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Estradiol - Generic Drug Details

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Estradiol is the generic ingredient in thirty-seven branded drugs marketed by Bristol Myers Squibb, Novo Nordisk Inc, Duramed Pharms Barr, Meda Pharms, Elan Pharma Intl Ltd, Watson Labs, 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, Medicis, Par Sterile Products, Luitpold, Sandoz, Watson Labs Inc, Savage Labs, Amneal Pharms Llc, Breckenridge Pharm, Teva Pharms Usa, Noven Pharms Inc, Barr, and Teva Womens, and is included in fifty-six NDAs. There are eighteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and seventy-eight patent family members in thirty-four countries.

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

Summary for Generic Name: estradiol

Tradenames:37
Patents:18
Applicants:36
NDAs:56
Drug Master File Entries: see list74
Suppliers / Packaging: see list41
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details

Pharmacology for Ingredient: estradiol

Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists

Tentative approvals for ESTRADIOL

Applicant Application No. Form Dosage
<disabled><disabled>TABLET;ORAL1MG;2MG;2MG
<disabled><disabled>TABLET;ORAL3MG;2MG;3MG

Clinical Trials for: estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare
MENOSTAR
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL021674-001Jun 8, 2004RXYes5,891,868<disabled>Y <disabled>
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-003Oct 29, 2012RXNo6,841,716<disabled>Y <disabled>
Novartis
ESTRADERM
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL019081-003Sep 10, 1986RXYes<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: estradiol

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Allergan Sales Llc
ALORA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020655-002Dec 20, 19965,227,169<disabled>
Allergan Sales Llc
ALORA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020655-001Dec 20, 19965,122,383<disabled>
Novartis
VIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020323-003Oct 28, 19945,300,291<disabled>
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Non-Orange Book Patents for Generic Ingredient: estradiol

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,929,801 Transdermal delivery of antiparkinson agents<disabled in preview>
7,387,789Transdermal delivery of non-steroidal anti-inflammatory drugs<disabled in preview>
7,387,788Pharmaceutical compositions of nicotine and methods of use thereof<disabled in preview>
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International Patent Family for Ingredient: estradiol

Country Document Number Estimated Expiration
Germany69739931<disabled in preview>
European Patent Office1670433<disabled in preview>
World Intellectual Property Organization (WIPO)0211768<disabled in preview>
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Supplementary Protection Certificates for Tradename: ESTRADIOL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
972Luxembourg<disabled>91972, EXPIRES: 20220219
00C/027Belgium<disabled>PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
2012 00011Denmark<disabled>
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