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Last Updated: September 25, 2020

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DURAGESIC-12 Drug Profile

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Which patents cover Duragesic-12, and what generic alternatives are available?

Duragesic-12 is a drug marketed by Janssen Pharms and is included in one NDA.

The generic ingredient in DURAGESIC-12 is fentanyl. There are thirty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the fentanyl profile page.

Drug patent expirations by year for DURAGESIC-12
Recent Clinical Trials for DURAGESIC-12

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

SponsorPhase
Jiarong Chen, MDPhase 4
Emory UniversityPhase 4
University of Central FloridaEarly Phase 1

See all DURAGESIC-12 clinical trials

Pharmacology for DURAGESIC-12
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Paragraph IV (Patent) Challenges for DURAGESIC-12
Tradename Dosage Ingredient NDA Submissiondate
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 DURAGESIC-12

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-12 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 019813-005 Feb 4, 2005 AB RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for DURAGESIC-12

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0383579 C960030 Netherlands   Start Trial PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
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
0836511 CA 2006 00019 Denmark   Start Trial PRODUCT NAME: FENTANYL HYDROCHLORID
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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