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. Seven 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:	1
Raw Ingredient (Bulk) Api Vendors:	30
Patent Applications:	3,910
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

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	020747-006	Nov 4, 1998	4,863,737
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-003	Nov 4, 1998	4,671,953
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-005	Nov 4, 1998	5,785,989
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-004	Nov 4, 1998	5,785,989
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-001	Nov 4, 1998	4,671,953
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-003	Nov 4, 1998	4,863,737
Cephalon	ACTIQ	fentanyl citrate	TROCHE/LOZENGE;TRANSMUCOSAL	020747-006	Nov 4, 1998	5,785,989

International Patents for ACTIQ

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

Country	Patent Number	Title	Estimated Expiration
Canada	1271421	METHODES ET PRODUITS POUR L'ADMINISTRATION NON TRAUMATISANTE DE SEDATIFS, D'ANALGESIQUES ET D'ANESTHESIQUES (METHODS AND COMPOSITIONS FOR NONINVASIVE ADMINISTRATION OF SEDATIVES, ANALGESICS, AND ANESTHETICS)
Norway	920858
Spain	2133448
European Patent Office	0490916	COMPOSITION ET METHODES DE FABRICATION DE MEDICAMENTS A DISSOLUTION ORALE. (COMPOSITIONS AND METHODS OF MANUFACTURE OF ORAL DISSOLVABLE MEDICAMENTS.)
Denmark	0490944
World Intellectual Property Organization (WIPO)	9103099
Australia	645265

Supplementary Protection Certificates for ACTIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0836511	CA 2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID
1635783	300653	Netherlands		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		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
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
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
1635783	122014000024	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0901368	C300523	Netherlands		PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ACTIQ

Last updated: July 28, 2025

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Introduction

ACTIQ, a branded fentanyl citrate lozenge, has long served as a potent analgesic for severe, breakthrough pain primarily in terminal cancer patients. Launched by Cerentino Pharmaceutical, ACTIQ's journey reflects complex market dynamics driven by regulatory landscapes, evolving medical needs, and challenges associated with opioid management. This article analyzes the current market environment, financial trajectory, and strategic considerations influencing ACTIQ's positioning within the pharmaceutical sector.

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Overview of ACTIQ

ACTIQ (fentanyl citrate lozenge) was approved by the U.S. Food and Drug Administration (FDA) in the late 1990s. Its unique delivery system—a lozenge designed to be dissolved in the mouth—offered rapid pain relief, making it a preferred choice among clinicians managing breakthrough cancer pain. As a Schedule II controlled substance, ACTIQ's formulation leverages fentanyl's high potency, necessitating strict oversight and responsible prescribing practices.

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Market Dynamics

1. Evolving Opioid Regulations

Regulatory climate significantly influences ACTIQ’s market landscape. The opioid epidemic, particularly in North America, has led to heightened scrutiny and tighter prescribing guidelines. Agencies such as the CDC have implemented measures that restrict heavy opioid use, impacting sales volumes for drugs like ACTIQ. According to CDC guidelines (2016), healthcare providers are encouraged to adopt multimodal pain management to reduce reliance on high-potency opioids, directly affecting companies marketing drugs like ACTIQ.

2. Competitive Landscape

The analgesic market is highly competitive, with various formulations vying for market share. Non-opioid alternatives, including NSAIDs, acetaminophen formulations, and adjuvant therapies, increasingly replace opioids for some pain management scenarios. Additionally, abuse-deterrent formulations (ADFs) like OxyContin with tamper-resistant features have gained prominence, challenging traditional fentanyl products.

Meanwhile, newer transdermal fentanyl patches and nasal sprays have emerged, offering similar efficacy with differing administration routes. The competitive pressure compels manufacturers to innovate or diversify their portfolios.

3. Patent and Intellectual Property Status

ACTIQ's original patent protection has expired or is nearing expiry, opening avenues for generic formulations. As generic fentanyl lozenges and other equivalents become available, price competition intensifies, compressing profit margins. Patent expiration typically triggers significant revenue declines unless the original manufacturer maintains brand loyalty or develops subsequent innovations.

4. Medical Advancements and Treatment Guidelines

Emerging data advocating for caution in opioid use underpins cautious prescribing of ACTIQ. Concurrently, alternative therapies—including nerve blocks and non-pharmacologic interventions—are increasingly integrated into pain management protocols, reducing dependence on opioid-based drugs. Medical institutions' guidelines, such as ASCO’s (American Society of Clinical Oncology), influence the prescribing patterns that directly affect ACTIQ's market share.

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Financial Trajectory

1. Revenue Trends

Historically, ACTIQ experienced declining sales aligned with broader opioid regulations and market saturation. According to IQVIA data, sales peaked during the early 2000s before witnessing a gradual decline, with 2010s showing sharp drops due to increased regulatory oversight and the advent of alternative therapies.

Post-2017, with intensifying opioid restrictions, revenue data indicate a further contraction, moving from hundreds of millions of dollars annually to a few dozen million dollars in recent years. These declines reflect a combination of patent expiry, increased competition, and shifting clinical practices.

2. Impact of Patent Expiration and Generics

The expiration of key patents in the late 2010s precipitated a wave of generic fentanyl lozenges. Generic manufacturers, such as Teva and Mylan, launched competitive equivalents priced significantly lower, reducing ACTIQ’s market share and profitability. The market's price erosion reflects the classic generic competition dynamic.

3. Opportunities for Lifecycle Extension

In response, Cerentino Pharmaceutical has pursued lifecycle management strategies, including formulations with abuse-deterrent features and regional expansions. These initiatives aim to preserve revenue streams amid generic onslaughts. However, the effectiveness of such strategies remains constrained by regulatory hurdles and market acceptance.

4. Future Revenue Projections

Projections suggest continued decline in sales unless new indications, formulations, or formulations with improved safety profiles are approved. The increasing preference for non-opioid analgesics and stricter prescribing protocols pose persistent barriers. Nonetheless, niche markets, such as end-of-life care where pain management remains paramount, could sustain modest revenue streams.

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Market Trends Influencing Financial Trajectory

• Regulatory Stringency: Increasing governmental oversight and risk mitigation efforts suppress sales growth.

• Clinical Practice Shift: Growing emphasis on multimodal and non-opioid pain management displaces reliance on drugs like ACTIQ.

• Generic Competition: Price erosion dominates post-patent expiry, pulling down potential revenues.

• Patient Safety Initiatives: Abuse-deterrent formulations are gaining favor, presenting opportunities for lifecycle extension but also incurring higher development costs.

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Strategic Outlook

Given the current environment, the financial outlook indicates a downward trajectory for ACTIQ. The focus for manufacturers may shift towards:

• Developing abuse-deterrent formulations.
• Expanding into regions with less regulatory restriction.
• Diversifying analgesic portfolios to include non-opioid options.

Alternatively, companies might prioritize acquisition or licensing deals for innovative formulations aimed at safer, more controlled pain management.

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Key Considerations for Stakeholders

• Payers and Providers: Growing emphasis on reducing opioid prescriptions necessitates advocacy for alternative therapies.
• Investors: Potential valuation declines are anticipated unless companies effectively innovate or pivot.
• Regulatory Bodies: Continued push for abuse-deterrent systems and monitoring of opioid misuse impacts market supply.

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Conclusion

The market dynamics surrounding ACTIQ hinge on regulatory, competitive, and clinical practice shifts. Its financial trajectory is marked by declining revenues steered by patent expiries and regulatory constraints. While opportunities exist through formulation innovations and regional expansion, the overall outlook suggests a shrinking market unless significant lifecycle management strategies are employed.

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Key Takeaways

• Regulatory pressure remains the primary driver suppressing ACTIQ’s sales, emphasizing the importance of compliance and innovation.
• Patent expiries have accelerated generic competition, compressing profit margins.
• Evolving pain management protocols favor non-opioid options and multimodal therapies, reducing reliance on drugs like ACTIQ.
• Lifecycle management initiatives such as abuse-deterrent formulations are essential to sustain revenue streams.
• Strategic diversification into alternative formulations and regions can mitigate declining trends.

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FAQs

1. How does patent expiration impact ACTIQ’s market?
Patent expiry allows generic manufacturers to produce equivalent fentanyl lozenges, leading to increased competition and significant pricing pressure, which reduces revenue for the original patent-holder.

2. What are the main regulatory challenges facing ACTIQ?
Stringent control measures aimed at curbing opioid misuse limit prescribing, enforce tighter dispensing regulations, and promote alternative pain management, all reducing the drug’s market potential.

3. Are there developments to improve the safety profile of ACTIQ?
Yes. Abuse-deterrent formulations and new delivery systems are being developed to mitigate misuse, aiming to extend the product’s lifecycle amid regulatory scrutiny.

4. Can ACTIQ regain market share in the future?
Potentially, through innovations such as abuse-deterrent formulations and targeted regional marketing. However, competition from non-opioid therapies and stricter regulations remain obstacles.

5. What alternative therapies could replace ACTIQ?
Non-opioid analgesics, nerve blocks, and other advanced pain management techniques are increasingly favored, especially in response to the opioid crisis.

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References

[1] CDC Guidelines for Prescribing Opioids for Chronic Pain, 2016.

[2] IQVIA Sales Data, 2022.

[3] FDA Approvals and Labeling Information, 1999 onward.

[4] American Society of Clinical Oncology (ASCO) Pain Management Guidelines, 2020.

[5] Market Analysis Reports on Opioid and Analgesic Drugs, 2022.