VIVELLE Drug Patent Profile
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When do Vivelle patents expire, and what generic alternatives are available?
Vivelle is a drug marketed by Sandoz and is included in two NDAs.
The generic ingredient in VIVELLE 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 Vivelle
A generic version of VIVELLE 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 VIVELLE?
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- What is Average Wholesale Price for VIVELLE?
Summary for VIVELLE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Clinical Trials: | 4 |
| Patent Applications: | 4,124 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VIVELLE |
| Drug Sales Revenues: | Drug sales revenues for VIVELLE |
| DailyMed Link: | VIVELLE at DailyMed |
Recent Clinical Trials for VIVELLE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Early Phase 1 |
| University of Virginia | Early Phase 1 |
| Nemours Children's Clinic | Phase 4 |
US Patents and Regulatory Information for VIVELLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-005 | Aug 16, 2000 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-005 | Jan 8, 1999 | AB1 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-003 | Oct 28, 1994 | DISCN | No | 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 VIVELLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-002 | Oct 28, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-004 | Oct 28, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-001 | Oct 28, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VIVELLE
See the table below for patents covering VIVELLE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 923699 | ⤷ Sign Up | |
| Australia | 632534 | ⤷ Sign Up | |
| Finland | 121527 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VIVELLE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 1453521 | C201630040 | Spain | ⤷ Sign Up | PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211 |
| 2782584 | 122021000080 | Germany | ⤷ Sign Up | PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; NAT. REGISTRATION NO/DATE: 2205034.00.00 20210924; FIRST REGISTRATION: BELGIEN BE582231 20210406 |
| >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.
ISSN: 2162-2639
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