ULTIVA Drug Patent Profile
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When do Ultiva patents expire, 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: | 45 |
Clinical Trials: | 98 |
Patent Applications: | 4,190 |
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 |
---|---|
QPS | Phase 1 |
Paion UK Ltd. | Phase 1 |
University Medical Center Groningen | 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-002 | Jul 12, 1996 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-003 | Jul 12, 1996 | AP | 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 ULTIVA
International Patents for ULTIVA
See the table below for patents covering ULTIVA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 93137 | PROCESSO PARA A PREPARACAO DE N-FENIL-N-(4-PIPERIDINIL) AMIDAS | ⤷ Sign Up |
Denmark | 0383579 | ⤷ Sign Up | |
European Patent Office | 0383579 | N-Phényl N-(pipéridinyl-4)amides utiles comme analgésiques (N-Phenyl-N-(4-piperidinyl)amides useful as analgesics) | ⤷ Sign Up |
Japan | 2895145 | ⤷ Sign Up | |
Hong Kong | 78297 | N-phenyl-N-(4-piperidinyl)-amides useful as analgesics | ⤷ Sign Up |
Canada | 2010011 | N-PHENYL-N-(4-PIPERIDINYL) AMIDES UTILES COMME ANALGESIQUES (N-PHENYL-N-(4-PIPERIDINYL) AMIDES USEFUL AS ANALGESICS) | ⤷ Sign Up |
Slovakia | 402591 | N-PHENYL-N-(4-PIPERIDINYL)AMIDES, PHARMACEUTICAL COMPOSITIONSì (54) CONTAINING THEM AND THEIR USE | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ULTIVA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0383579 | C960030 | Netherlands | ⤷ Sign Up | 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 | SZ 34/1996 | Austria | ⤷ Sign Up | PRODUCT NAME: REMIFENTANIL UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SAEUREADDITIONSSALZE, EINSCHLIESSLICH REMIFENTANIL-HYDROCHLORID |
0383579 | 19675028 | Germany | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 |