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Ethinyl estradiol; norethindrone acetate - Generic Drug Details

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Ethinyl estradiol; norethindrone acetate is the generic ingredient in forty-four branded drugs marketed by Apil, Barr, Lupin Ltd, Barr Labs Inc, Parke Davis, Mayne Pharma, Novast Labs Ltd, Glenmark Generics, Jai Pharma Ltd, Amneal Pharms, Glenmark Pharms Ltd, Vintage Pharms Llc, Lupin Atlantis, and Vintage Pharms, and is included in forty-eight NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-eight patent family members in twenty-four countries.

There are twenty-six drug master file entries for ethinyl estradiol; norethindrone acetate. Seventeen suppliers are listed for this compound.

Summary for Generic Name: ethinyl estradiol; norethindrone acetate

Tradenames:44
Patents:3
Applicants:14
NDAs:48
Drug Master File Entries: see list26
Suppliers / Packaging: see list17
Drug Prices:see low prices

Pharmacology for Ingredient: ethinyl estradiol; norethindrone acetate

Clinical Trials for: ethinyl estradiol; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr
TRI-LEGEST 21
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21076405-001Oct 26, 2007RXNo
Apil
FEMHRT
ethinyl estradiol; norethindrone acetate
TABLET;ORAL021065-001Jan 14, 2005RXNo
Parke Davis
NORLESTRIN 28 1/50
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28016723-001Approved Prior to Jan 1, 1982DISCNNo
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Expired Orange Book Patents for Generic Ingredient: ethinyl estradiol; norethindrone acetate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
FEMHRT
ethinyl estradiol; norethindrone acetate
TABLET;ORAL021065-001Jan 14, 20055,208,225<disabled>
Apil
TAYTULLA
ethinyl estradiol; norethindrone acetate
CAPSULE;ORAL204426-001Apr 19, 20135,552,394<disabled>
Apil
LO LOESTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL022501-001Oct 21, 20105,552,394<disabled>
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International Patent Family for Ingredient: ethinyl estradiol; norethindrone acetate

Country Document Number Estimated Expiration
Russian Federation2207859<disabled in preview>
Australia763971<disabled in preview>
Norway20014719<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: ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00221Netherlands<disabled>PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2016 00016Denmark<disabled>PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
C0001France<disabled>PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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