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-six 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.
Summary for VIVELLE
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 4 |
Patent Applications: | 5,371 |
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 |
Genentech, Inc. | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for VIVELLE
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-005 | Jan 8, 1999 | AB1 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-003 | Oct 28, 1994 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-006 | Jan 8, 1999 | AB1 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-001 | Oct 28, 1994 | DISCN | No | 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 VIVELLE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-001 | Oct 28, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-005 | Aug 16, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-005 | Aug 16, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-002 | Oct 28, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-002 | Oct 28, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Canada | 2110914 | SYSTEME DE DELIVRANCE DE MEDICAMENTS BASE SUR LES PARAMETRES DE SOLUBILITE ET METHODE POUR MODIFIER LE TAUX DE SATURATION D'UN MEDICAMENT (SOLUBILITY PARAMETER BASED DRUG DELIVERY SYSTEM AND METHOD FOR ALTERING DRUG SATURATION CONCENTRATION) | ⤷ Try a Trial |
Brazil | 9206208 | ⤷ Try a Trial | |
Spain | 2196055 | ⤷ Try a Trial | |
Japan | 2659837 | ⤷ Try a Trial | |
European Patent Office | 0728477 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VIVELLE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1453521 | C201630040 | Spain | ⤷ Try a 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 |
0136011 | 99C0003 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306 |
2782584 | 122021000080 | Germany | ⤷ Try a Trial | 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 |
1453521 | 132016000025143 | Italy | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414 |
0398460 | C300221 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |