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VIVELLE Drug Profile
» See Plans and Pricing
When do Vivelle patents expire, and what generic alternatives are available?
Vivelle is a drug marketed by Novartis and is included in two NDAs.
The generic ingredient in VIVELLE is estradiol. There are seventy-five drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the estradiol profile page.
US ANDA Litigation and Generic Entry Outlook for Vivelle
A generic version of VIVELLE was approved as estradiol by MAYNE PHARMA on March 14th, 1996.
Summary for VIVELLE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Bulk Api Vendors: | 96 |
| Clinical Trials: | 4 |
| Patent Applications: | 3,935 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-005 | Aug 16, 2000 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Novartis | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-005 | Jan 8, 1999 | AB1 | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Novartis | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-003 | Oct 28, 1994 | DISCN | No | No | Start Trial | Start Trial | Start 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 VIVELLE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-004 | Oct 28, 1994 | Start Trial | Start Trial |
| Novartis | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-003 | Oct 28, 1994 | Start Trial | Start Trial |
| Novartis | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-001 | Oct 28, 1994 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VIVELLE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Australia | 700429 | Start Trial |
| Brazil | 9206208 | Start Trial |
| Netherlands | 9020171 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VIVELLE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1453521 | 39/2015 | Austria | Start Trial | PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
| 1453521 | C201630040 | Spain | Start Trial | 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 |
| 0770388 | 9/2009 | Austria | Start Trial | PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
