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Last Updated: October 17, 2021

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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.

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
Assiut UniversityN/A
Washington University School of MedicinePhase 3
Beijing University of Chinese MedicinePhase 4

See all estradiol clinical trials

Generic filers with tentative approvals for ESTRADIOL
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free3MG;2MG;3MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free1MG;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 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 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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Mylan Labs Ltd ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 207261-002 Feb 10, 2017 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Padagis Us EVAMIST estradiol SPRAY;TRANSDERMAL 022014-001 Jul 27, 2007 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Naari Pte Ltd ESTRADIOL AND NORETHINDRONE ACETATE estradiol; norethindrone acetate TABLET;ORAL 210233-001 Feb 28, 2018 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Par Sterile Products DELESTROGEN estradiol valerate INJECTABLE;INJECTION 009402-002 Approved Prior to Jan 1, 1982 AO RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Therapeuticsmd Inc IMVEXXY estradiol INSERT;VAGINAL 208564-002 May 29, 2018 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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
Novartis VIVELLE estradiol SYSTEM;TRANSDERMAL 020323-004 Oct 28, 1994 ⤷  Try it Free ⤷  Try it Free
Novartis VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-007 Jan 8, 1999 ⤷  Try it Free ⤷  Try it Free
Novartis VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-006 Jan 8, 1999 ⤷  Try it Free ⤷  Try it Free
Novartis VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-005 Jan 8, 1999 ⤷  Try it Free ⤷  Try it Free
Novartis VIVELLE-DOT estradiol SYSTEM;TRANSDERMAL 020538-008 Jan 8, 1999 ⤷  Try it Free ⤷  Try it Free
Padagis Us EVAMIST estradiol SPRAY;TRANSDERMAL 022014-001 Jul 27, 2007 ⤷  Try it Free ⤷  Try it Free
>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 ⤷  Try it Free 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 ⤷  Try it Free PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
0402407 97C0005 Belgium ⤷  Try it Free 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 ⤷  Try it Free PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
1453521 93156 Luxembourg ⤷  Try it Free PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1453521 CA 2016 00016 Denmark ⤷  Try it Free PRODUCT NAME: LEVONORGESTREL OG ETHINYLOESTRADIOL; NAT. REG. NO/DATE: 56336 20151105; FIRST REG. NO/DATE: SK 17/0017/15-S 20150211
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Moodys
McKinsey
McKesson
Medtronic

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