VIVELLE-DOT Drug Patent Profile
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Which patents cover Vivelle-dot, and when can generic versions of Vivelle-dot launch?
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-five 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 | 020538-009 | 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 | 020538-008 | Jan 8, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-005 | Jan 8, 1999 | ⤷ Try a Trial | ⤷ Try a Trial |
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-008 | 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 |
---|---|---|---|
European Patent Office | 0634179 | ⤷ Try a Trial | |
Finland | 110994 | ⤷ Try a Trial | |
Portugal | 92830 | DISPOSITIVO ADESIVO PARA APLICACAO DERMICA | ⤷ Try a Trial |
Finland | 935833 | ⤷ Try a Trial | |
Japan | 4474375 | ⤷ 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 | C 2015 029 | Romania | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129 |
1453521 | 300814 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211 |
2782584 | C202130068 | Spain | ⤷ Try a Trial | PRODUCT NAME: COMPOSICION QUE CONTIENE ESTRADIOL (17BETA-ESTRADIOL), INCLUYENDO EN FORMA DE HEMIHIDRATO, Y PROGESTERONA; NATIONAL AUTHORISATION NUMBER: 85988-NL/H/4994/001/DC; DATE OF AUTHORISATION: 20210528; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): BE582231; DATE OF FIRST AUTHORISATION IN EEA: 20210406 |
0770388 | SPC/GB09/026 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208 |
0770388 | 2009/012 | Ireland | ⤷ Try a Trial | PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |