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-six 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.
Summary for ESTRADERM
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 2 |
Patent Applications: | 6,502 |
Formulation / Manufacturing: | see details |
DailyMed Link: | ESTRADERM at DailyMed |
Recent Clinical Trials for ESTRADERM
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Massachusetts General Hospital | Phase 1/Phase 2 |
National Institute on Aging (NIA) | Phase 1/Phase 2 |
Massachusetts General Hospital | Phase 2/Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for ESTRADERM
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 | 019081-002 | 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 |
Novartis | ESTRADERM | estradiol | SYSTEM;TRANSDERMAL | 019081-003 | 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 |
---|---|---|---|
United Kingdom | 1333576 | ⤷ Sign Up | |
Netherlands | 166851 | ⤷ Sign Up | |
Canada | 930668 | BANDAGE FOR ADMINISTERING DRUGS | ⤷ Sign Up |
Canada | 993358 | DRUG-DELIVERY SYSTEM | ⤷ Sign Up |
Denmark | 131805 | ⤷ Sign Up | |
Sweden | 396695 | ANORDNING FOR FRIGORANDE AV ETT AKTIVT MEDEL I EN REGLERAD MENGD PER TIDSENHET UNDER LENGRE TIDSPERIODER | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ESTRADERM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1453521 | 15C0050 | France | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129 |
2782584 | 2021C/558 | Belgium | ⤷ Sign Up | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406 |
2861072 | 2024C/512 | Belgium | ⤷ Sign Up | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL, EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE (Y COMPRIS SOUS FORME HEMIHYDRATEE) ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406 |
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 |
1453521 | 122015000093 | Germany | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129 |
0771217 | CA 2006 00038 | Denmark | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |