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MINIVELLE Drug Profile

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Minivelle is a drug marketed by Noven and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has twenty-six patent family members in eighteen countries.

The generic ingredient in MINIVELLE is estradiol. There are seventy-five drug master file entries for this compound. Forty-eight suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the estradiol profile page.

Summary for Tradename: MINIVELLE

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list64
Patent Applications: see list19,678
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:MINIVELLE at DailyMed

Pharmacology for Tradename: MINIVELLE

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-005Sep 23, 2014RXYesNo8,231,906► subscribeYY ► subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-002Oct 29, 2012RXYesNo8,231,906► subscribeYY ► subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-001Oct 29, 2012RXYesNo6,841,716► subscribeY ► subscribe
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Expired Patents for Tradename: MINIVELLE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-001Oct 29, 20125,656,286► subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-003Oct 29, 20125,656,286► subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-004Oct 29, 20125,656,286► subscribe
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Paragraph IV activity for: MINIVELLE

Drugname Dosage Strength RLD Submissiondate
estradiolTransdermal System0.025 mg/dayMinivelle5/8/2015
estradiolTransdermal System0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, 0.1 mg/dayMinivelle8/18/2014

International Patent Family for Tradename: MINIVELLE

Country Document Number Estimated Expiration
China1177585► subscribe
Mexico2011000332► subscribe
Taiwan532145► 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: MINIVELLE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0004Belgium► subscribePRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
2006 00038Denmark► subscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
2009004Lithuania► subscribePRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
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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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