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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 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.

Summary for estradiol

International Patents:	229
US Patents:	36
Tradenames:	40
Applicants:	47
NDAs:	71
Drug Master File Entries:	75
Suppliers / Packagers:	39
Bulk Api Vendors:	91
Clinical Trials:	862
Patent Applications:	6,430
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
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
St. Louis University	Phase 2
Assiut University	Early Phase 1
El Shatby University Hospital for Obstetrics and Gynecology	Phase 3

See all estradiol clinical trials

Generic filers with tentative approvals for ESTRADIOL

Applicant	Application No.	Strength	Dosage Form
		3MG;2MG;3MG	TABLET;ORAL
		1MG;2MG;2MG	TABLET;ORAL
		0.1MG/24HR	FILM, 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 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	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
Mylan Technologies	ESTRADIOL	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	206685-003	Aug 15, 2018	AB3	RX	No	No
Mylan Labs Ltd	ESTRADIOL AND NORETHINDRONE ACETATE	estradiol; norethindrone acetate	TABLET;ORAL	207261-001	Feb 10, 2017	AB	RX	No	No
Therapeuticsmd Inc	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes			Y
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-005	May 27, 2003	AB2	RX	Yes	No

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
Allergan	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-002	Dec 20, 1996
Novartis	VIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020323-004	Oct 28, 1994
Bayer Hlthcare	CLIMARA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020375-004	Mar 5, 1999
Allergan	ALORA	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	020655-002	Dec 20, 1996

International Patents for estradiol

Country	Patent Number	Estimated Expiration
European Patent Office	1181930
Japan	2004513755
World Intellectual Property Organization (WIPO)	2008012071
Canada	2861346
South Korea	100856523

Supplementary Protection Certificates for estradiol

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1380301	CA 2009 00017	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
0770388	09C0018	France		PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
0771217	07C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
0770388	9/2009	Austria		PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103