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Generated: December 18, 2017

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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-nine branded drugs marketed by Apil, Lupin Atlantis, Amneal Pharms, Mylan Labs Ltd, Aurobindo Pharma Ltd, Lupin Ltd, Vintage Pharms, Novast Labs Ltd, Barr Labs Inc, Glenmark Generics, Vintage Pharms Llc, Barr, Mayne Pharma, Glenmark Pharms Ltd, and Parke Davis, and is included in fifty-seven NDAs. There are three 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 forty patent family members in twenty-four countries and twelve supplementary protection certificates in eight countries.

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

Summary for ethinyl estradiol; norethindrone acetate

Pharmacology for ethinyl estradiol; norethindrone acetate

Tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Applicant Application No. Strength Dosage Form
u► Subscribe0.02MG;1MGTABLET, CHEWABLE;ORAL
u► 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
Mayne PharmaMICROGESTIN 1/20ethinyl estradiol; norethindrone acetateTABLET;ORAL-21075647-002Jul 30, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Novast Labs LtdLARIN 1.5/30ethinyl estradiol; norethindrone acetateTABLET;ORAL-21202996-001Mar 20, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
ApilLO LOESTRIN FEethinyl estradiol; norethindrone acetateTABLET;ORAL022501-001Oct 21, 2010ABRXYesYes► Subscribe► Subscribe► Subscribe
Barr Labs IncNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLethinyl estradiol; norethindrone acetateTABLET;ORAL076221-001Nov 6, 2009ABRXNoYes► Subscribe► Subscribe► Subscribe
ApilLOESTRIN FE 1/20ethinyl estradiol; norethindrone acetateTABLET;ORAL-28017354-001Approved Prior to Jan 1, 1982ABRXYesNo► Subscribe► Subscribe► Subscribe
Parke DavisNORLESTRIN 21 2.5/50ethinyl estradiol; norethindrone acetateTABLET;ORAL-21016852-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdAUROVELA 1/20ethinyl estradiol; norethindrone acetateTABLET;ORAL-21207506-001Jun 16, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
ApilFEMHRTethinyl estradiol; norethindrone acetateTABLET;ORAL021065-001Jan 14, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdAUROVELA FE 1/20ethinyl estradiol; norethindrone acetateTABLET;ORAL-28207505-001Jun 16, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Vintage Pharms LlcGILDESS FE 1/20ethinyl estradiol; norethindrone acetateTABLET;ORAL-28077077-001May 20, 2005ABRXNoNo► Subscribe► 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
ApilESTROSTEP 21ethinyl estradiol; norethindrone acetateTABLET;ORAL-21020130-001Oct 9, 1996► Subscribe► Subscribe
ApilFEMHRTethinyl estradiol; norethindrone acetateTABLET;ORAL021065-001Jan 14, 2005► Subscribe► Subscribe
ApilESTROSTEP 21ethinyl estradiol; norethindrone acetateTABLET;ORAL-21020130-001Oct 9, 1996► Subscribe► Subscribe
ApilTAYTULLAethinyl estradiol; norethindrone acetateCAPSULE;ORAL204426-001Apr 19, 2013► Subscribe► Subscribe
ApilLO LOESTRIN FEethinyl estradiol; norethindrone acetateTABLET;ORAL022501-001Oct 21, 2010► Subscribe► Subscribe
ApilESTROSTEP FEethinyl estradiol; norethindrone acetateTABLET;ORAL-28020130-002Oct 9, 1996► Subscribe► Subscribe
ApilFEMHRTethinyl estradiol; norethindrone acetateTABLET;ORAL021065-002Oct 15, 1999► Subscribe► Subscribe
ApilMINASTRIN 24 FEethinyl estradiol; norethindrone acetateTABLET, CHEWABLE;ORAL203667-001May 8, 2013► Subscribe► Subscribe
ApilLO MINASTRIN FEethinyl estradiol; norethindrone acetateTABLET, CHEWABLE, TABLET;ORAL204654-001Jul 24, 2013► Subscribe► Subscribe
ApilESTROSTEP FEethinyl estradiol; norethindrone acetateTABLET;ORAL-28020130-002Oct 9, 1996► Subscribe► Subscribe
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International Patent Family for Ingredient: ethinyl estradiol; norethindrone acetate

Country Document Number Estimated Expiration
Hong Kong1205468► Subscribe
Turkey200102861► Subscribe
United Kingdom9907715► Subscribe
European Patent Office1173153► Subscribe
Mexico2007013137► Subscribe
BrazilPI0009373► Subscribe
Japan4636692► Subscribe
World Intellectual Property Organization (WIPO)2006115871► Subscribe
Austria311177► Subscribe
European Patent Office2305266► 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
0814Netherlands► SubscribePRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
2009 00017Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
/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
49/2008Austria► SubscribePRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
156Luxembourg► SubscribePRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
2006 00038Denmark► SubscribePRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
C0001France► SubscribePRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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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Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
Teva
Farmers Insurance
Baxter
Federal Trade Commission
Fuji
Cantor Fitzgerald
US Department of Justice
Colorcon

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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