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Generated: May 29, 2017

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Estradiol - Generic Drug Details

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

is the generic ingredient in thirty-eight branded drugs marketed by Bristol Myers Squibb, Novo Nordisk Inc, Duramed Pharms Barr, Mylan Speciality Lp, Elan Pharma Intl Ltd, Mayne Pharma, Parke Davis, Novartis, Mylan, Vertical Pharms Llc, Lannett Holdings Inc, Women First Hlthcare, Ortho Mcneil Pharm, Noven, Allergan Sales Llc, Amneal Pharms, Ascend Theraps Us, Pharmacia And Upjohn, Bayer Hlthcare, Mylan Technologies, Epic Pharma Inc, Barr Labs Inc, Usl Pharma, Apil, Watson Labs, Exeltis Usa Inc, Par Sterile Products, Luitpold, Sandoz Inc, Watson Labs Inc, Savage Labs, Amneal Pharms Llc, Breckenridge Pharm, Lupin Ltd, Teva Pharms Usa, Mylan Labs Ltd, Noven Pharms Inc, Barr, and Teva Womens, and is included in fifty-eight NDAs. There are eighteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Estradiol has one hundred and eighty patent family members in thirty-four countries.

There are seventy-five drug master file entries for estradiol. Forty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: estradiol

Drug Master File Entries: see list75
Suppliers / Packagers: see list49
Bulk Api Vendors: see list63
Clinical Trials: see list267
Patent Applications: see list9,857
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:estradiol at DailyMed

Pharmacology for Ingredient: estradiol

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

Tentative approvals for ESTRADIOL

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe1MG;2MG;2MGTABLET;ORAL
► Subscribe► Subscribe3MG;2MG;3MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sandoz Inc
estradiol valerate
INJECTABLE;INJECTION040628-001Oct 4, 2007DISCNNoNo► Subscribe► Subscribe
Elan Pharma Intl Ltd
SPRAY;TRANSDERMAL022014-001Jul 27, 2007RXYesYes6,818,226► SubscribeY ► Subscribe
Bristol Myers Squibb
TABLET;ORAL081295-001Jun 30, 1993DISCNNoNo► Subscribe► Subscribe
Lannett Holdings Inc
TABLET;ORAL040138-003Jan 30, 1998DISCNNoNo► Subscribe► Subscribe
Novo Nordisk Inc
TABLET;ORAL040312-002Nov 19, 1999DISCNNoNo► Subscribe► Subscribe
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