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, Solaris Pharma Corp, Ascend Theraps Us, Vertical Pharms, Chemo Research Sl, Novitium Pharma, Quagen, 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, Norvium Bioscience, Usl Pharma, Duramed Pharms Barr, Novo Nordisk Inc, Amneal Pharms, Aurobindo Pharma, Glenmark Pharms Ltd, Millicent, Apil, Dr Reddys, Pharmacia And Upjohn, Watson Labs, Exeltis Usa Inc, Endo Operations, Am Regent, Fosun Pharma, Hikma, Xiromed, Savage Labs, Noven Pharms Inc, Lupin Ltd, Barr, Breckenridge Pharm, Naari Pte Ltd, Novast Labs, Aurobindo Pharma Ltd, Sumitomo Pharma, and Teva Womens, and is included in eighty-eight NDAs. There are fifty-six 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-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ESTRADIOL

International Patents:	185
US Patents:	56
Tradenames:	43
Applicants:	60
NDAs:	88
Drug Master File Entries:	75
Finished Product Suppliers / Packagers:	49
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	1,002
Patent Applications:	7,032
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
Anna Stanhewicz, PhD	Early Phase 1
McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4
Alexion Pharmaceuticals, Inc.	Phase 1

See all ESTRADIOL clinical trials

Generic filers with tentative approvals for ESTRADIOL

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	3MG;2MG;3MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	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	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Mayne Pharma	IMVEXXY	estradiol	INSERT;VAGINAL	208564-002	May 29, 2018		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Dr Reddys	ESTRADIOL CYPIONATE	estradiol cypionate	INJECTABLE;INJECTION	085620-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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-DOT	estradiol	SYSTEM;TRANSDERMAL	020538-008	Jan 8, 1999	⤷ Sign Up	⤷ Sign Up
Noven	MINIVELLE	estradiol	FILM, EXTENDED RELEASE;TRANSDERMAL	203752-003	Oct 29, 2012	⤷ Sign Up	⤷ Sign Up
Sandoz	VIVELLE	estradiol	SYSTEM;TRANSDERMAL	020323-005	Aug 16, 2000	⤷ Sign Up	⤷ Sign Up
Novo Nordisk Inc	VAGIFEM	estradiol	TABLET;VAGINAL	020908-002	Nov 25, 2009	⤷ Sign Up	⤷ Sign Up
>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	3007636		⤷ Sign Up
Uruguay	31975	SISTEMA Y ADMINISTRACIÓN TRANSDÉRMICA DE ESTRÓGENO	⤷ Sign Up
Japan	2019214598	天然の併用ホルモン補充療法剤及び治療 (NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES)	⤷ Sign Up
Brazil	112014012444		⤷ Sign Up
>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
1214076	C01214076/01	Switzerland	⤷ Sign Up	PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0285237	95C0008	Belgium	⤷ Sign Up	PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
0398460	04C0022	France	⤷ Sign Up	PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
0334429	97C0002	Belgium	⤷ Sign Up	PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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