tradename: PREFEST

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 Tradename: PREFEST

Country Document Number Estimated Expiration
Czech Republic20013493► subscribe
Hungary0200416► 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: PREFEST

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0002Belgium► subscribePRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
/2004Austria► subscribePRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
1214076/01Switzerland► subscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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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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