You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 2, 2024

ACTIQ Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Actiq patents expire, and when can generic versions of Actiq launch?

Actiq is a drug marketed by Cephalon and is included in one NDA.

The generic ingredient in ACTIQ is fentanyl citrate. 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 citrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Actiq

A generic version of ACTIQ was approved as fentanyl citrate by HIKMA on July 11th, 1984.

  Sign Up

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for ACTIQ?
  • What are the global sales for ACTIQ?
  • What is Average Wholesale Price for ACTIQ?
Summary for ACTIQ
Drug patent expirations by year for ACTIQ
Drug Prices for ACTIQ

See drug prices for ACTIQ

Pharmacology for ACTIQ
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Paragraph IV (Patent) Challenges for ACTIQ
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ACTIQ Lozenges fentanyl citrate 0.6 mg 020747 2004-12-20
ACTIQ Lozenges fentanyl citrate 0.8 mg, 1.2 mg and 1.6 mg 020747 2004-11-22
ACTIQ Lozenges fentanyl citrate 0.2 mg 020747 2004-10-29
ACTIQ Lozenges fentanyl citrate 0.4 mg 020747 2004-10-06

US Patents and Regulatory Information for ACTIQ

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-001 Nov 4, 1998 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-004 Nov 4, 1998 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-002 Nov 4, 1998 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-003 Nov 4, 1998 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-006 Nov 4, 1998 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-005 Nov 4, 1998 RX 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 ACTIQ

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-002 Nov 4, 1998 ⤷  Sign Up ⤷  Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-004 Nov 4, 1998 ⤷  Sign Up ⤷  Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-001 Nov 4, 1998 ⤷  Sign Up ⤷  Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-006 Nov 4, 1998 ⤷  Sign Up ⤷  Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-005 Nov 4, 1998 ⤷  Sign Up ⤷  Sign Up
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-004 Nov 4, 1998 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ACTIQ

See the table below for patents covering ACTIQ around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 0630647 Composition et méthodes de fabrication de médicaments à dissolution orale (Compositions and methods of manufacture of oral dissolvable medicaments) ⤷  Sign Up
Australia 641622 ⤷  Sign Up
Australia 643233 ⤷  Sign Up
Germany 3678195 ⤷  Sign Up
Canada 2066403 FORME PHARMACEUTIQUE PERMETTANT L'ABSORPTION A TRAVERS LA MUQUEUSE (TRANSMUCOSAL DOSAGE FORM) ⤷  Sign Up
Germany 69027216 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ACTIQ

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
0836511 SPC/GB06/022 United Kingdom ⤷  Sign Up PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1635783 C300653 Netherlands ⤷  Sign Up PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
1635783 CA 2014 00016 Denmark ⤷  Sign Up PRODUCT 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.