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Last Updated: April 24, 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-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
Fosun Pharma	ESTRADIOL VALERATE	estradiol valerate	INJECTABLE;INJECTION	040628-003	Oct 4, 2007		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Myovant Sciences	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-002	Oct 29, 2012	AB3	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Technologies	ESTRADIOL	estradiol	SYSTEM;TRANSDERMAL	201675-005	Dec 19, 2014	AB1	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
Parke Davis	FEMPATCH	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020417-001	Dec 3, 1996	⤷ 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
Canada	2856520	PREPARATIONS ET THERAPIES DE SUBSTITUTION POUR HORMONOTHERAPIE NATURELLE COMBINEE (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)	⤷ Try a Trial
Japan	6397402		⤷ Try a Trial
Portugal	2310001		⤷ Try a Trial
Israel	245139	שיטות והרכבים פרמצבטיים של אסטרדיול להחדרה וגינלית (Vaginal inserted estradiol pharmaceutical compositions and methods)	⤷ Try a Trial
South Korea	20210107915	천연 병용 호르몬 대체 제형 및 요법 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)	⤷ Try a Trial
Mexico	2018006882	COMPOSICIONES FARMACÉUTICAS DE ESTRADIOL INSERTADAS POR VÍA VAGINAL Y MÉTODOS. (VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS.)	⤷ 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
1453521	C201630040	Spain	⤷ Try a 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
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
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
0398460	C300221	Netherlands	⤷ Try a Trial	PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
0770388	PA2009004,C0770388	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
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.