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Last Updated: August 11, 2020

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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 Pharms Llc, 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-eight 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.

Drug Prices for ESTRADIOL

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Drug Sales Revenue Trends for ESTRADIOL

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Recent Clinical Trials for ESTRADIOL

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SponsorPhase
Assiut UniversityEarly Phase 1
Colorado Center for Reproductive MedicineEarly Phase 1
AbbVieEarly Phase 1

See all ESTRADIOL clinical trials

Generic filers with tentative approvals for ESTRADIOL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial3MG;2MG;3MGTABLET;ORAL
  Start Trial  Start Trial1MG;2MG;2MGTABLET;ORAL
  Start Trial  Start Trial0.1MG/24HRFILM, 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 ClassEstrogen
Mechanism of ActionEstrogen Receptor Agonists
Medical Subject Heading (MeSH) Categories for ESTRADIOL
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
Bayer Hlthcare CLIMARA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020375-006 May 27, 2003 AB RX Yes No   Start Trial   Start Trial   Start Trial
Noven MINIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 203752-003 Oct 29, 2012 AB3 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-003 Dec 20, 1996 BX RX No No   Start Trial   Start Trial   Start Trial
Usl Pharma ESTRADIOL estradiol TABLET;ORAL 040297-001 Apr 17, 2002 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan Technologies ESTRADIOL estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 201675-001 Dec 19, 2014 AB1 RX No No   Start Trial   Start Trial   Start 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Women First Hlthcare ESCLIM estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020847-003 Aug 4, 1998   Start Trial   Start Trial
Allergan ALORA estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020655-001 Dec 20, 1996   Start Trial   Start Trial
Novartis VIVELLE estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020323-001 Oct 28, 1994   Start Trial   Start Trial
Novartis ESTRADERM estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 019081-003 Sep 10, 1986   Start Trial   Start Trial
Novartis VIVELLE-DOT estradiol FILM, EXTENDED RELEASE;TRANSDERMAL 020538-007 Jan 8, 1999   Start Trial   Start Trial
>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
0770388 PA2009004 Lithuania   Start 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
0285237 95C0008 Belgium   Start Trial PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
1453521 15C0050 France   Start 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
1453521 39/2015 Austria   Start Trial PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
0770388 09C0018 France   Start Trial PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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