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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-four drug master file entries for this compound. Forty-two 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
Drug Prices: :see details

Pharmacology for Tradename: MINIVELLE

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

Clinical Trials for: MINIVELLE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-005Sep 23, 2014RXNo8,231,906Jul 4, 2030YY
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-002Oct 29, 2012RXNo8,231,906Jul 4, 2030YY
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-001Oct 29, 2012RXNo6,841,716Apr 27, 2020Y
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Expired Patents for Tradename: MINIVELLE

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-001Oct 29, 20125,656,286<disabled>
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-003Oct 29, 20125,656,286<disabled>
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-002Oct 29, 20126,024,976<disabled>
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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
Taiwan201004630<disabled in preview>
World Intellectual Property Organization (WIPO)0069422<disabled in preview>
Uruguay31975<disabled in preview>
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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
2009Austria<disabled>PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
2009004,C0770388Lithuania<disabled>PRODUCT 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
C/GB04/032United Kingdom<disabled>PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
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