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.
AI Research Assistant
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 |
![ESTRADERM drug patent expirations Drug patent expirations by year for ESTRADERM](/p/graph/s/t/ESTRADERM-patent-expirations.png)
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 |