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Estradiol - Generic Drug Details

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Estradiol is the generic ingredient in thirty-eight 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, Exeltis Usa Inc, Par Sterile Products, Luitpold, Sandoz, Watson Labs Inc, Savage Labs, Amneal Pharms Llc, Breckenridge Pharm, Lupin Ltd, Teva Pharms Usa, Noven Pharms Inc, Barr, and Teva Womens, and is included in fifty-seven 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-two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: estradiol

Tradenames:38
Patents:18
Applicants:37
NDAs:57
Drug Master File Entries: see list74
Suppliers / Packaging: see list42
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
Novartis
VIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020323-002Oct 28, 1994RXNo<disabled><disabled>
Mylan Technologies
ESTRADIOL
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL075182-002Jan 26, 2005RXNo<disabled><disabled>
Women First Hlthcare
ESCLIM
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020847-005Aug 4, 1998DISCNNo<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
Bayer Hlthcare
CLIMARA
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020375-006May 27, 20035,223,261<disabled>
Noven
MINIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL203752-002Oct 29, 20125,656,286<disabled>
Novartis
VIVELLE
estradiol
FILM, EXTENDED RELEASE;TRANSDERMAL020323-003Oct 28, 19944,994,278<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
6,964,777 Transdermal delivery of antianxiety agents<disabled in preview>
8,980,309Transdermal testosterone formulation for minimizing skin residues<disabled in preview>
7,214,381Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: estradiol

Country Document Number Estimated Expiration
South Africa200602046<disabled in preview>
Eurasian Patent Organization004573<disabled in preview>
Luxembourg91973<disabled in preview>
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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: ESTRADIOL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0005Belgium<disabled>PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
2006 00038Denmark<disabled>PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
C0022France<disabled>PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
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