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-nine 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:
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Summary for ESTRADERM
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Clinical Trials: | 2 |
| Patent Applications: | 4,086 |
| 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 | 019081-003 | 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 |
|---|---|---|---|
| Sweden | 8200892 | ⤷ Sign Up | |
| Spain | 407155 | ⤷ Sign Up | |
| Denmark | 140517 | ⤷ Sign Up | |
| Austria | 334545 | ⤷ 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 | 300814 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 0398460 | 12/2004 | Austria | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211 |
| 0136011 | 2000C/027 | Belgium | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
| 0136011 | 99C0003 | Belgium | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306 |
| >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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