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-five 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 |
---|---|
National Institute on Aging (NIA) | Phase 1/Phase 2 |
Massachusetts General Hospital | 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Novartis | ESTRADERM | estradiol | SYSTEM;TRANSDERMAL | 019081-003 | Sep 10, 1986 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 ESTRADERM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | ESTRADERM | estradiol | SYSTEM;TRANSDERMAL | 019081-002 | Sep 10, 1986 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | ESTRADERM | estradiol | SYSTEM;TRANSDERMAL | 019081-003 | Sep 10, 1986 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | ESTRADERM | estradiol | SYSTEM;TRANSDERMAL | 019081-002 | Sep 10, 1986 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Italy | 1218310 | UNITA DI DOSAGGIO PER LA SOMMINISTRAZIONE CONTEMPORANEA DI UN MEDICAMNETO E DI INTENSIFICATORE DI ASSORBIMENTO PERCUTANEO | ⤷ Try a Trial |
Australia | 547007 | ⤷ Try a Trial | |
Malaysia | 8700746 | DOSAGE FORM FOR COADMINISTERING DRUG PERCUTANEOUS ABSORPTION ENHANCER | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ESTRADERM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1214076 | 49/2008 | Austria | ⤷ Try a Trial | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
2782584 | 21C1058 | France | ⤷ Try a Trial | PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17SS-ESTRADIOL), Y COMPRIS SOUS FORME HEMIHYDRATEE, ET DE LA PROGESTERONE; NAT. REGISTRATION NO/DATE: NL51886 20210421; FIRST REGISTRATION: BE - BE582231 20210406 |
0136011 | C00136011/03 | Switzerland | ⤷ Try a Trial | PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |