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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Fish and Richardson
Express Scripts
AstraZeneca
Argus Health
UBS
Boehringer Ingelheim
Colorcon
US Army

Generated: December 18, 2018

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Remifentanil hydrochloride - Generic Drug Details

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What are the generic sources for remifentanil hydrochloride and what is the scope of remifentanil hydrochloride freedom to operate?

Remifentanil hydrochloride is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa and Mylan Institutional, and is included in two NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for remifentanil hydrochloride. Two suppliers are listed for this compound.

Pharmacology for remifentanil hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Synonyms for remifentanil hydrochloride
1-Piperidinepropanoic acid, 4-(methoxycarbonyl)-4-((1-oxopropyl)phenylamino)-, methyl ester, monohydrochloride
132539-07-2
132875-61-7 (Parent)
3-[methoxycarbonyl-4-[(1-oxopropyl)phenylamino]1-piperidine]propanoic acid methyl ester hydrochloride
4-(Methoxycarbonyl)-4-[(1-oxopropyl)phenylamino]-1-piperidinepropanoic Acid Methyl Ester Hydrochloride
4-Carboxy-4-(N-phenylpropionamido)-1-piperidine propionic acid, dimethyl ester, monohydrochloride
5V444H5WIC
AC1L1TZ5
AC1Q3E9W
C20H28N2O5.HCl
CHEBI:32091
CHEMBL1201120
D01177
DTXSID50157614
FT-0674340
GI 87084B
GI-87084B
HE306791
LS-172838
methyl 1-(3-methoxy-3-oxopropyl)-4-(N-propanoylanilino)piperidine-4-carboxylate hydrochloride
methyl-1-(3-methoxy-3-oxopropyl)-4-[phenyl(propanoyl)amino]piperidin-4-carboxylathydrochlorid
Remifentanil HCl
Remifentanil hydrochloride (JAN/USAN)
Remifentanil hydrochloride [USAN]
Remifentanil hydrochloride solution, 100 mug/mL in methanol (as free base), certified reference material
Remifentanil hydrochloride, >=97% (HPLC), powder
Remifentanil hydrochloride, European Pharmacopoeia (EP) Reference Standard
remifentanil monohydrochloride
Remifentanyl Hydrochloride
SCHEMBL41242
Ultiva
UNII-5V444H5WIC

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 206223-003 Jan 16, 2018 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 020630-003 Jul 12, 1996 AP RX Yes Yes ➤ 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
Mylan Institutional ULTIVA remifentanil hydrochloride INJECTABLE;INJECTION 020630-002 Jul 12, 1996 AP RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Fresenius Kabi Usa REMIFENTANIL HYDROCHLORIDE remifentanil hydrochloride INJECTABLE;INJECTION 206223-001 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

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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 020630-002 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 020630-001 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 020630-002 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 020630-001 Jul 12, 1996 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
Fish and Richardson
Express Scripts
AstraZeneca
Argus Health
UBS
Boehringer Ingelheim
Colorcon
US Army

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