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Last Updated: November 2, 2024

DURAGESIC-25 Drug Patent Profile


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When do Duragesic-25 patents expire, and when can generic versions of Duragesic-25 launch?

Duragesic-25 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in DURAGESIC-25 is fentanyl. There are thirty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fentanyl profile page.

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Summary for DURAGESIC-25
Drug patent expirations by year for DURAGESIC-25
Recent Clinical Trials for DURAGESIC-25

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

SponsorPhase
Jiarong Chen, MDPhase 4
Emory UniversityPhase 4
Loyola UniversityPhase 2/Phase 3

See all DURAGESIC-25 clinical trials

US Patents and Regulatory Information for DURAGESIC-25

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms DURAGESIC-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-004 Aug 7, 1990 DISCN Yes 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 DURAGESIC-25

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms DURAGESIC-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-004 Aug 7, 1990 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms DURAGESIC-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-004 Aug 7, 1990 ⤷  Sign Up ⤷  Sign Up
Janssen Pharms DURAGESIC-25 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-004 Aug 7, 1990 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for DURAGESIC-25

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Kyowa Kirin Holdings B.V. PecFent fentanyl EMEA/H/C/001164
PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.
Authorised no no no 2010-08-31
Takeda Pharma A/S Instanyl fentanyl EMEA/H/C/000959
Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Authorised no no no 2009-07-20
Teva B.V. Effentora fentanyl EMEA/H/C/000833
Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain., , BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain., , Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. ,
Authorised no no no 2008-04-04
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for DURAGESIC-25

See the table below for patents covering DURAGESIC-25 around the world.

Country Patent Number Title Estimated Expiration
Spain 557179 ⤷  Sign Up
Spain 8802276 ⤷  Sign Up
Italy 1183912 SOMMINISTRAZIONE TRANSDERMICA DI FENTANILE E DISPOSITIVO PER TALE SOMMINISTRAZIONE ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DURAGESIC-25

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0836511 122006000022 Germany ⤷  Sign Up PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
1635783 122014000024 Germany ⤷  Sign Up PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0975367 122011000009 Germany ⤷  Sign Up 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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