ESTRADIOL - Generic Drug Details
✉ Email this page to a colleague
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, Ascend Theraps Us, Vertical Pharms, Chemo Research Sl, Novitium Pharma, 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, 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, Xiromed, Savage Labs, Noven Pharms Inc, Lupin Ltd, Barr, Breckenridge Pharm, Mylan Labs Ltd, Naari Pte Ltd, Novast Labs, Aurobindo Pharma Ltd, Myovant Sciences, and Teva Womens, and is included in eighty-four NDAs. There are fifty-five 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-three patent family members in twenty-six countries.
There are seventy-five drug master file entries for estradiol. Forty-six suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for ESTRADIOL
International Patents: | 183 |
US Patents: | 55 |
Tradenames: | 43 |
Applicants: | 57 |
NDAs: | 84 |
Drug Master File Entries: | 75 |
Finished Product Suppliers / Packagers: | 46 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 987 |
Patent Applications: | 6,728 |
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 |
Recent Clinical Trials for ESTRADIOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Gary Schwartz | Phase 1 |
Dartmouth-Hitchcock Medical Center | Phase 1 |
Beni-Suef University | Phase 2/Phase 3 |
Generic filers with tentative approvals for ESTRADIOL
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 3MG;2MG;3MG | TABLET;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-001 | Oct 28, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Zydus Pharms | ESTRADIOL | estradiol | SYSTEM;TRANSDERMAL | 204379-001 | Apr 17, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan | ESTRADIOL | estradiol | TABLET;ORAL | 040326-003 | Apr 21, 1999 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mayne Pharma | IMVEXXY | estradiol | INSERT;VAGINAL | 208564-002 | May 29, 2018 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Mayne Pharma | BIJUVA | estradiol; progesterone | CAPSULE;ORAL | 210132-002 | Dec 28, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a 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 |
---|---|---|---|---|---|---|---|
Abbvie | ALORA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020655-002 | Dec 20, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | ALORA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020655-004 | Apr 5, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | ESTRADERM | estradiol | SYSTEM;TRANSDERMAL | 019081-002 | Sep 10, 1986 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-001 | Oct 28, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-008 | Jan 8, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ESTRADIOL
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Lithuania | 2782584 | ⤷ Try a Trial | |
Japan | 2011527697 | ⤷ Try a Trial | |
Russian Federation | 2740059 | КАПСУЛЫ С РАСТВОРИМЫМ ЭСТРАДИОЛОМ ДЛЯ ИНТРАВАГИНАЛЬНОГО ВВЕДЕНИЯ (CAPSULES WITH SOLUBLE OESTRADIOL FOR INTRAVAGINAL INTRODUCTION) | ⤷ Try a Trial |
Japan | 6285866 | ⤷ Try a Trial | |
Australia | 2021240253 | Natural Combination Hormone Replacement Formulations And Therapies | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ESTRADIOL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2782584 | 301153 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406 |
1214076 | C01214076/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008 |
0136011 | 99C0003 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306 |
1453521 | 300814 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
2782584 | C202130068 | Spain | ⤷ Try a Trial | PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.