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MINIVELLE Drug Profile

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Which patents cover Minivelle, and what substitute generic drugs are available?

Minivelle is a drug marketed by Noven and is included in one NDA. 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
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-002Oct 29, 2012RXYesNo6,841,716► SubscribeY ► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-005Sep 23, 2014RXYesNo6,841,716► 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;TRANSDERMAL203752-002Oct 29, 20125,656,286► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-004Oct 29, 20126,024,976► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-002Oct 29, 20126,024,976► Subscribe
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-003Oct 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
South Korea20110039331► Subscribe
Russian Federation2526186► Subscribe
Uruguay31975► Subscribe
World Intellectual Property Organization (WIPO)2010006143► Subscribe
China1350451► 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
/2004Austria► SubscribePRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
C0018France► SubscribePRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
C0002Belgium► SubscribePRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
0136011/03Switzerland► SubscribePRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
2009004,C0770388Lithuania► 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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