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Last Updated: April 25, 2024

Estradiol - Generic Drug Details

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What are the generic 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, 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-three patent family members in twenty-six countries.

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

Summary for estradiol

International Patents:	183
US Patents:	55
Tradenames:	43
Applicants:	57
NDAs:	84
Drug Master File Entries:	75
Finished Product Suppliers / Packagers:	45
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	987
Patent Applications:	6,728
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
Gary Schwartz	Phase 1
Dartmouth-Hitchcock Medical Center	Phase 1
Beni-Suef University	Phase 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 Trial	3MG;2MG;3MG	TABLET;ORAL
⤷ Try a Trial	⤷ Try a Trial	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

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lupin Ltd	AMABELZ	estradiol; norethindrone acetate	TABLET;ORAL	203339-001	Jun 20, 2016	BX	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-001	Oct 29, 2012	AB3	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Usl Pharma	ESTRADIOL	estradiol	TABLET;ORAL	040297-001	Apr 17, 2002		DISCN	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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-004	Oct 28, 1994	⤷ Try a Trial	⤷ Try a Trial
Pfizer	ESTRING	estradiol	INSERT, EXTENDED RELEASE;VAGINAL	020472-001	Apr 26, 1996	⤷ Try a Trial	⤷ Try a Trial
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-001	Oct 28, 1994	⤷ Try a Trial	⤷ Try a Trial
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-005	Aug 16, 2000	⤷ Try a Trial	⤷ Try a Trial
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-003	Oct 29, 2012	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for estradiol

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013192248		⤷ Try a Trial
Australia	2017208300	Soluble Estradiol Capsule For Vaginal Insertion	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2015148952		⤷ Try a Trial
Australia	2015237243	Progesterone formulations	⤷ Try a Trial
Portugal	2782584		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for estradiol

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	12/2004	Austria	⤷ Try a Trial	PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
0770388	09C0018	France	⤷ Try a Trial	PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0770388	PA2009004	Lithuania	⤷ Try a Trial	PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
2782584	132021000000197	Italy	⤷ Try a Trial	PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
0398460	SPC/GB04/032	United Kingdom	⤷ Try a Trial	PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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