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LO MINASTRIN FE Drug Profile

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Lo Minastrin Fe is a drug marketed by Apil and is included in one NDA. It is available from one supplier. There are two patents protecting this drug.

This drug has nine patent family members in seven countries.

The generic ingredient in LO MINASTRIN FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for Tradename: LO MINASTRIN FE

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Formulation / Manufacturing:see details

Clinical Trials for: LO MINASTRIN FE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
LO MINASTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE, TABLET;ORAL204654-001Jul 24, 2013RXYes6,667,050<disabled>Y <disabled>
Apil
LO MINASTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE, TABLET;ORAL204654-001Jul 24, 2013RXYes7,704,984<disabled> <disabled>
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Expired Patents for Tradename: LO MINASTRIN FE

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
LO MINASTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE, TABLET;ORAL204654-001Jul 24, 20135,552,394<disabled>
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International Patent Family for Tradename: LO MINASTRIN FE

Country Document Number Estimated Expiration
Mexico2007013137<disabled in preview>
Canada2605299<disabled in preview>
European Patent Office1877062<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: LO MINASTRIN FE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009 00017Denmark<disabled>PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2006 00038Denmark<disabled>PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
00221Netherlands<disabled>PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
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