ABSTRAL Drug Patent Profile

When do Abstral patents expire, and what generic alternatives are available?

Abstral is a drug marketed by Sentynl Theraps Inc and is included in one NDA.

The generic ingredient in ABSTRAL 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 Abstral

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

Summary for ABSTRAL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	34
Clinical Trials:	7
Drug Prices:	Drug price information for ABSTRAL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABSTRAL
What excipients (inactive ingredients) are in ABSTRAL?	ABSTRAL excipients list
DailyMed Link:	ABSTRAL at DailyMed

See drug prices for ABSTRAL

Recent Clinical Trials for ABSTRAL

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
M.D. Anderson Cancer Center	Phase 3
National Cancer Institute (NCI)	Phase 3
Institute of Mountain Emergency Medicine	Phase 4

See all ABSTRAL clinical trials

Paragraph IV (Patent) Challenges for ABSTRAL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ABSTRAL	Sublingual Tablets	fentanyl citrate	0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg	022510	1	2014-06-19

US Patents and Regulatory Information for ABSTRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-001	Jan 7, 2011		DISCN	Yes	No
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-004	Jan 7, 2011		DISCN	Yes	No
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-002	Jan 7, 2011		DISCN	Yes	No
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-003	Jan 7, 2011		DISCN	Yes	No

Expired US Patents for ABSTRAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-006	Jan 7, 2011	6,761,910
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-003	Jan 7, 2011	6,759,059
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-005	Jan 7, 2011	7,910,132
Sentynl Theraps Inc	ABSTRAL	fentanyl citrate	TABLET;SUBLINGUAL	022510-004	Jan 7, 2011	7,910,132

International Patents for ABSTRAL

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

Country	Patent Number	Title	Estimated Expiration
Spain	2207295
Norway	332226
Sweden	9803240
European Patent Office	2805716	Composition pharmaceutique comprenant la buprénorphine ayant une action rapide (A pharmaceutical composition comprising buprenorphine having a rapid action)

Supplementary Protection Certificates for ABSTRAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2236132	300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
0836511	CA 2006 00019	Denmark		PRODUCT NAME: FENTANYL HYDROCHLORID
2236132	CA 2015 00004	Denmark		PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ABSTRAL

Last updated: July 27, 2025

Introduction

ABSTRAL (fentanyl citrate) is a potent synthetic opioid analgesic approved by the U.S. Food and Drug Administration (FDA) for managing breakthrough pain in adult patients suffering from cancer who are already receiving opioid therapy for persistent pain. Since its launch, ABSTRAL has carved a significant niche within the broader opioid therapy market. This analysis delves into the key market drivers, competitive landscape, regulatory environment, manufacturing considerations, and the financial trajectory influencing ABSTRAL's position in global healthcare.

Market Overview and Key Drivers

The global pain management market is experiencing vigorous growth, driven by factors such as increasing prevalence of chronic pain conditions, rising geriatric populations, and expanding cancer diagnoses worldwide [1]. Specifically, breakthrough pain in cancer patients necessitates rapid-onset opioid options, positioning ABSTRAL as a convenient sublingual formulation with rapid absorption, appealing to clinicians and patients alike.

The unmet need for fast-acting opioid analgesics with reliable bioavailability has bolstered ABSTRAL's market adoption. As cancer treatments improve and survival rates increase, demand for effective pain management options like ABSTRAL is expected to grow proportionally.

Furthermore, innovations in delivery mechanisms—such as sublingual tablets—improve patient compliance and reduce abuse potential relative to injectable opioids, aligning with healthcare providers' focus on safer pain management. The drug's positioning as a specialized medication for breakthrough pain rather than chronic or maintenance therapy further underscores its niche market role.

Competitive Landscape and Market Share

ABSTRAL faces competition from multiple formulations including oral opioids, transdermal patches, and nasal sprays like Fentora (fentanyl buccal), Subsys (fentanyl sublingual spray), and Actiq (fentanyl lozenge). While these products compete directly on rapidity and ease of administration, ABSTRAL's sublingual delivery offers a favorable balance of speed and convenience, aiming to capture patients who need quick relief without invasive methods.

In terms of market share, ABSTRAL holds a modest but steady position within the fast-acting opioid segment. The competitiveness is also driven by formulary inclusion, physician prescribing habits, and insurance reimbursement policies. Also, with the opioid crisis, stricter regulations and monitoring measures have affected prescribing behaviors, impacting sales trajectories.

Regulatory and Legal Environment

Opioid medications, including ABSTRAL, operate under intense regulatory scrutiny due to misuse and addiction concerns. Agencies such as the FDA have implemented mechanisms to monitor prescribing patterns, restrict access to high-potency opioids, and enforce prescribing guidelines. The Drug Enforcement Administration (DEA) classifies fentanyl formulations as Schedule II controlled substances, imposing stringent storage, prescribing, and distribution requirements.

These regulatory frameworks influence market dynamics, often leading to increased compliance costs for manufacturers and prescribers. The evolving legal landscape exerts downward pressure on sales volume growth but can also incentivize development of abuse-deterrent formulations, potentially opening new avenues for market expansion.

Manufacturing and Supply Chain Considerations

ABSTRAL's production requires specialized facilities complying with Good Manufacturing Practices (GMP). Consistent manufacturing quality ensures product efficacy and safety, crucial in maintaining regulatory approval and market confidence. Supply chain stability is essential, especially considering the illicit diversion of fentanyl analogs globally. Responsible manufacturing and distribution, coupled with vigilant monitoring, are critical for sustaining market integrity and avoiding regulatory penalties.

Financial Trajectory and Revenue Outlook

Since its launch, ABSTRAL’s financial performance has been shaped by market penetration, competitive dynamics, and regulatory influence. The initial phase demonstrated solid adoption, especially in specialized oncology centers. However, growth has been moderated by the opioid crisis, which prompted tighter controls and reduced prescribing.

Future revenue streams hinge on several factors:

• Market Penetration: Expanding into new regions with rising cancer burdens such as Asia Pacific and Latin America.
• Pipeline Innovations: Development of abuse-deterrent formulations or alternative delivery mechanisms. Recent FDA approvals for abuse-deterrent versions of fentanyl products suggest that companies investing in safer formulations may secure market share and mitigate legal risks [2].
• Regulatory Climate: Enhanced oversight could either constrain sales or, alternatively, position ABSTRAL as a safer option if reformulated appropriately.
• Reimbursement Policies: Favorable coverage by insurers and government healthcare programs remains essential. Cost-effectiveness analyses highlighting the drug's rapid relief and safety profile can influence inclusion in formularies.

In financial terms, the analgesics segment's CAGR is projected at approximately 4-6% through 2027, with opioids contributing significantly, although growth is tempered by the ongoing opioid epidemic and corresponding regulations [3]. ABSTRAL’s revenues are expected to reflect these market sentiments, with potential upticks through strategic positioning and development of next-generation formulations.

Market Challenges and Opportunities

Challenges:

• Heightened regulatory oversight and potential for misuse leading to tighter prescribing restrictions
• Public and legislative pushback against opioid dependence risks
• Competition from alternative pain management therapies, including non-opioid modalities

Opportunities:

• Development of abuse-deterrent formulations aligning with regulatory expectations
• Expanding indications to include other pain syndromes under strict controls
• Growing global burden of cancer and chronic pain conditions increasing overall market size

Global Market Expansion

Despite restrictions in North America, emerging markets present growth prospects driven by increasing cancer prevalence, rising healthcare infrastructure, and greater acceptance of opioid therapy under appropriate safeguards. Strategic partnerships with local distributors and regulatory agencies are pivotal for successful expansion, considering cross-border regulatory variations.

Conclusion

ABSTRAL’s market dynamics are intricate, influenced by a confluence of clinical demand, regulatory oversight, competitive positioning, and societal factors related to the opioid epidemic. While current revenues face headwinds, strategic innovation, regulatory compliance, and expanding global markets offer avenues for sustained growth. Financial projections suggest cautious optimism, contingent on healthcare policies evolving to balance effective pain management with mitigation of misuse risks.

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Key Takeaways

• ABSTRAL remains a specialized, rapid-onset opioid analgesic with steady demand in breakthrough cancer pain management.
• Market growth is constrained by stricter opioid regulations and evolving prescribing practices amid the opioid crisis.
• Future revenue depends on product innovation, regional expansion, and navigating regulatory compliance.
• Adoption of abuse-deterrent formulations could strengthen ABSTRAL’s market position and address regulatory concerns.
• Emerging markets offer substantial growth opportunities, contingent on effective regulatory strategies and healthcare infrastructure development.

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FAQs

1. What differentiates ABSTRAL from other fentanyl formulations?
ABSTRAL's sublingual delivery provides rapid absorption, offering quick pain relief suitable for breakthrough pain episodes. Its convenient, non-invasive route enhances patient compliance relative to injectable options.

2. How has the opioid epidemic impacted ABSTRAL's market?
The epidemic has led to tighter prescribing regulations and increased scrutiny, reducing some demand but prompting manufacturers to develop abuse-deterrent formulations to maintain market relevance.

3. Are there upcoming developments or formulations for ABSTRAL?
While specific pipeline updates are proprietary, the industry trend favors abuse-deterrent versions of fentanyl products to enhance safety and regulatory compliance, which could positively influence ABSTRAL’s future trajectory.

4. What regions show the most promise for ABSTRAL’s growth?
Emerging markets like Asia Pacific and Latin America offer significant growth potential due to rising cancer prevalence and improving healthcare access, provided regulatory and distribution challenges are managed.

5. How does reimbursement affect ABSTRAL’s sales?
Insurance coverage and reimbursement policies are crucial. Inclusion in formularies and favorable cost-effectiveness evaluations can expand its prescribing base and revenue stream.

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References

[1] MarketsandMarkets, Pain Management Market Forecast, 2022-2027.
[2] U.S. FDA, Guidance on Abuse-Deterrent Opioids, 2021.
[3] IQVIA, Global Opioid Market Report, 2022.