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Generated: December 11, 2017

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Norethindrone acetate - Generic Drug Details

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What are the generic drug sources for norethindrone acetate and what is the scope of norethindrone acetate patent protection?

Norethindrone acetate
is the generic ingredient in three branded drugs marketed by Duramed Res, Amneal Pharms, Aurobindo Pharma Ltd, Barr, Glenmark Generics, Mylan Labs Ltd, and Parke Davis, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for norethindrone acetate. Nine suppliers are listed for this compound. There are three tentative approvals for this compound.

Pharmacology for norethindrone acetate

Ingredient-typeProgesterone Congeners
Drug ClassProgestin

Tentative approvals for NORETHINDRONE ACETATE

Applicant Application No. Strength Dosage Form
u► Subscribe1MG;0.01MG;75MGTABLET;ORAL
u► Subscribe1MG;0.02MGTABLET;ORAL
u► Subscribe75MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Duramed ResAYGESTINnorethindrone acetateTABLET;ORAL018405-001Apr 21, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Parke DavisNORLUTATEnorethindrone acetateTABLET;ORAL012184-002Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Glenmark GenericsNORETHINDRONE ACETATEnorethindrone acetateTABLET;ORAL091090-001Jul 21, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdNORETHINDRONE ACETATEnorethindrone acetateTABLET;ORAL204236-001Jan 8, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Labs LtdNORETHINDRONE ACETATEnorethindrone acetateTABLET;ORAL205278-001Nov 10, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Amneal PharmsNORETHINDRONE ACETATEnorethindrone acetateTABLET;ORAL200275-001Jul 30, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
BarrNORETHINDRONE ACETATEnorethindrone acetateTABLET;ORAL075951-001May 25, 2001ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Fuji
Moodys
Cantor Fitzgerald
QuintilesIMS
Johnson and Johnson
Harvard Business School
Accenture
Julphar
Express Scripts
Deloitte

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