ACTIQ Drug Patent Profile

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 11^th, 1984.

Summary for ACTIQ

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	39
Patent Applications:	4,087
Drug Prices:	Drug price information for ACTIQ
What excipients (inactive ingredients) are in ACTIQ?	ACTIQ excipients list
DailyMed Link:	ACTIQ at DailyMed

See drug prices for ACTIQ

Pharmacology for ACTIQ

Drug Class	Opioid Agonist
Mechanism of Action	Full 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		DISCN	Yes	No
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-004	Nov 4, 1998		DISCN	Yes	No
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-002	Nov 4, 1998		DISCN	Yes	No
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-003	Nov 4, 1998		DISCN	Yes	No
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-006	Nov 4, 1998		DISCN	Yes	No
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-005	Nov 4, 1998		DISCN	Yes	No

Expired US Patents for ACTIQ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-004	Nov 4, 1998
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-006	Nov 4, 1998
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-005	Nov 4, 1998
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-002	Nov 4, 1998
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-003	Nov 4, 1998
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-001	Nov 4, 1998

International Patents for ACTIQ

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

Country	Patent Number	Title	Estimated Expiration
Australia	642664
Norway	319057
Japan	2749198
Norway	304056
European Patent Office	0490916	COMPOSITION ET METHODES DE FABRICATION DE MEDICAMENTS A DISSOLUTION ORALE. (COMPOSITIONS AND METHODS OF MANUFACTURE OF ORAL DISSOLVABLE MEDICAMENTS.)
Norway	962808

Supplementary Protection Certificates for ACTIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1769785	C300522	Netherlands		PRODUCT NAME: FENTANYL EN DOSERINGSAPPLICATOR; REG. NO/DATE: EU/2/11/127/001 20111006
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
0836511	CA 2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID
1635783	CA 2014 00016	Denmark		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
0836511	122006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
0383579	C960030	Netherlands		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

ACTIQ Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for ACTIQ

Introduction

ACTIQ, a transmucosal fentanyl citrate lozenge, is a potent opioid agonist specifically designed for the management of breakthrough pain in cancer patients who are already receiving and tolerant to around-the-clock opioid therapy. Here, we delve into the market dynamics and financial trajectory of ACTIQ, including its indications, market entry, competition, and financial performance.

Indications and Usage

ACTIQ is indicated for the management of breakthrough pain in cancer patients 16 years of age and older who are already receiving and tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain. Patients must be on a stable dose of an opioid medication to be eligible for ACTIQ[1][3].

Market Entry and Patent Landscape

ACTIQ was initially marketed by Cephalon, Inc. Following a patent dispute, Barr Pharmaceuticals, Inc. launched a generic version of ACTIQ in September 2006, after reaching a settlement with Cephalon. This settlement allowed Barr to commercialize its generic product earlier than anticipated, providing a more affordable option for patients[2].

Financial Performance

At the time of the generic launch, ACTIQ had significant annual sales, approximately $590 million, based on IMS sales data for the twelve months ended July 2006. The introduction of a generic version by Barr Pharmaceuticals was expected to impact the market share and revenue of the branded product, but it also expanded access to this critical pain management therapy for more patients[2].

Competition in the Fentanyl Market

The fentanyl market is highly competitive, with several other products available for breakthrough cancer pain, including Fentora (fentanyl buccal tablet), Abstral (sublingual tablets), Lazanda (fentanyl citrate nasal spray), Onsolis (fentanyl buccal film), and Subsys (fentanyl sublingual spray). These products, like ACTIQ, are subject to strict prescribing and dispensing guidelines due to their high potency and potential for abuse[3].

Regulatory Environment

ACTIQ and its generic versions are subject to the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program, which is designed to mitigate the risks of respiratory depression, overdose, and other adverse effects associated with these potent opioids. This program requires patients to be enrolled and prescribers to be certified, adding a layer of complexity to the market dynamics[1][3].

Abuse Potential and Safety Concerns

The high abuse potential and safety concerns surrounding ACTIQ and other fentanyl products have significant implications for their market trajectory. Fatal respiratory depression has occurred in patients treated with ACTIQ, especially in those who are not opioid-tolerant or who receive improper dosing. These risks necessitate strict prescribing guidelines and monitoring, which can affect market penetration and patient access[1].

Impact of Generic Competition

The introduction of generic ACTIQ by Barr Pharmaceuticals marked a significant shift in the market. Generic competition typically leads to lower prices and increased accessibility for patients. However, the unique nature of TIRF products, including the need for REMS enrollment and strict prescribing guidelines, can mitigate some of the typical effects of generic competition on market prices and patient access[2].

Financial Projections and Market Trends

The financial performance of ACTIQ and its generic versions is influenced by several factors, including market demand, competition from other fentanyl products, and regulatory changes. Despite the competition, the demand for effective breakthrough pain management in cancer patients remains high, ensuring a stable market for these products. However, the financial projections must consider the complexities of the opioid market, including reimbursement policies, regulatory scrutiny, and the ongoing opioid crisis[2].

Ethical and Legal Considerations

The market dynamics of ACTIQ have also been influenced by ethical and legal issues. For example, Insys Therapeutics faced legal action for its aggressive marketing practices and misrepresentation of patient diagnoses to secure insurance coverage for its fentanyl product, Subsys. Such incidents highlight the need for ethical marketing and prescribing practices in the opioid market[5].

Conclusion

The market dynamics and financial trajectory of ACTIQ are complex, influenced by its specific indications, the competitive landscape of fentanyl products, regulatory requirements, and ethical considerations. Here are the key points:

• Indications and Usage: ACTIQ is for breakthrough pain in opioid-tolerant cancer patients.
• Market Entry: Initially marketed by Cephalon, with a generic version launched by Barr Pharmaceuticals in 2006.
• Financial Performance: Significant annual sales, impacted by generic competition.
• Competition: Part of a competitive fentanyl market with strict regulatory guidelines.
• Regulatory Environment: Subject to TIRF REMS Access program.
• Abuse Potential: High risk of respiratory depression and overdose.
• Generic Competition: Lower prices and increased accessibility but with unique regulatory constraints.
• Financial Projections: Influenced by market demand, competition, and regulatory changes.
• Ethical and Legal Considerations: Ethical marketing and prescribing practices are crucial.

Key Takeaways

• ACTIQ is a critical pain management therapy for breakthrough cancer pain in opioid-tolerant patients.
• The market is highly competitive with several fentanyl products available.
• Regulatory requirements, such as the TIRF REMS Access program, are stringent.
• Generic competition has increased accessibility but with unique constraints.
• Ethical marketing and prescribing practices are essential.

FAQs

Q: What is ACTIQ used for? A: ACTIQ is used for the management of breakthrough pain in cancer patients who are already receiving and tolerant to around-the-clock opioid therapy.

Q: Who can prescribe ACTIQ? A: Only certified prescribers who are part of the TIRF REMS Access program can prescribe ACTIQ.

Q: What are the risks associated with ACTIQ? A: ACTIQ carries a high risk of respiratory depression, overdose, and other adverse effects, especially in non-opioid tolerant patients.

Q: How does the generic version of ACTIQ affect the market? A: The generic version increases accessibility and reduces costs but operates within the same regulatory constraints as the branded product.

Q: What regulatory program does ACTIQ fall under? A: ACTIQ falls under the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access program.

Sources

1. Actiq (fentanyl citrate) oral transmucosal lozenge - accessdata.fda.gov
2. Barr Pharmaceuticals, Inc. Launches Generic ACTIQ(R) Cancer Pain Management Product - Biospace
3. Actiq-Abstral-Fentora-Lazanda-Onsolis-Subsys - Minnesota.gov
4. Fentanyl availability on darknet markets - Australian Institute of Criminology
5. Insys-Complaint.pdf - NJ.gov