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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-one branded drugs marketed by Allergan, Alvogen, Mylan, Padagis Israel, Prasco Labs Llc, Teva Pharms Usa, Bayer Hlthcare, Amneal, Mylan Technologies, Parke Davis, Noven, Mylan Speciality Lp, Ascend Theraps Us, Vertical Pharms Llc, Pfizer, Therapeuticsmd Inc, Padagis Us, Women First Hlthcare, Novartis, Ortho Mcneil Pharm, 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, Pharmacia And Upjohn, 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, Myovant Sciences, and Teva Womens, and is included in seventy-four NDAs. There are forty-three 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 thirty-one patent family members in twenty-eight countries.

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

Summary for estradiol

International Patents:	231
US Patents:	43
Tradenames:	41
Applicants:	50
NDAs:	74
Drug Master File Entries:	75
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	903
Patent Applications:	6,369
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
Assiut University	N/A
Washington University School of Medicine	Phase 3
Beijing University of Chinese Medicine	Phase 4

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

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	SYSTEM;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
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004		DISCN	Yes	No			Y
Mylan Labs Ltd	ESTRADIOL AND NORETHINDRONE ACETATE	estradiol; norethindrone acetate	TABLET;ORAL	207261-002	Feb 10, 2017	AB	RX	No	No
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007		RX	Yes	Yes			Y
Naari Pte Ltd	ESTRADIOL AND NORETHINDRONE ACETATE	estradiol; norethindrone acetate	TABLET;ORAL	210233-001	Feb 28, 2018		DISCN	No	No
Par Sterile Products	DELESTROGEN	estradiol valerate	INJECTABLE;INJECTION	009402-002	Approved Prior to Jan 1, 1982	AO	RX	Yes	Yes
Therapeuticsmd Inc	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018		RX	Yes	Yes

Expired US Patents for estradiol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-004	Oct 28, 1994
Novartis	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-007	Jan 8, 1999
Novartis	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-006	Jan 8, 1999
Novartis	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-005	Jan 8, 1999
Novartis	VIVELLE-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-008	Jan 8, 1999
Padagis Us	EVAMIST	estradiol	SPRAY;TRANSDERMAL	022014-001	Jul 27, 2007

International Patents for estradiol

Country	Patent Number	Estimated Expiration
European Patent Office	1323430
Japan	6285866
Mexico	PA05008648
European Patent Office	1307232
Japan	2015507607
Japan	6118774

Supplementary Protection Certificates for estradiol

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	PA2009004	Lithuania		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
0136011	99C0003	Belgium		PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
0402407	97C0005	Belgium		PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
0136011	2000C/027	Belgium		PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521	CA 2016 00016	Denmark		PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211