VIVELLE-DOT Drug Patent Profile
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Which patents cover Vivelle-dot, and what generic alternatives are available?
Vivelle-dot is a drug marketed by Sandoz and is included in one NDA.
The generic ingredient in VIVELLE-DOT 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-dot
A generic version of VIVELLE-DOT was approved as estradiol by BARR LABS INC on October 22nd, 1997.
Summary for VIVELLE-DOT
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 109 |
Clinical Trials: | 4 |
Patent Applications: | 4,318 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for VIVELLE-DOT |
Drug Sales Revenues: | Drug sales revenues for VIVELLE-DOT |
What excipients (inactive ingredients) are in VIVELLE-DOT? | VIVELLE-DOT excipients list |
DailyMed Link: | VIVELLE-DOT at DailyMed |
Recent Clinical Trials for VIVELLE-DOT
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 |
Pharmacology for VIVELLE-DOT
Drug Class | Estrogen |
Mechanism of Action | Estrogen Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for VIVELLE-DOT
Paragraph IV (Patent) Challenges for VIVELLE-DOT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
VIVELLE-DOT | Transdermal System | estradiol | 0.025 mg/day 0.0375 mg/day 0.05 mg/days 0.075 mg/day 0.1 mg/day | 020538 | 1 | 2010-04-27 |
US Patents and Regulatory Information for VIVELLE-DOT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-009 | May 3, 2002 | AB1 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-007 | Jan 8, 1999 | AB1 | RX | Yes | 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-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-006 | Jan 8, 1999 | AB1 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-008 | Jan 8, 1999 | AB1 | RX | Yes | Yes | ⤷ 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-DOT
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-005 | Jan 8, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-009 | May 3, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-009 | May 3, 2002 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-006 | Jan 8, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-006 | Jan 8, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VIVELLE-DOT
See the table below for patents covering VIVELLE-DOT 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-DOT
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 |