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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-three branded drugs marketed by Apil, Barr, Lupin Ltd, Barr Labs Inc, Parke Davis, Watson Labs, Novast Labs Ltd, Glenmark Generics, Jai Pharma Ltd, Amneal Pharms, Glenmark Pharms Ltd, Warner Chilcott, 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. Sixteen suppliers are listed for this compound.

Summary for Generic Name: ethinyl estradiol; norethindrone acetate

Tradenames:43
Patents:3
Applicants:15
NDAs:48
Drug Master File Entries: see list26
Suppliers / Packaging: see list16
Formulation / Manufacturing:see details

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
Lupin Ltd
FYAVOLV
ethinyl estradiol; norethindrone acetate
TABLET;ORAL204213-002Dec 10, 2015RXNo<disabled><disabled>
Vintage Pharms Llc
GILDESS 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21077075-002Jul 24, 2012RXNo<disabled><disabled>
Novast Labs Ltd
LERIBANE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL203435-002Jun 3, 2016RXNo<disabled><disabled>
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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
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
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>
Apil
FEMHRT
ethinyl estradiol; norethindrone acetate
TABLET;ORAL021065-001Jan 14, 20055,208,225<disabled>
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International Patent Family for Ingredient: ethinyl estradiol; norethindrone acetate

Country Document Number Estimated Expiration
Poland350094<disabled in preview>
Canada2605299<disabled in preview>
Israel145567<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
2009 00017Denmark<disabled>PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2016 00016Denmark<disabled>PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
00221Netherlands<disabled>PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
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