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Serving leading biopharmaceutical companies globally:

AstraZeneca
Cerilliant
Citi
McKesson
Queensland Health
Medtronic
Johnson and Johnson
Dow
Deloitte
Daiichi Sankyo

Generated: January 19, 2018

DrugPatentWatch Database Preview

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?

Estradiol
is the generic ingredient in thirty-eight branded drugs marketed by Allergan Sales Llc, Bayer Hlthcare, Women First Hlthcare, Novartis, Mylan Technologies, Ortho Mcneil Pharm, Parke Davis, Noven, Mylan Speciality Lp, Ascend Theraps Us, Vertical Pharms Llc, Pharmacia And Upjohn, Perrigo Pharma Intl, Bristol Myers Squibb, Barr Labs Inc, Epic Pharma Inc, Lannett Holdings Inc, Mayne Pharma, Mylan, Usl Pharma, Duramed Pharms Barr, Novo Nordisk Inc, Amneal Pharms, Teva Pharms Usa, Apil, Watson Labs, Exeltis Usa Inc, Par Sterile Products, Luitpold, Sandoz Inc, Watson Labs Inc, Savage Labs, Noven Pharms Inc, Amneal Pharms Llc, Lupin Ltd, Barr, Breckenridge Pharm, Mylan Labs Ltd, and Teva Womens, and is included in fifty-nine NDAs. There are nineteen 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 ninety-eight patent family members in thirty-four countries.

There are seventy-five drug master file entries for estradiol. Fifty suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for estradiol
Pharmacology for estradiol
Ingredient-typeEstradiol Congeners
Drug ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for estradiol
Tentative approvals for ESTRADIOL
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe1MG;2MG;2MGTABLET;ORAL
➤ Subscribe➤ Subscribe3MG;2MG;3MGTABLET;ORAL

US Patents and Regulatory Information for estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb ESTRACE estradiol TABLET;ORAL 081295-001 Jun 30, 1993 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-005 Jan 8, 1999 AB1 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Technologies ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 201675-002 Dec 19, 2014 AB1 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Bayer Hlthcare MENOSTAR estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 021674-001 Jun 8, 2004 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Mylan Technologies ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 075182-002 Jan 26, 2005 AB2 RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-001 Oct 29, 2012 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Women First Hlthcare ESCLIM estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020847-002 Aug 4, 1998 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pharmacia And Upjohn DEPO-TESTADIOL estradiol cypionate; testosterone cypionate INJECTABLE;INJECTION 017968-001 Approved Prior to Jan 1, 1982 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Breckenridge Pharm ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 078324-002 Jun 9, 2011 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Allergan Sales Llc ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-002 Dec 20, 1996 BX RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis VIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020323-005 Aug 16, 2000 ➤ Subscribe ➤ Subscribe
Novartis VIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020323-004 Oct 28, 1994 ➤ Subscribe ➤ Subscribe
Novartis VIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020323-001 Oct 28, 1994 ➤ Subscribe ➤ Subscribe
Pharmacia And Upjohn ESTRING estradiol INSERT, EXTENDED RELEASE;VAGINAL 020472-001 Apr 26, 1996 ➤ Subscribe ➤ Subscribe
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-007 Jan 8, 1999 ➤ Subscribe ➤ Subscribe
Parke Davis FEMPATCH estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020417-001 Dec 3, 1996 ➤ Subscribe ➤ Subscribe
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-008 Jan 8, 1999 ➤ Subscribe ➤ Subscribe
Novartis VIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020323-001 Oct 28, 1994 ➤ Subscribe ➤ Subscribe
Allergan Sales Llc ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-004 Apr 5, 2002 ➤ Subscribe ➤ Subscribe
Novartis VIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020323-002 Oct 28, 1994 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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
8,652,491 Transdermal compositions for anticholinergic agents ➤ Subscribe
6,998,138 Topical delivery of anti-alopecia agents ➤ Subscribe
7,214,381 Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels ➤ Subscribe
7,438,203 Dermal penetration enhancers and drug delivery systems involving same ➤ Subscribe
7,094,422 Topical delivery of antifungal agents ➤ Subscribe
6,916,486 Transdermal delivery of analgesics ➤ Subscribe
8,071,075 Dermal penetration enhancers and drug delivery systems involving the same ➤ Subscribe
6,916,487 Transdermal delivery of antiemetics ➤ Subscribe
7,335,379 Transdermal pharmaceutical formulation for minimizing skin residues ➤ Subscribe
8,980,290 Transdermal compositions for anticholinergic agents ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for estradiol

Supplementary Protection Certificates for estradiol

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009004 Lithuania ➤ Subscribe PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
/2015 Austria ➤ Subscribe PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
09/012 Ireland ➤ Subscribe PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
00522 Netherlands ➤ Subscribe PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
C0004 Belgium ➤ Subscribe PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
00C/027 Belgium ➤ Subscribe PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
C0022 France ➤ Subscribe PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
2016 00016 Denmark ➤ Subscribe PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
/2004 Austria ➤ Subscribe PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
156 Luxembourg ➤ Subscribe PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Chubb
Covington
McKesson
Colorcon
QuintilesIMS
Chinese Patent Office
Medtronic
Deloitte
Citi

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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