Estradiol - Generic Drug Details

✉ Email this page to a colleague

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

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, Solaris Pharma Corp, 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, Endo Operations, Am Regent, Fosun Pharma, Hikma, Xiromed, Savage Labs, Noven Pharms Inc, Lupin Ltd, Barr, Breckenridge Pharm, Naari Pte Ltd, Novast Labs, Aurobindo Pharma Ltd, Myovant Sciences, and Teva Womens, and is included in eighty-five NDAs. There are fifty-six 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-five patent family members in twenty-six countries.

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

Summary for estradiol

International Patents:	185
US Patents:	56
Tradenames:	43
Applicants:	57
NDAs:	85
Drug Master File Entries:	75
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	993
Patent Applications:	7,060
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for estradiol
Drug Sales Revenues:	Drug sales revenues for estradiol
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for estradiol
What excipients (inactive ingredients) are in estradiol?	estradiol excipients list
DailyMed Link:	estradiol at DailyMed

See drug prices for estradiol

See drug sales revenues for estradiol

Recent Clinical Trials for estradiol

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

Sponsor	Phase
Alexion Pharmaceuticals, Inc.	Phase 1
FHI 360	N/A
Gary Schwartz	Phase 1

See all estradiol clinical trials

Generic filers with tentative approvals for ESTRADIOL

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	3MG;2MG;3MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	1MG;2MG;2MG	TABLET;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

Estrogens

Anatomical Therapeutic Chemical (ATC) Classes for estradiol

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novo Nordisk Inc	INNOFEM	estradiol	TABLET;ORAL	040312-001	Nov 19, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vertical Pharms	DIVIGEL	estradiol	GEL;TRANSDERMAL	022038-001	Jun 4, 2007	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Breckenridge Pharm	ESTRADIOL AND NORETHINDRONE ACETATE	estradiol; norethindrone acetate	TABLET;ORAL	078324-001	Apr 17, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis	ESTRADERM	estradiol	SYSTEM;TRANSDERMAL	019081-003	Sep 10, 1986		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-001	Oct 28, 1994	⤷ Sign Up	⤷ Sign Up
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-002	Oct 29, 2012	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	ELESTRIN	estradiol	GEL, METERED;TRANSDERMAL	021813-001	Dec 15, 2006	⤷ Sign Up	⤷ Sign Up
Women First Hlthcare	ESCLIM	estradiol	SYSTEM;TRANSDERMAL	020847-001	Aug 4, 1998	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for estradiol

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Japan	2015017118	エストロゲンの経皮デバイスおよび経皮送達 (TRANSDERMAL ESTROGEN DEVICE AND DELIVERY)	⤷ Sign Up
Chile	2009001556	Sistema de administración transdermica de fármacos que comprende una capa que contiene fármaco que comprende una matriz polimérica que contiene estradiol como unico fármaco; método de elaboración; útil para administrar estradiol.	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2013192251		⤷ Sign Up
Canada	2876964	FORMULATIONS DE PROGESTERONE (PROGESTERONE FORMULATIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for estradiol

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	C01214076/01	Switzerland	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1380301	CA 2009 00017	Denmark	⤷ Sign Up	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
2782584	301153	Netherlands	⤷ Sign Up	PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
0770388	2009/012	Ireland	⤷ Sign Up	PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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

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.