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Last Updated: March 28, 2024

ESTRADIOL - Generic Drug Details


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What are the generic drug sources for estradiol and what is the scope of freedom to operate?

Estradiol is the generic ingredient in forty-three branded drugs marketed by Allergan, Alvogen, Mylan, Padagis Israel, Prasco, Teva Pharms Usa, Abbvie, Bayer Hlthcare, Amneal, Mylan Technologies, Zydus Pharms, Parke Davis, Noven, Mylan Speciality Lp, Ascend Theraps Us, Vertical Pharms, Chemo Research Sl, Novitium Pharma, Pfizer, Mayne Pharma, Padagis Us, Women First Hlthcare, Novartis, Ortho Mcneil Pharm, Sandoz, Bristol Myers Squibb, Barr Labs Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Lannett Co Inc, 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, Xiromed, Savage Labs, Noven Pharms Inc, Lupin Ltd, Barr, Breckenridge Pharm, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Aurobindo Pharma Ltd, Myovant Sciences, and Teva Womens, and is included in eighty-four NDAs. There are fifty-five 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-two patent family members in twenty-six countries.

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

Drug Prices for ESTRADIOL

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Drug Sales Revenue Trends for ESTRADIOL

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Recent Clinical Trials for ESTRADIOL

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

SponsorPhase
Dartmouth-Hitchcock Medical CenterPhase 1
Gary SchwartzPhase 1
Beni-Suef UniversityPhase 2/Phase 3

See all ESTRADIOL clinical trials

Generic filers with tentative approvals for ESTRADIOL
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial3MG;2MG;3MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial1MG;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 ClassEstrogen
Mechanism of ActionEstrogen 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
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Fosun Pharma ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 040628-001 Oct 4, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Technologies ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 206685-004 Aug 15, 2018 AB3 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novo Nordisk Inc INNOFEM estradiol TABLET;ORAL 040312-003 Nov 19, 1999 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mayne Pharma IMVEXXY estradiol INSERT;VAGINAL 208564-001 May 29, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Am Regent ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 090920-001 Jan 19, 2010 AO RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Xiromed ESTRADIOL VALERATE estradiol valerate INJECTABLE;INJECTION 216656-003 Apr 28, 2023 AO RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-006 Jan 8, 1999 ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-002 Oct 28, 1994 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-003 Dec 20, 1996 ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-007 Jan 8, 1999 ⤷  Try a Trial ⤷  Try a Trial
Bayer Hlthcare CLIMARA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020375-002 Dec 22, 1994 ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-001 Oct 28, 1994 ⤷  Try a Trial ⤷  Try a Trial
Sandoz VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-005 Jan 8, 1999 ⤷  Try a Trial ⤷  Try a Trial
>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 4309646 FORMULATIONS ET THÉRAPIES DE REMPLACEMENT D'HORMONES COMBINÉES NATURELLES (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2018136161 ⤷  Try a Trial
Russian Federation 2713888 ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ И СПОСОБЫ НА ОСНОВЕ ЭСТРАДИОЛА ДЛЯ ИНТРАВАГИНАЛЬНОГО ВВЕДЕНИЯ (PHARMACEUTICAL COMPOSITIONS AND METHODS BASED ON OESTRADIOL FOR INTRAVAGINAL INTRODUCTION) ⤷  Try a Trial
Taiwan 201004630 Transdermal estrogen device and use ⤷  Try a Trial
Russian Federation 2019115913 ПРИРОДНЫЕ КОМБИНИРОВАННЫЕ ГОРМОНОЗАМЕСТИТЕЛЬНЫЕ СОСТАВЫ И СПОСОБЫ ТЕРАПИИ ⤷  Try a Trial
Australia 366507 ⤷  Try a Trial
Australia 2018280270 Vaginal inserted estradiol pharmaceutical compositions and methods ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ESTRADIOL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 15C0050 France ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1453521 39/2015 Austria ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1214076 49/2008 Austria ⤷  Try a Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612
0771217 CA 2006 00038 Denmark ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
1453521 CA 2016 00016 Denmark ⤷  Try a Trial PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
0398460 04C0022 France ⤷  Try a Trial PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
0771217 07C0001 France ⤷  Try a Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.