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Last Updated: August 9, 2022

Estradiol - Generic Drug Details


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

Estradiol is the generic ingredient in forty-two branded drugs marketed by Allergan, Alvogen, Mylan, Padagis Israel, Prasco Labs Llc, Teva Pharms Usa, Bayer Hlthcare, Amneal, Mylan Technologies, Parke Davis, Noven, Mylan Speciality Lp, Ascend Theraps Us, Vertical Pharms Llc, Pfizer, Therapeuticsmd Inc, Padagis Us, Women First Hlthcare, Novartis, Ortho Mcneil Pharm, Bristol Myers Squibb, Barr Labs Inc, Epic Pharma, Lannett Co Inc, Mayne Pharma, Usl Pharma, Duramed Pharms Barr, Novo Nordisk Inc, Amneal Pharms, Glenmark Pharms Ltd, Millicent, Apil, Dr Reddys, Pharmacia And Upjohn, Watson Labs, Exeltis Usa Inc, Par Sterile Products, Am Regent, Fosun Pharma, Hikma, Savage Labs, Noven Pharms Inc, Lupin Ltd, Barr, Breckenridge Pharm, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Myovant Sciences, and Teva Womens, and is included in seventy-five NDAs. There are fifty-two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Estradiol has two hundred and fifty patent family members in twenty-nine countries.

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

Drug Prices for estradiol

See drug prices for estradiol

Drug Sales Revenue Trends for estradiol

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Recent Clinical Trials for estradiol

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
CRG UZ BrusselPhase 4
Merck Sharp & Dohme LLCPhase 4
University Hospitals Cleveland Medical CenterPhase 4

See all estradiol clinical trials

Generic filers with tentative approvals for ESTRADIOL
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing3MG;2MG;3MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing1MG;2MG;2MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for estradiol
Drug Class Estrogen
Mechanism of Action Estrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for estradiol
Paragraph IV (Patent) Challenges for ESTRADIOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
IMVEXXY Vaginal Inserts estradiol 4 mcg and 10 mcg 208564 1 2019-12-30
MINIVELLE Transdermal System estradiol 0.025 mg/day 203752 1 2015-05-08
MINIVELLE Transdermal System estradiol 0.0375 mg/day 0.05 mg/day 0.075 mg/day 0.1 mg/day 203752 1 2014-08-18
VAGIFEM Vaginal Tablets estradiol 10 mcg 020908 1 2013-01-02
VIVELLE-DOT Transdermal System estradiol 0.025 mg/day 0.0375 mg/day 0.05 mg/days 0.075 mg/day 0.1 mg/day 020538 1 2010-04-27
CLIMARA Transdermal System estradiol 0.05 mg/day and 0.1 mg/day 020375 2005-09-12

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
Duramed Pharms Barr GYNODIOL estradiol TABLET;ORAL 040212-001 Dec 29, 1997 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bayer Hlthcare CLIMARA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020375-005 May 27, 2003 AB2 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Therapeuticsmd Inc IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Labs Ltd ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 207261-002 Feb 10, 2017 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for estradiol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-006 Jan 8, 1999 See Plans and Pricing See Plans and Pricing
Novartis VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-005 Jan 8, 1999 See Plans and Pricing See Plans and Pricing
Allergan ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-003 Dec 20, 1996 See Plans and Pricing See Plans and Pricing
Padagis Us EVAMIST estradiol SPRAY;TRANSDERMAL 022014-001 Jul 27, 2007 See Plans and Pricing See Plans and Pricing
Allergan ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-002 Dec 20, 1996 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for estradiol

Country Patent Number Title Estimated Expiration
European Patent Office 3173078 DISPOSITIF ET ADMINISTRATION TRANSDERMIQUE D' STROGÈNE (TRANSDERMAL ESTROGEN DEVICE AND DELIVERY) See Plans and Pricing
Russian Federation 2011101477 СРЕДСТВО И СПОСОБ ТРАНСДЕРМАЛЬНОЙ ДОСТАВКИ ЭСТРОГЕНА See Plans and Pricing
Australia 2013277235 Transdermal hormone replacement therapies See Plans and Pricing
Japan 2018024688 天然の併用ホルモン補充療法剤及び治療 (NATURAL COMBINATION HORMONE REPLACEMENT THERAPY AGENTS AND THERAPIES) See Plans and Pricing
European Patent Office 3936133 PRÉPARATIONS ET THÉRAPIES DE SUBSTITUTION POUR HORMONOTHÉRAPIE NATURELLE COMBINÉE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for estradiol

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 122015000093 Germany See Plans and Pricing PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
0770388 SPC/GB09/026 United Kingdom See Plans and Pricing PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
2782584 122021000080 Germany See Plans and Pricing PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; NAT. REGISTRATION NO/DATE: 2205034.00.00 20210924; FIRST REGISTRATION: BELGIEN BE582231 20210406
1214076 C01214076/01 Switzerland See Plans and Pricing PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0398460 04C0022 France See Plans and Pricing PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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