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Serving 500+ biopharmaceutical companies globally:

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Generated: June 25, 2017

DrugPatentWatch Database Preview

Ethinyl estradiol; norethindrone acetate - Generic Drug Details

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What are the generic drug sources for ethinyl estradiol; norethindrone acetate and what is the scope of ethinyl estradiol; norethindrone acetate freedom to operate?

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

Ethinyl estradiol; norethindrone acetate has thirty-eight patent family members in twenty-four countries.

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

Summary for Generic Name: ethinyl estradiol; norethindrone acetate

Tradenames:45
Patents:4
Applicants:15
NDAs:51
Drug Master File Entries: see list26
Suppliers / Packagers: see list20
Clinical Trials: see list1,491
Drug Prices:see low prices
DailyMed Link:ethinyl estradiol; norethindrone acetate at DailyMed

Pharmacology for Ingredient: ethinyl estradiol; norethindrone acetate

Tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe0.02MG;1MGTABLET, CHEWABLE;ORAL
► Subscribe► Subscribe0.01MG,0.01MG;1MG,N/ATABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil
LOESTRIN 21 1/20
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21017876-001Approved Prior to Jan 1, 1982ABRXNoNo► Subscribe► Subscribe
Barr Labs Inc
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL090938-001Dec 1, 2014ABRXNoNo► Subscribe► Subscribe
Mylan Labs Ltd
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21202770-001Feb 19, 2015ABRXNoNo► Subscribe► Subscribe
Mylan Labs Ltd
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL202742-001Oct 30, 2014ABRXNoNo► Subscribe► Subscribe
Mylan Labs Ltd
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL205049-001May 31, 2016ABRXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ethinyl estradiol; norethindrone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
ESTROSTEP 21
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21020130-001Oct 9, 19965,010,070► Subscribe
Apil
ESTROSTEP FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28020130-002Oct 9, 19965,010,070► Subscribe
Apil
LO MINASTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET, CHEWABLE, TABLET;ORAL204654-001Jul 24, 20135,552,394► Subscribe
Apil
LO LOESTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL022501-001Oct 21, 20105,552,394► Subscribe
Apil
ESTROSTEP FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28020130-002Oct 9, 19964,962,098► Subscribe
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International Patent Family for Ingredient: ethinyl estradiol; norethindrone acetate

Country Document Number Estimated Expiration
Canada2605299► Subscribe
Israel186656► Subscribe
Germany60024429► Subscribe
New Zealand514649► Subscribe
World Intellectual Property Organization (WIPO)0059482► Subscribe
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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
/2015Austria► SubscribePRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
2015000093Germany► SubscribePRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Julphar
Federal Trade Commission
US Department of Justice
Medtronic
Baxter
Mallinckrodt
Healthtrust
Express Scripts
Covington

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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