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Last Updated: August 5, 2020

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FENTANYL - Generic Drug Details

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

Fentanyl is the generic ingredient in twenty-five branded drugs marketed by Janssen Pharms, 3m Drug Delivery, Actavis Labs Ut Inc, Aveva, Lavipharm Labs, Mayne Pharma, Mylan Technologies, Noven, Specgx Llc, Btcp Pharma, Bdsi, Abbott, Hospira, Watson Labs, Dr Reddys, Fresenius Kabi Usa, Hikma, Akorn, Cephalon, Sentynl Theraps Inc, Actavis Labs Fl Inc, Par Pharm, and The Medicines Co, and is included in thirty NDAs. There are thirty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Fentanyl has thirty-one patent family members in seventeen countries.

There are thirty-one drug master file entries for fentanyl. Ten suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for FENTANYL

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Drug Sales Revenue Trends for FENTANYL

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Recent Clinical Trials for FENTANYL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Helse FonnaPhase 4
Udayana UniversityN/A
University of AarhusN/A

See all FENTANYL clinical trials

Generic filers with tentative approvals for FENTANYL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial800MCGTABLET;BUCCAL
  Start Trial  Start Trial600MCGTABLET;BUCCAL
  Start Trial  Start Trial400MCGTABLET;BUCCAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for FENTANYL
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Medical Subject Heading (MeSH) Categories for FENTANYL
Paragraph IV (Patent) Challenges for FENTANYL
Tradename Dosage Ingredient NDA Submissiondate
SUBSYS SPRAY;SUBLINGUAL fentanyl 202788 2017-12-07
SUBSYS SPRAY;SUBLINGUAL fentanyl 202788 2017-05-22
DURAGESIC-12 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-75 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-25 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-37 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-100 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813
DURAGESIC-50 FILM, EXTENDED RELEASE;TRANSDERMAL fentanyl 019813

US Patents and Regulatory Information for FENTANYL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-001 Jan 4, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-004 Jan 4, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Mylan Technologies FENTANYL-12 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 076258-005 Jan 23, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Aveva FENTANYL-75 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 077449-003 Oct 20, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
3m Drug Delivery FENTANYL-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 202097-002 Nov 4, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Btcp Pharma SUBSYS fentanyl SPRAY;SUBLINGUAL 202788-001 Jan 4, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
>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 FENTANYL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms DURAGESIC-75 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-002 Aug 7, 1990   Start Trial   Start Trial
Janssen Pharms DURAGESIC-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-004 Aug 7, 1990   Start Trial   Start Trial
Janssen Pharms DURAGESIC-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-001 Aug 7, 1990   Start Trial   Start Trial
Janssen Pharms DURAGESIC-100 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-001 Aug 7, 1990   Start Trial   Start Trial
Janssen Pharms DURAGESIC-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-004 Aug 7, 1990   Start Trial   Start Trial
Janssen Pharms DURAGESIC-75 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-002 Aug 7, 1990   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for FENTANYL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0836511 SPC/GB06/022 United Kingdom   Start Trial PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1635783 C300653 Netherlands   Start Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0836511 CA 2006 00019 Denmark   Start Trial PRODUCT NAME: FENTANYL HYDROCHLORID
1635783 300653 Netherlands   Start Trial PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
1769785 C300521 Netherlands   Start Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0975367 122011000009 Germany   Start Trial PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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