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NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE Drug Profile

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Norethindrone Acetate And Ethinyl Estradiol And Ferrous Fumarate is a drug marketed by Apil, Barr Labs Inc, Jai Pharma Ltd, and Amneal Pharms. and is included in four NDAs. It is available from four suppliers. There is one patent protecting this drug.

This drug has twenty-nine patent family members in twenty-three countries.

The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

Summary for Tradename: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Patents:1
Applicants:4
NDAs:4
Suppliers / Packagers: see list4
Formulation / Manufacturing:see details

Clinical Trials for: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone acetate
CAPSULE;ORAL204426-001Apr 19, 2013DISCNNo6,652,880<disabled>Y <disabled>
Amneal Pharms
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL078267-001Sep 1, 2009RXYes<disabled><disabled>
Barr Labs Inc
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL090938-001Dec 1, 2014RXNo<disabled><disabled>
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Expired Patents for Tradename: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone acetate
CAPSULE;ORAL204426-001Apr 19, 20135,552,394<disabled>
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International Patent Family for Tradename: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Country Document Number Estimated Expiration
Czech Republic301724<disabled in preview>
BrazilPI0009373<disabled in preview>
Norway20014719<disabled in preview>
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Supplementary Protection Certificates for Tradename: NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1214076/01Switzerland<disabled>PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
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