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-seven 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for VIVELLE-DOT?
- What are the global sales for VIVELLE-DOT?
- What is Average Wholesale Price for VIVELLE-DOT?
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: | 4,118 |
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 |
![VIVELLE-DOT drug patent expirations Drug patent expirations by year for VIVELLE-DOT](/p/graph/s/t/VIVELLE-DOT-patent-expirations.png)
![Drug Prices for VIVELLE-DOT](/p/graph/drug-price/VIVELLE-DOT.png)
See drug prices for VIVELLE-DOT
![Drug Sales Revenue Trends for VIVELLE-DOT](/p/graph/drug-sales-revenues/VIVELLE-DOT.png)
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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-007 | Jan 8, 1999 | AB1 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-005 | Jan 8, 1999 | AB1 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-006 | Jan 8, 1999 | AB1 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-008 | Jan 8, 1999 | AB1 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | 020538-006 | Jan 8, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-008 | Jan 8, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-005 | Jan 8, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-005 | Jan 8, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-008 | Jan 8, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-008 | Jan 8, 1999 | ⤷ Sign Up | ⤷ Sign Up |
Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-009 | May 3, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Finland | 924313 | ⤷ Sign Up | |
Austria | 122240 | ⤷ Sign Up | |
Japan | H04504515 | ⤷ Sign Up | |
Hong Kong | 1006285 | ⤷ Sign Up | |
Singapore | 49331 | Solubility parameter based pvp drug delivery system and methods therefor | ⤷ Sign Up |
Brazil | 9506470 | COMPOSIÇÃO ADESIVA SENSÍVEL À PRESSÃO E SISTEMA DE DISTRIBUIÇÃO TRANSDÉRMICA DE DROGA. | ⤷ Sign Up |
Hungary | T75462 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VIVELLE-DOT
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0136011 | 2000C/027 | Belgium | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124 |
1453521 | C 2015 029 | Romania | ⤷ Sign Up | 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 | 132016000025143 | Italy | ⤷ Sign Up | PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414 |
1380301 | CA 2009 00017 | Denmark | ⤷ Sign Up | PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629 |
0770388 | 09C0018 | France | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103 |
0398460 | C300221 | Netherlands | ⤷ Sign Up | PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307 |
0398460 | SPC/GB04/032 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |