VIVELLE-DOT Drug Patent Profile
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When do Vivelle-dot patents expire, 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 |
See drug prices for VIVELLE-DOT
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 |
| Nemours Children's Clinic | 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 |
| Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-009 | May 3, 2002 | ⤷ 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 |
|---|---|---|---|
| Singapore | 77626 | Compositions and methods for topical administration of pharmaceutically active agents | ⤷ Try a Trial |
| South Korea | 100391229 | ⤷ Try a Trial | |
| Austria | 99176 | ⤷ Try a Trial | |
| Israel | 112269 | Adhesive compositions for use in transdermal drug delivery systems and method of their preparation | ⤷ Try a Trial |
| New Zealand | 278769 | TRANSDERMAL DEVICE USING POLYVINYLPYRROLIDONE AS A SOLUBILITY ENHANCER | ⤷ Try a Trial |
| Argentina | 002355 | COMPOSICIONES Y METODOS PARA ADMINISTRACION LOCAL DE AGENTES FARMACEUTICAMENTE ACTIVOS. | ⤷ 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 |
|---|---|---|---|---|
| 0334429 | 97C0002 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305 |
| 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 |
| 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 | 301153 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406 |
| 0136011 | C00136011/03 | Switzerland | ⤷ Try a Trial | PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417 |
| 0771217 | 07C0001 | France | ⤷ Try a Trial | PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.
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