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. Six 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

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

International Patents for ACTIQ

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

Country	Patent Number	Title	Estimated Expiration
Japan	H05500041
World Intellectual Property Organization (WIPO)	9103234
Japan	H05503917
Germany	69027216
Spain	2133448
Japan	H05500176
Spain	2247598

Supplementary Protection Certificates for ACTIQ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1635783	300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0836511	122006000022	Germany		PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
0975367	122011000009	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
1635783	122014000024	Germany		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		PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
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
0836511	CA 2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID

Summary

Last updated: February 3, 2026

ACTIQ (fentanyl citrate) is a potent opioid analgesic indicated primarily for breakthrough pain in cancer patients. Its market dynamics depend on cancer prevalence, opioid prescribing regulations, and competition from alternative pain management therapies. The global opioid crisis influences regulatory and reimbursement landscapes, affecting commercial prospects. This analysis evaluates current market fundamentals, regulatory environment, competitive positioning, and growth drivers.

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What Are ACTIQ’s Market Position and Sales Drivers?

ACTIQ's revenue depends on cancer incidence, prescribing habits, and reimbursement policies. It faces competition from other transmucosal fentanyl formulations like Subsys (another fentanyl product), as well as non-opioid analgesics. In 2022, ACTIQ’s global sales were approximately $150 million, representing a decline due to patent expiries, regulatory restrictions, and generic alternatives.

Market Dynamics:

• Cancer Prevalence: Approximately 19.3 million new cancer cases were diagnosed globally in 2020, growing at 2-3% annually (WHO). The subset of patients experiencing breakthrough pain accounts for a significant part of analgesic sales.

• Physician Adoption: Physician prescribing trends favor newer formulations with improved delivery systems or safety profiles. ACTIQ has faced resistance due to its potent opioid nature and safety concerns.

• Reimbursement & Regulations: Stringent controls on opioid prescriptions in the US and Europe limit prescribing flexibility. Reimbursement coverage varies by country, impacting demand.

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What Are the Key Regulatory and Patent Considerations?

• Regulatory Status: Approved by the FDA for breakthrough pain in cancer patients. European approvals are comparable but may differ in labeling and restrictions.

• Patent Life and Patent Challenges: The original patent expired in 2015. Patent litigation and formulation exclusivities have allowed generic manufacturers to enter the market.

• Recent Regulatory Trends: Efforts to curb opioid misuse have increased scrutiny on formulations like ACTIQ. New formulations with abuse-deterrent properties are gaining favor.

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What Is the Competitive Landscape?

• Main Competitors:

  • Subsys (fentanyl sublingual spray) — Approved for similar indications, with a more discreet delivery system.
  • Fentora (fentanyl buccal tablets) — Alternative buccal fentanyl product.
  • Generic fentanyl products — Significantly eroding sales post-patent expiry.

• Differentiators:

  • Delivery method (lollipop vs. spray or tablet)
  • Abuse-deterrent technology
  • Prescriber familiarity and patient comfort

The competitive advantage of ACTIQ diminishes as generics and newer formulations gain market share.

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How Do Broader Market and Policy Trends Affect ACTIQ?

• Opioid Prescribing Trends: Heightened restrictions and opioid stewardship programs decrease overall opioid utilization, particularly for outpatient pain management.

• Opioid Crisis Impact: The US opioid epidemic led to increased regulatory oversight, impacting sales and marketing.

• Growth Opportunities:

  • Specific niches such as palliative care for cancer patients remain relevant.
  • Innovations in delivery and safety profiles could provide a competitive edge.

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What Is the Financial Outlook?

• Sales Trends: Declining in mature markets due to patent loss and generic competition; potential growth in select markets with high cancer prevalence.

• Cost of Goods and Margins: Margins likely compressed due to increased competition and regulatory compliance costs.

• Investment Considerations:

  • Limited near-term upside without new formulations.
  • Long-term viability hinges on product differentiation and regulatory acceptance.

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What Are the Risks and Challenges?

• Regulatory restrictions aimed at curbing opioid abuse may limit sales growth.
• dwindling market share below branded products with abuse-deterrent features.
• Potential for litigation related to opioid safety and marketing practices.
• Post-patent explosion leading to erosion of revenues.

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Key Takeaways

• ACTIQ faces a challenging market landscape due to patent expiry, regulatory restrictions, and competition.
• Growth prospects depend on niche demand in palliative care settings and potential reformulations with abuse-deterrent properties.
• Market share erosion accelerated by the opioid crisis and the advent of generic products.
• Regulatory and public health trends favor lower-dose or abuse-deterrent formulations, influencing future demand.
• Financial viability requires innovation and strategic positioning in a constrained environment.

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FAQs

1. What is the primary FDA-approved use of ACTIQ?
   Breakthrough pain management in adult cancer patients already receiving opioid therapy.

2. How has patent expiry impacted ACTIQ?
   It opened the market to generic fentanyl products, significantly decreasing branded sales.

3. Are there new formulations of ACTIQ?
   As of 2023, no new formulations have been approved; focus has shifted to abuse-deterrent alternatives.

4. What factors could help ACTIQ regain market share?
   Introducing abuse-deterrent formulations or expanding indication scope in palliative care.

5. What external factors threaten ACTIQ's future?
   Regulatory restrictions on opioids, consumer concerns about addiction, and competition from non-opioid therapies.

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Citations

[1] World Health Organization. Cancer Fact Sheet (2020).
[2] U.S. Food and Drug Administration. NDA Approvals and Labeling Data.
[3] MarketWatch. "Opioid Market Analysis," 2022.
[4] IMS Health. "Opioid Prescription Trends," 2022.