ESTRADERM Drug Patent Profile
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When do Estraderm patents expire, and what generic alternatives are available?
Estraderm is a drug marketed by Novartis and is included in one NDA.
The generic ingredient in ESTRADERM is estradiol. There are seventy-five drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the estradiol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Estraderm
A generic version of ESTRADERM was approved as estradiol by BARR LABS INC on October 22nd, 1997.
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Questions you can ask:
- What is the 5 year forecast for ESTRADERM?
- What are the global sales for ESTRADERM?
- What is Average Wholesale Price for ESTRADERM?
Summary for ESTRADERM
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Clinical Trials: | 2 |
| Patent Applications: | 4,118 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | ESTRADERM at DailyMed |
Recent Clinical Trials for ESTRADERM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute on Aging (NIA) | Phase 1/Phase 2 |
| Massachusetts General Hospital | Phase 1/Phase 2 |
| Massachusetts General Hospital | Phase 2/Phase 3 |
US Patents and Regulatory Information for ESTRADERM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | ESTRADERM | estradiol | SYSTEM;TRANSDERMAL | 019081-002 | Sep 10, 1986 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | ESTRADERM | estradiol | SYSTEM;TRANSDERMAL | 019081-003 | Sep 10, 1986 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 ESTRADERM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | ESTRADERM | estradiol | SYSTEM;TRANSDERMAL | 019081-003 | Sep 10, 1986 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | ESTRADERM | estradiol | SYSTEM;TRANSDERMAL | 019081-002 | Sep 10, 1986 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | ESTRADERM | estradiol | SYSTEM;TRANSDERMAL | 019081-002 | Sep 10, 1986 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | ESTRADERM | estradiol | SYSTEM;TRANSDERMAL | 019081-003 | Sep 10, 1986 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | ESTRADERM | estradiol | SYSTEM;TRANSDERMAL | 019081-003 | Sep 10, 1986 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | ESTRADERM | estradiol | SYSTEM;TRANSDERMAL | 019081-002 | Sep 10, 1986 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ESTRADERM
See the table below for patents covering ESTRADERM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Switzerland | 576794 | ⤷ Sign Up | |
| Germany | 2135533 | ⤷ Sign Up | |
| France | 2499859 | DISPOSITIF D'ADMINISTRATION SIMULTANEE D'UNE SUBSTANCE PHARMACEUTIQUE ET D'UN ACTIVATEUR D'ABSORPTION PERCUTANEE | ⤷ Sign Up |
| Hong Kong | 90687 | DOSAGE FORM FOR COADMINISTERING DRUG AND PERCUTANEOUS ABSORPTION ENHANCER | ⤷ Sign Up |
| Spain | 171385 | ⤷ Sign Up | |
| United Kingdom | 2093694 | DOSAGE FORM FOR COADMINISTERING DRUG AND PERCUTANEOUS ABSORPTION ENHANCER | ⤷ Sign Up |
| Austria | A626171 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ESTRADERM
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0770388 | PA2009004,C0770388 | Lithuania | ⤷ Sign Up | 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 |
| 0770388 | SPC/GB09/026 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208 |
| 1453521 | 93156 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211 |
| 0584952 | 99C0004 | Belgium | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306 |
| 1380301 | CA 2009 00017 | Denmark | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
| 2782584 | C202130068 | Spain | ⤷ Sign Up | 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 |
| 0398460 | 04C0022 | France | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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