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-nine 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.
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Questions you can ask:
- What is the 5 year forecast for VIVELLE?
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Summary for VIVELLE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 109 |
| Clinical Trials: | 4 |
| Patent Applications: | 4,058 |
| 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 |
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 | ⤷ 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 | estradiol | SYSTEM;TRANSDERMAL | 020323-003 | Oct 28, 1994 | DISCN | No | 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 | estradiol | SYSTEM;TRANSDERMAL | 020323-001 | Oct 28, 1994 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-002 | Oct 28, 1994 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Sandoz | VIVELLE-DOT | estradiol | SYSTEM;TRANSDERMAL | 020538-009 | May 3, 2002 | AB1 | RX | Yes | No | ⤷ 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-003 | Oct 28, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-003 | Oct 28, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-002 | Oct 28, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-005 | Aug 16, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-004 | Oct 28, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-005 | Aug 16, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Sandoz | VIVELLE | estradiol | SYSTEM;TRANSDERMAL | 020323-001 | Oct 28, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| European Patent Office | 0379045 | Système pour délivrer une drogue transdermique, à base d'un multipolymère acrylique. (Transdermal acrylic multipolymer drug delivery system.) | ⤷ Sign Up |
| European Patent Office | 0453505 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 9640086 | ⤷ Sign Up | |
| South Korea | 100363052 | ⤷ Sign Up | |
| Australia | 2004092 | ⤷ Sign Up | |
| Finland | 924313 | ⤷ Sign Up | |
| 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) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VIVELLE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 2782584 | 132021000000197 | Italy | ⤷ Sign Up | PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517 |
| 1380301 | 2009C/007 | Belgium | ⤷ Sign Up | PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811 |
| 1214076 | 49/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON; REGISTRATION NO/DATE: 1-27586 20080612 |
| 1214076 | SZ 49/2008 | Austria | ⤷ Sign Up | PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON |
| 0770388 | 2009/012 | Ireland | ⤷ Sign Up | PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103 |
| 0770388 | 09C0018 | France | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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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