➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKinsey
McKesson
Johnson and Johnson
AstraZeneca
Harvard Business School
Merck

Last Updated: April 16, 2021

DrugPatentWatch Database Preview

Estradiol - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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

Estradiol is the generic ingredient in forty branded drugs marketed by Allergan, Alvogen Pine Brook, Mylan, Perrigo Uk Finco, Teva Pharms Usa, Bayer Hlthcare, Amneal, Mylan Technologies, Parke Davis, Noven, Mylan Speciality Lp, Ascend Theraps Us, Vertical Pharms Llc, Pharmacia And Upjohn, Therapeuticsmd Inc, Perrigo Pharma Intl, Women First Hlthcare, Novartis, Ortho Mcneil Pharm, Bristol Myers Squibb, Barr Labs Inc, Epic Pharma Inc, Lannett Holdings Inc, Mayne Pharma, Usl Pharma, Duramed Pharms Barr, Novo Nordisk Inc, Amneal Pharms, Glenmark Pharms Ltd, Millicent, Apil, Dr Reddys, 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, and Teva Womens, and is included in seventy-two NDAs. There are thirty-nine 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 thirty-three patent family members in twenty-six 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

See drug sales revenues for estradiol

Recent Clinical Trials for estradiol

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

SponsorPhase
Merck, S.L., SpainPhase 4
Fundación Santiago Dexeus FontPhase 4
IRCCS San RaffaelePhase 4

See all estradiol clinical trials

Generic filers with tentative approvals for ESTRADIOL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial3MG;2MG;3MGTABLET;ORAL
  Start Trial  Start 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 NDA Submissiondate
IMVEXXY INSERT;VAGINAL estradiol 208564 2019-12-30
MINIVELLE FILM, EXTENDED RELEASE;TRANSDERMAL estradiol 203752 2015-05-08
MINIVELLE FILM, EXTENDED RELEASE;TRANSDERMAL estradiol 203752 2014-08-18
VAGIFEM TABLET;VAGINAL estradiol 020908 2013-01-02
VIVELLE-DOT SYSTEM;TRANSDERMAL estradiol 020538 2010-04-27
CLIMARA FILM, EXTENDED RELEASE;TRANSDERMAL estradiol 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
Amneal ESTRADIOL estradiol SYSTEM;TRANSDERMAL 211293-002 Feb 4, 2019 AB1 RX No No   Start Trial   Start Trial   Start Trial
Bayer Hlthcare CLIMARA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020375-001 Dec 22, 1994 AB2 RX Yes No   Start Trial   Start Trial   Start Trial
Bayer Hlthcare CLIMARA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020375-002 Dec 22, 1994 AB2 RX Yes Yes   Start Trial   Start Trial   Start Trial
Mylan Technologies ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 206685-002 Aug 15, 2018 AB3 RX No No   Start Trial   Start Trial   Start Trial
Barr ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 079193-001 May 11, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE estradiol cypionate; testosterone cypionate INJECTABLE;INJECTION 085603-001 Mar 13, 1986 DISCN No No   Start Trial   Start Trial   Start 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
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-002 Oct 29, 2012   Start Trial   Start Trial
Allergan ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-004 Apr 5, 2002   Start Trial   Start Trial
Novartis VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-005 Aug 16, 2000   Start Trial   Start Trial
Allergan ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-002 Dec 20, 1996   Start Trial   Start Trial
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-004 Oct 29, 2012   Start Trial   Start Trial
Novartis VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-005 Aug 16, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for estradiol

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1453521 122015000093 Germany   Start Trial 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   Start Trial 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
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0771217 07C0001 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0398460 SPC/GB04/032 United Kingdom   Start Trial PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
1453521 C201630040 Spain   Start Trial PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
Harvard Business School
McKesson
AstraZeneca
Dow

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.