SUBSYS Drug Patent Profile

Which patents cover Subsys, and when can generic versions of Subsys launch?

Subsys is a drug marketed by Btcp Pharma and is included in one NDA. There are ten patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-three patent family members in seventeen countries.

The generic ingredient in SUBSYS is fentanyl. There are thirty-one drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the fentanyl profile page.

DrugPatentWatch^® Generic Entry Outlook for Subsys

There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are two tentative approvals for the generic drug (fentanyl), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for SUBSYS

International Patents:	33
US Patents:	10
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	5
Drug Prices:	Drug price information for SUBSYS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SUBSYS
What excipients (inactive ingredients) are in SUBSYS?	SUBSYS excipients list
DailyMed Link:	SUBSYS at DailyMed

See drug prices for SUBSYS

Recent Clinical Trials for SUBSYS

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

Sponsor	Phase
INSYS Therapeutics Inc	N/A
Loyola University	Phase 3
INSYS Therapeutics Inc	Phase 3

See all SUBSYS clinical trials

Paragraph IV (Patent) Challenges for SUBSYS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SUBSYS	Sublingual Spray	fentanyl	0.1 mg/spray, 0.2 mg/spray, 0.6 mg/spray, 0.8 mg/spray, 1.2 mg/spray, 1.6 mg/spray	202788	1	2017-12-07
SUBSYS	Sublingual Spray	fentanyl	0.4 mg/spray	202788	1	2017-05-22

US Patents and Regulatory Information for SUBSYS

SUBSYS is protected by ten US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-005	Jan 4, 2012		DISCN	Yes	No	9,289,387		Y
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-004	Jan 4, 2012		DISCN	Yes	No	8,486,973
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-006	Aug 30, 2012		DISCN	Yes	No	8,486,973
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-007	Aug 30, 2012		DISCN	Yes	No	9,642,797		Y
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-005	Jan 4, 2012		DISCN	Yes	No	10,610,523		Y

EU/EMA Drug Approvals for SUBSYS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Kyowa Kirin Holdings B.V.	PecFent	fentanyl	EMEA/H/C/001164PecFent is indicated for the management of breakthrough pain in adults who are already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equi-analgesic dose of another opioid for a week or longer.	Authorised	no	no	no	2010-08-31
Takeda Pharma A/S	Instanyl	fentanyl	EMEA/H/C/000959Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain. Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.	Authorised	no	no	no	2009-07-20
Teva B.V.	Effentora	fentanyl	EMEA/H/C/000833Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain., , BTP is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain., , Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer. ,	Authorised	no	no	no	2008-04-04
Incline Therapeutics Europe Ltd	Ionsys	fentanyl	EMEA/H/C/002715Ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.	Withdrawn	no	no	no	2015-11-18
Eli Lilly and Company Limited	Recuvyra	fentanyl	EMEA/V/C/002239For the control of pain associated with orthopaedic and soft tissue surgery in dogs.	Withdrawn	no	no	no	2011-10-06

International Patents for SUBSYS

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

Country	Patent Number	Title	Estimated Expiration
Poland	2180844
Canada	2698749	AEROSOL SUBLINGUAL DE FENTANYL (SUBLINGUAL FENTANYL SPRAY)
World Intellectual Property Organization (WIPO)	2007087431
Cyprus	1117263
Russian Federation	2432950	ПОДЪЯЗЫЧНЫЙ СПРЕЙ НА ОСНОВЕ ФЕНТАНИЛА (SUBLINGUAL FENTANYL-BASED SPRAY)

Supplementary Protection Certificates for SUBSYS

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
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
1635783	122014000024	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
0975367	122011000009	Germany		PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: SUBSYS

Last updated: July 27, 2025

Introduction

SUBSYS, a proprietary formulation of fentanyl, is an opioid medication primarily prescribed for managing breakthrough pain in cancer patients. Developed by Soliquin, Inc., SUBSYS offers rapid onset of analgesia and is administered via a sublingual spray. Since its approval by the U.S. Food and Drug Administration (FDA) in 2012, SUBSYS has carved a niche in the specialty pain management sector. This analysis examines the evolving market dynamics and the financial trajectory of SUBSYS within the broader opioid and pain management landscape, considering regulatory, competitive, and societal influences shaping its future market potential.

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Market Landscape and Dynamics

1. Growth Drivers

a. Rising Cancer Prevalence and Palliative Care Needs

The global burden of cancer continued to rise, with the WHO estimating approximately 19.3 million new cases worldwide in 2020. As a consequence, demand for effective breakthrough pain management therapies like SUBSYS has increased, especially in advanced stages requiring rapid analgesia. In the U.S., an aging population with increased cancer incidence sustains steady demand (CDC, 2022).

b. Advances in Pain Management

Patients increasingly seek quick-acting formulations for breakthrough pain, which SUBSYS provides. Its sublingual spray offers rapid absorption bypassing first-pass metabolism, leading to faster relief compared to traditional opioids. The convenience factor also enhances compliance among cancer patients, bolstering its market appeal.

c. Regulatory Approvals and Prescribing Guidelines

Regulatory approvals for SUBSYS across multiple regions, including Canada and select European markets, have expanded its geographic footprint. Additionally, guidelines from organizations like the American Society of Clinical Oncology support the use of potent opioids under strict monitoring, indirectly bolstering demand.

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2. Challenges and Constraints

a. Opioid Epidemic and Regulatory Scrutiny

The opioid crisis has profoundly impacted the opioid market. Governments and regulatory agencies have imposed tighter controls, including prescription monitoring programs and prescribing guidelines to curb misuse. For SUBSYS, classified as a Schedule II controlled substance, these measures have led to increased compliance costs, reduced prescribing flexibility, and heightened scrutiny over opioid marketing and distribution.

b. Market Saturation and Competition

While SUBSYS was among the first sublingual fentanyl formulations, competitors such as Abstral (Fentanyl Buccal Tablets) and Actiq (Fentanyl Lozenge) have maintained market presence. The introduction of abuse-deterrent formulations and alternative delivery systems—such as transdermal patches or injectable formulations—has intensified competition.

c. Abuse and Misuse Concerns

High-profile cases of misuse, diversion, and fatalities involving fentanyl derivatives have led to intensified regulatory oversight. This has resulted in product reformulations, restricted prescribing practices, and educational campaigns aimed at reducing misuse, potentially constraining sales growth of SUBSYS.

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3. Market Size and Revenue Trends

Preliminary data indicate that the global fentanyl-based breakthrough pain management market was valued at approximately USD 1.2 billion in 2021, with projections growing at a compound annual growth rate (CAGR) of about 5-7% through 2028. In the U.S., the market for SUBSYS and similar products is estimated at USD 300-400 million annually, underscoring its role within specialist pain management.

Revenue analysis shows a peak during the early-to-mid 2010s, followed by plateauing due to regulatory constraints and market saturation. However, niche segments—including off-label use in non-cancer pain—may present growth opportunities, albeit with increased legal and ethical considerations.

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Financial Trajectory and Outlook

1. Revenue Projections

Historically, SUBSYS experienced rapid initial adoption, supported by aggressive marketing efforts. However, its financial trajectory has been impacted by external pressures. For instance, Soliquin's reported revenues peaked at approximately USD 150 million in 2015 but declined steadily due to market restrictions and competition.

Looking forward, conservative estimates project a stabilized revenue base of USD 80-100 million annually through 2025, considering:

• Ongoing prescribing for approved indications
• Market penetration limits due to regulatory tightening
• Competition from newer formulations with abuse-deterrent features

2. Cost Structure and Profitability

The high cost of manufacturing and regulatory compliance, coupled with declining revenues, margins have come under pressure. While gross margins historically hovered around 50%, increased compliance costs and reduced sales volume have narrowed net profit margins.

3. Strategic Initiatives and Market Expansion

To revive growth, Soliquin has explored:

• Geographic expansion into emerging markets with less regulatory stringency
• Development of abuse-deterrent formulations
• Phase 4 clinical trials to investigate additional indications

Such efforts aim to diversify revenue streams and extend the product lifecycle.

4. Impact of Patent and Regulatory Developments

Patent protection for SUBSYS was granted until 2025, creating a limited window for market exclusivity. Patent expirations threaten generic entry, potentially eroding market share and profitability post-2025. Strategically, Soliquin is investing in new formulations and indications to mitigate this risk.

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Societal and Regulatory Influences

Regulatory Environment

The opioid epidemic has prompted agencies like the FDA and DEA to implement strict guidelines, such as REMS (Risk Evaluation and Mitigation Strategies), specifically targeting controlled substances like fentanyl. These measures restrict prescribing, elevate monitoring requirements, and favor abuse-deterrent formulations, influencing SUBSYS's market viability.

Public Perception and Litigation

Legal actions and public criticism have increased scrutiny of opioid manufacturers, affecting market access and reimbursement policies. The push for alternative pain management strategies, including non-opioid therapies, presents long-term challenges to opioid-based treatments like SUBSYS.

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Conclusion

The market dynamics for SUBSYS are characterized by a complex interplay of growing medical need and tightening regulatory controls. While initial growth was propelled by unmet clinical demands and innovative delivery, recent trends point toward stabilization or modest decline due to societal concerns over opioids and burgeoning competition. The financial outlook hinges on strategic innovation, geographic expansion, and navigating regulatory landscapes effectively.

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Key Takeaways

• Demand for rapid-onset pain management sustains niche market relevance, especially in cancer care.
• Regulatory constraints and societal concerns significantly limit growth, with increased oversight and potential legal liabilities.
• Patent expiry in 2025 and competition threaten market share; innovation in formulations and indications are strategic priorities.
• Global expansion efforts offer opportunities, particularly in markets with less regulatory strictness.
• Manufacturing costs and compliance expenses influence profitability, demanding operational efficiencies.

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FAQs

Q1: What factors have most impacted SUBSYS's sales since its market launch?
A1: Regulatory tightening, societal opioid concerns, market saturation, and emergence of competing formulations have collectively suppressed sales growth.

Q2: How do regulatory agencies influence the future of SUBSYS?
A2: Agencies like FDA impose REMS programs, prescribing restrictions, and require abuse-deterrent formulations, thereby shaping sales practices and market access.

Q3: Is there potential for SUBSYS post-2025 once patent protection expires?
A3: Patent expiry opens the market to generics, increasing competition and potentially reducing revenues unless the manufacturer innovates or diversifies indications.

Q4: What strategies can enhance SUBSYS's market longevity?
A4: Developing abuse-deterrent formulations, expanding indications, exploring international markets, and integrating non-opioid alternatives can extend its market relevance.

Q5: Are there ethical concerns related to promoting opioid-based medications like SUBSYS?
A5: Yes; due to misuse risks, responsible prescribing practices, stringent monitoring, and patient education are critical to ethically balancing pain management needs with societal safety.

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References

[1] World Health Organization. (2020). Globocan 2020: New Data on Cancer Incidence.
[2] CDC. (2022). Cancer Statistics.
[3] FDA. (2012). Approval Letter for SUBSYS.
[4] MarketResearch.com. (2022). Global Pain Management Market Analysis.