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Estradiol - Generic Drug Details
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This ingredient has one hundred and seventy-eight patent family members in thirty-four countries.
There are seventy-four drug master file entries for estradiol. Forty-two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for Generic Name: estradiol
| Tradenames: | 38 |
| Patents: | 18 |
| Applicants: | 38 |
| NDAs: | 57 |
| Drug Master File Entries: see list | 74 |
| Suppliers / Packaging: see list | 42 |
| Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers) |
| Drug Prices: | see low prices |
Pharmacology for Ingredient: estradiol
| Ingredient-type | Estradiol Congeners |
| Drug Class | Estrogen |
| Mechanism of Action | Estrogen Receptor Agonists |
Tentative approvals for ESTRADIOL
| Applicant | Application No. | Form | Dosage |
| <disabled> | <disabled> | TABLET;ORAL | 1MG;2MG;2MG |
| <disabled> | <disabled> | TABLET;ORAL | 3MG;2MG;3MG |
Clinical Trials for: estradiol
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Type | RLD | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | ESTRADERM | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 019081-003 | Sep 10, 1986 | RX | Yes | ||||||||||||||||||||||
Women First Hlthcare | ESCLIM | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020847-001 | Aug 4, 1998 | DISCN | No | ||||||||||||||||||||||
Novartis | VIVELLE-DOT | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020538-006 | Jan 8, 1999 | RX | No | ||||||||||||||||||||||
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Expired Orange Book Patents for Generic Ingredient: estradiol
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan Sales Llc | ALORA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020655-004 | Apr 5, 2002 | 5,164,190 | <disabled> | ||||||||||||||||||||||
Allergan Sales Llc | ALORA | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 020655-004 | Apr 5, 2002 | 5,122,383 | <disabled> | ||||||||||||||||||||||
Novartis | ESTRADERM | estradiol | FILM, EXTENDED RELEASE;TRANSDERMAL | 019081-003 | Sep 10, 1986 | 4,379,454 | <disabled> | ||||||||||||||||||||||
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Non-Orange Book Patents for Generic Ingredient: estradiol
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,916,486 | Transdermal delivery of analgesics | <disabled in preview> | |||||||||||||||||||||||||||
| 8,652,491 | Transdermal compositions for anticholinergic agents | <disabled in preview> | |||||||||||||||||||||||||||
| 7,214,381 | Composition for transdermal and/or transmucosal administration of active compounds that ensures adequate therapeutic levels | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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International Patent Family for Ingredient: estradiol
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Japan | 2000504697 | <disabled in preview> | |||||||||||||||||||||||||||
| Japan | 2004083599 | <disabled in preview> | |||||||||||||||||||||||||||
| European Patent Office | 1307232 | <disabled in preview> | |||||||||||||||||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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Supplementary Protection Certificates for Tradename: ESTRADIOL
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2012 00011 | Denmark | <disabled> | |||||||||||||||||||||||||||
| 00522 | Netherlands | <disabled> | PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006 | ||||||||||||||||||||||||||
| C/GB04/032 | United Kingdom | <disabled> | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 | ||||||||||||||||||||||||||
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How are People Using DrugPatentWatch?
To find molecules near to the expiration of their patent rights
— Pharmceutical sales, India
To confirm freedom to operate for drugs
— Drug development consultant, USA
For drug patent expirations and intelligence
— Analyst, USA
To research drug patent expirations and NCE dates
— Patent attorney, USA
Want to know data of final approval and tentative approval of drugs launched in the US market
— Pharmaceutical executive, USA
For information on medications and their innovator companies, as well as their patency profiles
— Pharmacist, Nigeria
To be informed abut patent protection and patent challenges
— Business development / Licensing / Marketing & sales, Italy
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 verifification 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.
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