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Last Updated: May 20, 2024

Estradiol - Generic Drug Details

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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, 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-five patent family members in twenty-six countries.

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

Summary for estradiol

International Patents:	185
US Patents:	55
Tradenames:	43
Applicants:	57
NDAs:	84
Drug Master File Entries:	75
Finished Product Suppliers / Packagers:	46
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

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

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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
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-001	May 29, 2018		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lupin Ltd	AMABELZ	estradiol; norethindrone acetate	TABLET;ORAL	203339-002	Jun 20, 2016	BX	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan Technologies	ESTRADIOL	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	206685-004	Aug 15, 2018	AB3	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novast Labs	ESTRADIOL AND NORETHINDRONE ACETATE	estradiol; norethindrone acetate	TABLET;ORAL	210612-002	Apr 3, 2019	AB	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
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-004	Oct 29, 2012	⤷ Try a Trial	⤷ Try a Trial
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-003	Oct 28, 1994	⤷ Try a Trial	⤷ Try a Trial
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-002	Dec 22, 1994	⤷ Try a Trial	⤷ Try a Trial
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-003	Oct 28, 1994	⤷ Try a Trial	⤷ Try a Trial
Sandoz	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-008	Jan 8, 1999	⤷ 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
Argentina	098160		⤷ Try a Trial
Hong Kong	1155942	經皮雌二醇裝置和遞送 (TRANSDERMAL ESTRADIOL DEVICE AND DELIVERY)	⤷ Try a Trial
Japan	2015520236	経皮的ホルモン補充療法	⤷ Try a Trial
China	110290793		⤷ Try a Trial
European Patent Office	2861233		⤷ 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	15C0050	France	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
1214076	SZ 49/2008	Austria	⤷ Try a Trial	PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
0136011	99C0003	Belgium	⤷ Try a Trial	PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
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	CA 2006 00038	Denmark	⤷ Try a Trial	PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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