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. Four 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: | 35 |
Clinical Trials: | 98 |
Patent Applications: | 5,119 |
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-002 | Jul 12, 1996 | AP | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-003 | Jul 12, 1996 | AP | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
>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 | 020630-003 | Jul 12, 1996 | See Plans and Pricing | See Plans and Pricing |
Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-001 | Jul 12, 1996 | See Plans and Pricing | See Plans and Pricing |
Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-003 | Jul 12, 1996 | See Plans and Pricing | See Plans and Pricing |
>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 |
---|---|---|---|
Hong Kong | 78297 | N-phenyl-N-(4-piperidinyl)-amides useful as analgesics | See Plans and Pricing |
Spain | 2088961 | See Plans and Pricing | |
New Zealand | 232542 | N-PHENYL-N-(4-PIPERIDINYL)AMIDE DERIVATIVES; PREPARATORY PROCESSES AND PHARMACEUTICAL COMPOSITIONS | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ULTIVA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0383579 | 19675028 | Germany | See Plans and Pricing | 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 | See Plans and Pricing | 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 | See Plans and Pricing | 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 |