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Last Updated: February 4, 2023

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-two 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, Chemo Research Sl, Pfizer, Therapeuticsmd Inc, Padagis Us, Women First Hlthcare, Novartis, Ortho Mcneil Pharm, Zydus Noveltech Inc, Bristol Myers Squibb, Barr Labs Inc, Epic Pharma, Lannett Co 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-seven NDAs. There are fifty-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 fifty-two patent family members in twenty-nine countries.

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

Drug Prices for estradiol

See drug prices for estradiol

Drug Sales Revenue Trends for estradiol

See drug sales revenues for estradiol

Recent Clinical Trials for estradiol

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Maryland, BaltimoreEarly Phase 1
Karolinska University HospitalN/A
CRG UZ BrusselN/A

See all estradiol clinical trials

Generic filers with tentative approvals for ESTRADIOL
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing3MG;2MG;3MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing1MG;2MG;2MGTABLET;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
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Padagis Us EVAMIST estradiol SPRAY;TRANSDERMAL 022014-001 Jul 27, 2007 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Mayne Pharma BIJUVA estradiol; progesterone CAPSULE;ORAL 210132-001 Oct 28, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare CLIMARA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020375-002 Dec 22, 1994 See Plans and Pricing See Plans and Pricing
Pfizer ESTRING estradiol INSERT, EXTENDED RELEASE;VAGINAL 020472-001 Apr 26, 1996 See Plans and Pricing See Plans and Pricing
Allergan ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-003 Dec 20, 1996 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for estradiol

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1380301 CA 2009 00017 Denmark See Plans and Pricing PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
0771217 CA 2006 00038 Denmark See Plans and Pricing PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0398460 12/2004 Austria See Plans and Pricing PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Medtronic

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