Remifentanil hydrochloride - Generic Drug Details
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What are the generic drug sources for remifentanil hydrochloride and what is the scope of freedom to operate?
Remifentanil hydrochloride
is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Hikma, Nivagen Pharms Inc, and Mylan Institutional, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for remifentanil hydrochloride. Four suppliers are listed for this compound.
Summary for remifentanil hydrochloride
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 4 |
| NDAs: | 4 |
| Drug Master File Entries: | 3 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 27 |
| Clinical Trials: | 722 |
| Patent Applications: | 492 |
| What excipients (inactive ingredients) are in remifentanil hydrochloride? | remifentanil hydrochloride excipients list |
| DailyMed Link: | remifentanil hydrochloride at DailyMed |
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 |
| Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital | N/A |
| Cedars-Sinai Medical Center | Phase 2 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-001 | Jul 12, 1996 | AP | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Nivagen Pharms Inc | REMIFENTANIL HYDROCHLORIDE | remifentanil hydrochloride | INJECTABLE;INJECTION | 215635-003 | Jun 28, 2024 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Hikma | REMIFENTANIL HYDROCHLORIDE | remifentanil hydrochloride | INJECTABLE;INJECTION | 210594-003 | Oct 13, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Nivagen Pharms Inc | REMIFENTANIL HYDROCHLORIDE | remifentanil hydrochloride | INJECTABLE;INJECTION | 215635-002 | Jun 28, 2024 | 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 |
Expired US Patents for remifentanil hydrochloride
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-001 | Jul 12, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-002 | Jul 12, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-002 | Jul 12, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-003 | Jul 12, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-003 | Jul 12, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan Institutional | ULTIVA | remifentanil hydrochloride | INJECTABLE;INJECTION | 020630-003 | Jul 12, 1996 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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.
ISSN: 2162-2639
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