➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Harvard Business School
Johnson and Johnson
Colorcon
McKinsey

Last Updated: September 18, 2020

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 freedom to operate?

Estradiol is the generic ingredient in forty branded drugs marketed by Allergan, Alvogen Pine Brook, Mylan, Perrigo Uk Finco, Teva Pharms Usa, Bayer Hlthcare, Women First Hlthcare, Novartis, Amneal, Mylan Technologies, Ortho Mcneil Pharm, Parke Davis, Noven, Mylan Speciality Lp, Ascend Theraps Us, Vertical Pharms Llc, Pharmacia And Upjohn, Therapeuticsmd Inc, Perrigo Pharma Intl, 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-one NDAs. There are thirty-six 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 twenty-nine patent family members in twenty-six countries.

There are seventy-five drug master file entries for estradiol. Thirty-nine suppliers are listed for this compound. There are two tentative approvals 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
St. Louis UniversityPhase 2
Assiut UniversityEarly Phase 1
El Shatby University Hospital for Obstetrics and GynecologyPhase 3

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
  Start Trial  Start Trial0.1MG/24HRFILM, EXTENDED RELEASE;TRANSDERMAL

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 FILM, EXTENDED RELEASE;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
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
Mylan Technologies ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 206685-003 Aug 15, 2018 AB3 RX No No   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 207261-001 Feb 10, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Therapeuticsmd Inc BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Bayer Hlthcare CLIMARA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020375-005 May 27, 2003 AB2 RX Yes 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
Novartis VIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020323-003 Oct 28, 1994   Start Trial   Start Trial
Allergan ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-002 Dec 20, 1996   Start Trial   Start Trial
Novartis VIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020323-004 Oct 28, 1994   Start Trial   Start Trial
Bayer Hlthcare CLIMARA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020375-004 Mar 5, 1999   Start Trial   Start Trial
Allergan ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-002 Dec 20, 1996   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
1380301 CA 2009 00017 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
0770388 09C0018 France   Start Trial PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0136011 2000C/027 Belgium   Start Trial PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0771217 07C0001 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0770388 9/2009 Austria   Start Trial PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
>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:

Johnson and Johnson
Mallinckrodt
Moodys
McKinsey
McKesson
Medtronic

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.