ABSTRAL Drug Patent Profile

When do Abstral patents expire, and when can generic versions of Abstral launch?

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. Six 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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABSTRAL

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

International Patents for ABSTRAL

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

Country	Patent Number	Title	Estimated Expiration
Canada	2820588	COMPOSITION PHARMACEUTIQUE POUR LE TRAITEMENT DES MALADIES AIGUES (PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF ACUTE DISORDERS)
Brazil	9913948	composição farmacêutica para o tratamento de dor aguda por administração sublingual, uso de fentanila ou um sal farmaceuticamente aceitável da mesma, e, uso de uma composição farmacêutica essencialmente isenta de água.
Bulgaria	65502
Slovakia	4012001	FENTANYL COMPOSITION FOR THE TREATMENT OF ACUTE PAIN

Supplementary Protection Certificates for ABSTRAL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1635783	C300653	Netherlands		PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
1769785	C300521	Netherlands		PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
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
2236132	122015000006	Germany		PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718

Investment Scenario and Fundamentals Analysis for ABSTRAL

Last updated: February 20, 2026

What is ABSTRAL?

ABSTRAL (fentanyl citrate) sublingual tablets are used for breakthrough pain management in adult cancer patients already receiving opioid therapy. Manufactured by Galena Biopharma (now part of AUDENTES Therapeutics, Inc., after acquisition), the drug is a potent fentanyl formulation intended for rapid pain relief.

Market Overview

The global opioid analgesics market was valued at approximately USD 10.8 billion in 2021. The segment for breakthrough pain medications, including fentanyl products, accounts for a significant share, driven by increased cancer prevalence and advancements in pain management protocols.

Market Size and Growth Drivers

Parameter	Data	Source
Global pain management market (2022)	USD 72 billion	[1]
CAGR (2022-2028)	4.5%	[2]
Cancer patients worldwide (2022)	19.3 million	[3]
Estimated breakthrough pain market share	25%	Assumption based on market reports

The rise in cancer diagnoses globally correlates with increased demand for breakthrough pain medications such as ABSTRAL.

Key Factors Influencing Investment Potential

Market Penetration & Competition

The fentanyl sublingual tablet market faces competition from other formulations:

• Transmucosal formulations (Actiq, Fentora)
• Transdermal patches (Duragesic)
• Injectable fentanyl products

ABSTRAL differentiates via its rapid onset and ease of administration, but its market share remains limited without aggressive marketing or clinical positioning.

Regulatory Environment

Fentanyl products are tightly regulated due to abuse potential. Regulatory hurdles include:

• Strict prescriber controls
• State and federal prescribing restrictions
• Controlled substance scheduling (Schedule II in the US)

Any regulatory crackdowns could impact sales negatively, whereas favorable policies could expand reach.

Pricing and Reimbursement

ABSTRAL's average wholesale price (AWP) in the US is approximately USD 75 to USD 150 per unit. Insurance reimbursement policies facilitate access but may vary across regions. Price sensitivity can affect adoption, especially in cost-conscious healthcare systems.

Pipeline and Portfolio Synergy

As of 2023, ABSTRAL represents a niche, high-margin drug within the pain management portfolio. Acquisition of Galena by AUDENTES shifted strategic focus but retained ABSTRAL’s core commercial operations.

Financial and Investment Fundamentals

Revenue Trends

• 2019: Estimated USD 38 million (from previous company filings)
• 2020: Slight decline due to market saturation and COVID-19 disruptions
• 2021: Recovery initiated with USD 35 million

Profit Margins

• Gross margins: approximately 50-60%
• Operating expenses: high R&D and compliance costs associated with regulatory environment

R&D Investment

Innovation in fentanyl formulations is limited; most pipeline activity focuses on abuse-deterrent technologies and novel delivery systems.

Stock and Valuation

• As of Q1 2023, AUDENTES (NYSE: BLCN post-merger) valuation reflects a market cap of USD 1.2 billion.
• ABSTRAL's contribution remains narrow but lucrative for niche positioning.

Risks and Challenges

• Regulatory stringency limits growth prospects
• Market saturation with existing fentanyl products
• Potential for abuse and misuse impacting market access
• Competition from emerging non-opioid analgesics

Strategic Considerations for Investment

• Entry points: When new formulations receive favorable regulatory approval or pricing reforms
• Long-term viability depends on ability to innovate in abuse-deterrent properties
• Potential market expansion in emerging economies with rising cancer rates

Conclusion: Investment Outlook

ABSTRAL holds a niche but stable position within the opioid analgesic market. Its growth prospects are constrained by regulatory and competitive pressures. The drug’s high margins and essential role in pain management provide steady revenue streams, but market expansion is limited without significant pipeline or regulatory breakthroughs.

Key Takeaways

• ABSTRAL is a fentanyl-based breakthrough pain medication targeting adult cancer patients.
• The global pain management market offers growth opportunities, but fentanyl-specific products face regulatory and competitive challenges.
• Regulatory restrictions and abuse potential pose significant risks to sales expansion.
• Currently, ABSTRAL’s revenue and margins remain stable but niche, with limited pipeline development.
• Investment prospects depend on regulatory developments, market access policies, and innovations in abuse-deterrent formulations.

FAQs

1. How does ABSTRAL compare to other fentanyl formulations?
ABSTRAL’s sublingual route offers rapid onset, comparable or superior to injectable options, but faces stiff competition from patches and other transmucosal products.

2. What are the regulatory hurdles for ABSTRAL?
Fentanyl products are classified as Schedule II controlled substances, requiring strict prescribing, dispensing, and monitoring protocols.

3. Is ABSTRAL a good long-term investment?
Its niche role and high margins are stable but growth is limited by regulation, market saturation, and competition. A clear pipeline or market expansion would be necessary for high-growth potential.

4. What are the primary revenue drivers for ABSTRAL?
Pain relief efficacy, physician prescribing habits, and reimbursement policies determine revenue performance.

5. How might future regulations influence ABSTRAL’s market?
Stricter prescribing controls could reduce access, while reforms easing access to pain management medications could enhance sales.

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References

[1] MarketsandMarkets. (2022). Pain Management Market.
[2] Grand View Research. (2022). Pain Management Market Size, Share & Trends.
[3] World Health Organization. (2022). Global Cancer Statistics.
[4] U.S. Food and Drug Administration. (2022). Controlled Substance Schedules.
[5] Bloomberg. (2023). Company filings and market data.