Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

McKesson
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Last Updated: December 15, 2019

DrugPatentWatch Database Preview

ACTIQ Drug Profile

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Which patents cover Actiq, and what generic alternatives are available?

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. Twelve suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

US ANDA Litigation and Generic Entry Outlook for Actiq

A generic version of ACTIQ was launched as fentanyl citrate by HOSPIRA on December 15th, 2019.

Drug patent expirations by year for ACTIQ
Drug Prices for ACTIQ

See drug prices for ACTIQ

Recent Litigation for ACTIQ

Identify potential future generic entrants

District Court Litigation
Case NameDate
Purdue Pharmaceutical v. Actavis Elizabeth LLC2015-05-13
Cephalon Inc. v. Watson Pharmaceuticals Inc.2009-09-25
Cephalon Inc. v. Barr Pharmaceuticals Inc.2008-07-22

See all ACTIQ litigation

Pharmacology for ACTIQ
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Paragraph IV (Patent) Challenges for ACTIQ
Tradename Dosage Ingredient NDA Submissiondate
ACTIQ TROCHE/LOZENGE;TRANSMUCOSAL fentanyl citrate 020747 2004-12-20
ACTIQ TROCHE/LOZENGE;TRANSMUCOSAL fentanyl citrate 020747 2004-11-22
ACTIQ TROCHE/LOZENGE;TRANSMUCOSAL fentanyl citrate 020747 2004-10-29
ACTIQ TROCHE/LOZENGE;TRANSMUCOSAL fentanyl citrate 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 AB RX Yes No   Start Trial   Start Trial   Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-004 Nov 4, 1998 AB RX Yes No   Start Trial   Start Trial   Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-002 Nov 4, 1998 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-003 Nov 4, 1998 AB RX Yes No   Start Trial   Start Trial   Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-006 Nov 4, 1998 AB RX Yes No   Start Trial   Start Trial   Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-005 Nov 4, 1998 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

Expired US Patents for ACTIQ

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-006 Nov 4, 1998   Start Trial   Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-003 Nov 4, 1998   Start Trial   Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-005 Nov 4, 1998   Start Trial   Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-004 Nov 4, 1998   Start Trial   Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-001 Nov 4, 1998   Start Trial   Start Trial
Cephalon ACTIQ fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 020747-003 Nov 4, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Dow
Express Scripts
McKinsey
Mallinckrodt
Boehringer Ingelheim
McKesson

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