REMIFENTANIL HYDROCHLORIDE Drug Patent Profile
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Which patents cover Remifentanil Hydrochloride, and when can generic versions of Remifentanil Hydrochloride launch?
Remifentanil Hydrochloride is a drug marketed by Fresenius Kabi Usa and Hikma and is included in two NDAs.
The generic ingredient in REMIFENTANIL HYDROCHLORIDE 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 Remifentanil Hydrochloride
A generic version of REMIFENTANIL HYDROCHLORIDE was approved as remifentanil hydrochloride by FRESENIUS KABI USA on January 16th, 2018.
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Questions you can ask:
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Summary for REMIFENTANIL HYDROCHLORIDE
US Patents: | 0 |
Applicants: | 2 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 27 |
Clinical Trials: | 722 |
Patent Applications: | 324 |
Formulation / Manufacturing: | see details |
DailyMed Link: | REMIFENTANIL HYDROCHLORIDE at DailyMed |
![REMIFENTANIL HYDROCHLORIDE drug patent expirations Drug patent expirations by year for REMIFENTANIL HYDROCHLORIDE](/p/graph/s/t/REMIFENTANIL_HYDROCHLORIDE-patent-expirations.png)
Recent Clinical Trials for REMIFENTANIL HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | N/A |
Cedars-Sinai Medical Center | Phase 2 |
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital | N/A |
Pharmacology for REMIFENTANIL HYDROCHLORIDE
Drug Class | Opioid Agonist |
Mechanism of Action | Full Opioid Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for REMIFENTANIL HYDROCHLORIDE
Paragraph IV (Patent) Challenges for REMIFENTANIL HYDROCHLORIDE
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 REMIFENTANIL HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fresenius Kabi Usa | REMIFENTANIL HYDROCHLORIDE | remifentanil hydrochloride | INJECTABLE;INJECTION | 206223-001 | Jan 16, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hikma | REMIFENTANIL HYDROCHLORIDE | remifentanil hydrochloride | INJECTABLE;INJECTION | 210594-001 | Oct 13, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Fresenius Kabi Usa | REMIFENTANIL HYDROCHLORIDE | remifentanil hydrochloride | INJECTABLE;INJECTION | 206223-002 | Jan 16, 2018 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Fresenius Kabi Usa | REMIFENTANIL HYDROCHLORIDE | remifentanil hydrochloride | INJECTABLE;INJECTION | 206223-003 | Jan 16, 2018 | AP | RX | No | 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 |