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Serving leading biopharmaceutical companies globally:

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Generated: December 15, 2017

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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Fentanyl hydrochloride has one hundred and eighty-six patent family members in thirty-four countries and ten supplementary protection certificates in four countries.

There are thirty-one drug master file entries for fentanyl hydrochloride. One supplier is listed for this compound.

Pharmacology for fentanyl hydrochloride

Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fentanyl hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
The Medicines CoIONSYSfentanyl hydrochlorideSYSTEM;IONTOPHORESIS, TRANSDERMAL021338-001May 22, 2006► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
9,645,179Self-test for analgesic product► Subscribe
6,317,629 Iontophoretic drug delivery apparatus► Subscribe
6,090,095 Electrotransport delivery device► Subscribe
6,505,069 Electrochemically reactive cathodes for an electrotransport device► Subscribe
7,054,683Methods of electrotransport drug delivery► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: fentanyl hydrochloride

Country Document Number Estimated Expiration
Mexico347308► Subscribe
World Intellectual Property Organization (WIPO)0025858► Subscribe
New Zealand511464► Subscribe
United Kingdom9725542► Subscribe
United Kingdom2317115► Subscribe
Finland972414► Subscribe
Japan4321966► Subscribe
Japan2016000351► Subscribe
Russian Federation2564084► Subscribe
JapanH10510179► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: FENTANYL HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006000022Germany► SubscribePRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
C/GB06/022United Kingdom► SubscribePRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
2014000024Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
2011000009Germany► SubscribePRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
00522Netherlands► SubscribePRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
00653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
2014 00016Denmark► SubscribePRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
0653Netherlands► SubscribePRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
00523Netherlands► SubscribePRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
00521Netherlands► SubscribePRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
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Serving leading biopharmaceutical companies globally:

UBS
Accenture
Healthtrust
Fuji
Farmers Insurance
US Department of Justice
Queensland Health
Mallinckrodt
Federal Trade Commission
Cerilliant

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.

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