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ULTIVA Drug Profile
» See Plans and Pricing
Which patents cover Ultiva, and what generic alternatives are available?
Ultiva is a drug marketed by Mylan Institutional and is included in one NDA.
The generic ingredient in ULTIVA is remifentanil hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the remifentanil hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Ultiva
A generic version of ULTIVA was approved as remifentanil hydrochloride by FRESENIUS KABI USA on January 16th, 2018.
Summary for ULTIVA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 29 |
| Clinical Trials: | 94 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ULTIVA |
| DailyMed Link: | ULTIVA at DailyMed |
Recent Clinical Trials for ULTIVA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Helse Fonna | Phase 4 |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Phase 2 |
| University Hospital, Akershus | Phase 4 |
Pharmacology for ULTIVA
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Paragraph IV (Patent) Challenges for ULTIVA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ULTIVA | INJECTABLE;INJECTION | remifentanil hydrochloride | 020630 | 2013-12-27 |
US Patents and Regulatory Information for ULTIVA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-001 | Jul 12, 1996 | AP | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-002 | Jul 12, 1996 | AP | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-003 | Jul 12, 1996 | AP | RX | Yes | Yes | Start Trial | Start Trial | Start 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 ULTIVA
International Patents for ULTIVA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 19675028 | Start Trial |
| Ireland | 900532 | Start Trial |
| Germany | 69027794 | Start Trial |
| Luxembourg | 90011 | Start Trial |
| Ireland | 77156 | Start Trial |
| Austria | 140451 | Start Trial |
| Denmark | 0383579 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ULTIVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0383579 | SZ 34/1996 | Austria | Start Trial | PRODUCT NAME: REMIFENTANIL UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SAEUREADDITIONSSALZE, EINSCHLIESSLICH REMIFENTANIL-HYDROCHLORID |
| 0383579 | C960030 | Netherlands | Start Trial | PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517 |
| 0383579 | 19675028 | Germany | Start Trial | PRODUCT NAME: REMIFENTANIL SOWIE PHARMAZEUTISCH ANNEHMBARE SAEUREADDITIONSSALZE DAVON, EINSCHLIESSLICH REMIFENTANILHYDROCHLORID; REGISTRATION NO/DATE: 36335.00.00 36335.01.00 36335.02.00 19960517 |
| 0383579 | 97C0029 | Belgium | Start Trial | PRODUCT NAME: REMIFENTANILUM HYDROCHLORIDUM (= REMIFENTANILUM BASIS); NAT. REGISTRATION NO/DATE: 725 IS 146 F 12 19970408; FIRST REGISTRATION: DE 36.335.00.00 19960517 |
| 0383579 | SPC/GB96/059 | United Kingdom | Start Trial | PRODUCT NAME: REMIFENTANIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT, INCLUDING REMIFENTANIL HYDROCHLORIDE; REGISTERED: DE 36335.00.00 19960517; DE 36335.01.00 19960517; DE 36335.02.00 19960517; UK 14213/0002 19961030; UK 14213/0003 19961030; UK 14213/0004 19961030 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
