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Generated: December 18, 2017

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Ethinyl estradiol; norethindrone - Generic Drug Details

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

Ethinyl estradiol; norethindrone
is the generic ingredient in one hundred and seven branded drugs marketed by Apil, Lupin Ltd, Aurobindo Pharma Ltd, Accord Hlthcare, Amneal Pharms, Barr, Mylan Labs Ltd, Allergan Sales Llc, Ortho Mcneil Pharm, LPI, Watson Pharms Teva, Watson Labs, Watson Labs Teva, Ortho Mcneil Janssen, Janssen Pharms, Warner Chilcott, Mayne Pharma, Glenmark Generics, Vintage Pharms, Vintage Pharms Llc, Novast Labs Ltd, Warner Chilcott Llc, Lupin Atlantis, Barr Labs Inc, Glenmark Pharms Ltd, and Parke Davis, and is included in one hundred and thirty-two NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

Summary for ethinyl estradiol; norethindrone

Pharmacology for ethinyl estradiol; norethindrone

Tentative approvals for ETHINYL ESTRADIOL; NORETHINDRONE

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
Vintage Pharms LlcCYCLAFEM 1/35ethinyl estradiol; norethindroneTABLET;ORAL-28076337-001Nov 12, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
ApilLOESTRIN 21 1.5/30ethinyl estradiol; norethindrone acetateTABLET;ORAL-21017875-001Approved Prior to Jan 1, 1982ABRXNoNo► Subscribe► Subscribe► Subscribe
BarrARANELLEethinyl estradiol; norethindroneTABLET;ORAL-28076783-001Sep 29, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Labs LtdNORETHINDRONE ACETATE AND ETHINYL ESTRADIOLethinyl estradiol; norethindrone acetateTABLET;ORAL-21202770-001Feb 19, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson LabsNORETHINDRONE AND ETHINYL ESTRADIOLethinyl estradiol; norethindroneTABLET;ORAL-21078379-001Feb 23, 2010DISCNNoNo► Subscribe► Subscribe► Subscribe
ApilLO LOESTRIN FEethinyl estradiol; norethindrone acetateTABLET;ORAL022501-001Oct 21, 2010ABRXYesYes► Subscribe► Subscribe► Subscribe
Watson Pharms TevaNORETHINDRONE AND ETHINYL ESTRADIOLethinyl estradiol; norethindroneTABLET;ORAL-21070685-001Jan 29, 1987DISCNNoNo► Subscribe► Subscribe► Subscribe
Watson LabsNORETHINDRONE AND ETHINYL ESTRADIOLethinyl estradiol; norethindroneTABLET;ORAL-28076393-001Feb 4, 2010DISCNNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdAUROVELA 1.5/30ethinyl estradiol; norethindrone acetateTABLET;ORAL-21207581-001Jun 26, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Ortho Mcneil JanssenORTHO-NOVUM 10/11-28ethinyl estradiol; norethindroneTABLET;ORAL-28018354-002Jan 11, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: ethinyl estradiol; norethindrone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen PharmsORTHO-NOVUM 7/7/7-28ethinyl estradiol; norethindroneTABLET;ORAL-28018985-002Apr 4, 1984► Subscribe► Subscribe
Janssen PharmsORTHO-NOVUM 7/7/7-21ethinyl estradiol; norethindroneTABLET;ORAL-21018985-001Apr 4, 1984► Subscribe► Subscribe
Janssen PharmsORTHO-NOVUM 7/7/7-28ethinyl estradiol; norethindroneTABLET;ORAL-28018985-002Apr 4, 1984► Subscribe► Subscribe
ApilNORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATEethinyl estradiol; norethindroneTABLET, CHEWABLE;ORAL022573-001Dec 22, 2010► Subscribe► Subscribe
Janssen PharmsORTHO-NOVUM 7/7/7-28ethinyl estradiol; norethindroneTABLET;ORAL-28018985-002Apr 4, 1984► Subscribe► Subscribe
Mayne PharmaTRI-NORINYL 28-DAYethinyl estradiol; norethindroneTABLET;ORAL-28018977-002Apr 13, 1984► Subscribe► Subscribe
Mayne PharmaTRI-NORINYL 21-DAYethinyl estradiol; norethindroneTABLET;ORAL-21018977-001Apr 13, 1984► Subscribe► Subscribe
Janssen PharmsORTHO-NOVUM 7/7/7-21ethinyl estradiol; norethindroneTABLET;ORAL-21018985-001Apr 4, 1984► Subscribe► Subscribe
Janssen PharmsORTHO-NOVUM 7/7/7-21ethinyl estradiol; norethindroneTABLET;ORAL-21018985-001Apr 4, 1984► Subscribe► Subscribe
Janssen PharmsORTHO-NOVUM 7/7/7-21ethinyl estradiol; norethindroneTABLET;ORAL-21018985-001Apr 4, 1984► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Baxter
Moodys
McKesson
Medtronic
Colorcon
Healthtrust
Cerilliant
Cantor Fitzgerald
Harvard Business School
Accenture

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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