ULTIVA Drug Patent Profile
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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. Three suppliers are listed for this compound. Additional details are available on the remifentanil hydrochloride profile page.
DrugPatentWatch® 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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 39 |
| Clinical Trials: | 98 |
| Patent Applications: | 4,195 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ULTIVA |
| What excipients (inactive ingredients) are in ULTIVA? | ULTIVA excipients list |
| DailyMed Link: | ULTIVA at DailyMed |
Recent Clinical Trials for ULTIVA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Medical Center Groningen | Phase 1 |
| QPS | Phase 1 |
| Paion UK Ltd. | Phase 1 |
Pharmacology for ULTIVA
| Drug Class | Opioid Agonist |
| Mechanism of Action | Full Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for ULTIVA
Paragraph IV (Patent) Challenges for ULTIVA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ULTIVA | for Injection | remifentanil hydrochloride | 1 mg/vial, 2 mg/vial and 5 mg/vial | 020630 | 1 | 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-002 | Jul 12, 1996 | AP | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-003 | Jul 12, 1996 | AP | 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 ULTIVA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-001 | Jul 12, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-003 | Jul 12, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-003 | Jul 12, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-003 | Jul 12, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-002 | Jul 12, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ULTIVA
See the table below for patents covering ULTIVA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Mexico | 9203024 | N-FENIL-N-(4-PIPERIDINIL)AMIDAS Y COMPOSICIONES FARMACEUTICAS QUE LAS CONTIENEN. | ⤷ Try a Trial |
| Denmark | 0383579 | ⤷ Try a Trial | |
| Germany | 19675028 | ⤷ Try a Trial | |
| Germany | 69027794 | ⤷ Try a Trial | |
| Luxembourg | 90011 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ULTIVA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0383579 | SZ 34/1996 | Austria | ⤷ Try a Trial | PRODUCT NAME: REMIFENTANIL UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SAEUREADDITIONSSALZE, EINSCHLIESSLICH REMIFENTANIL-HYDROCHLORID |
| 0383579 | 97C0029 | Belgium | ⤷ Try a 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 | 19675028 | Germany | ⤷ Try a 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 | SPC/GB96/059 | United Kingdom | ⤷ Try a 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 |
| 0383579 | C960030 | Netherlands | ⤷ Try a 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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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