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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Medtronic
Chubb
AstraZeneca
Merck
Colorcon
Cantor Fitzgerald
Cipla
Boehringer Ingelheim

Generated: July 22, 2018

DrugPatentWatch Database Preview

Fentanyl hydrochloride - Generic Drug Details

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

Fentanyl hydrochloride
is the generic ingredient in one branded drug marketed by The Medicines Co and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fentanyl hydrochloride has one hundred and seventy-five patent family members in thirty-three countries.

There are thirty-one drug master file entries for fentanyl hydrochloride. One supplier is listed for this compound.
Summary for fentanyl hydrochloride
Pharmacology for fentanyl hydrochloride
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Synonyms for fentanyl hydrochloride
1443-54-5
59H156XY46
AC1L36GM
AC1Q3E0D
Acetamide, N-phenyl-N-(1-(2-phenylethyl)-4-piperidinyl)-, monohydrochloride
CHEMBL1201159
D10811
DTXSID90162666
Fentanyl HCl
Fentanyl hydrochloride (JAN)
Fentanyl monohydrochloride
FT-0701144
Ionsys (TN)
LS-124440
MCV 4848
MLS002320669
N- propionanilidehydrochloride
n-(1-phenethyl-4-piperidyl)-n-phenyl-propanamide hydrochloride
N-(1-Phenethyl-4-piperidyl)propionanilide hydrochloride
N-(1-phenethylpiperidin-4-yl)-N-phenylpropanamide hydrochloride
NIH 10485
Propionanilide, N-(1-phenethyl-4-piperidyl)-, hydrochloride
SCHEMBL242876
SMR001338815
UNII-59H156XY46

US Patents and Regulatory Information for fentanyl hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 fentanyl hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
The Medicines Co IONSYS fentanyl hydrochloride SYSTEM;IONTOPHORESIS, TRANSDERMAL 021338-001 May 22, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for fentanyl hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,505,069 Electrochemically reactive cathodes for an electrotransport device ➤ Try a Free Trial
9,645,179 Self-test for analgesic product ➤ Try a Free Trial
6,317,629 Iontophoretic drug delivery apparatus ➤ Try a Free Trial
7,054,683 Methods of electrotransport drug delivery ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for fentanyl hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2011000009 Germany ➤ Try a Free Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
00523 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
C/GB06/022 United Kingdom ➤ Try a Free Trial PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
0653 Netherlands ➤ Try a Free Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Chubb
Covington
Argus Health
Colorcon
Mallinckrodt
US Department of Justice
Johnson and Johnson
Boehringer Ingelheim

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 verifification 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.