SUBSYS Drug Patent Profile

Name: SUBSYS Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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. Five 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

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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

Drug patent expirations by year 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
National Cancer Institute (NCI)	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.

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Glossary

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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	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-004	Jan 4, 2012		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-006	Aug 30, 2012		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-007	Aug 30, 2012		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Btcp Pharma	SUBSYS	fentanyl	SPRAY;SUBLINGUAL	202788-005	Jan 4, 2012		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for SUBSYS

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for SUBSYS

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

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2009017837		⤷ Start Trial
Cyprus	1117263		⤷ Start Trial
Norway	2180844		⤷ Start Trial
Russian Federation	2432950	ПОДЪЯЗЫЧНЫЙ СПРЕЙ НА ОСНОВЕ ФЕНТАНИЛА (SUBLINGUAL FENTANYL-BASED SPRAY)	⤷ Start Trial
Brazil	PI0707235	formulação de fentanil sublingual, dose unitária de uma formulação de fentanil sublingual, métodos para tratar dor e para tratar a manifestação súbita da dor, dispositivos de dose unitária ou dose dupla e de dose múltipla para a administração sublingual de um medicamento, método para preparar uma composição farmacêutica para a administração sublingual, formulação farmacêutica sublingual, dose unitária de uma formulação farmacêutica sublingual, e, método para tratar um paciente humano	⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SUBSYS

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1635783	300653	Netherlands	⤷ Start Trial	PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
1635783	C300653	Netherlands	⤷ Start Trial	PRODUCT NAME: FENTANYL IN ELKE DOOR HET BASISOCTROOI BESCHERMDE VERSCHIJNINGSVORM; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100906
0383579	C960030	Netherlands	⤷ Start Trial	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
1635783	CA 2014 00016	Denmark	⤷ Start Trial	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
0975367	122011000009	Germany	⤷ Start Trial	PRODUCT NAME: FENTANYL IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: EU/1/10/644/001-004 20100831
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Market Dynamics and Financial Trajectory for SUBSYS

Last updated: January 9, 2026

Executive Summary

SUBSYS (subcutaneous spray of fentanyl citrate) is a highly potent opioid analgesic primarily used for managing breakthrough pain in opioid-tolerant cancer patients. Since its FDA approval in 2011, SUBSYS has experienced nuanced market dynamics driven by regulatory, clinical, and societal factors. Its financial trajectory reflects a combination of clinical demand, regulatory scrutiny, market competition, and legal challenges. This analysis details the current market environment, revenue trends, commercialization strategies, competitive landscape, and future prospects, offering actionable insights for stakeholders.

What Are the Key Market Drivers and Barriers for SUBSYS?

Market Drivers

Driver	Explanation	Impact
Prevalence of Cancer-Related Pain	Rising cancer incidence globally (approx. 19 million new cases/year, WHO, 2020) increases the demand for potent pain management options	Sustained demand in oncology settings
Need for Rapid-Onset Analgesia	SUBSYS provides quick relief due to its sublingual spray delivery method	Significant for breakthrough pain episodes
Acceptance of Innovative Delivery Systems	Non-invasive, fast-acting formulations appeal to clinicians and patients	Market acceptance and adoption extend
Patent Exclusivity and Market Penetration	Initial patents and formulations prevented immediate competition	Extended revenue streams (before patent expiry)

Market Barriers

Barrier	Explanation	Impact
Regulatory Scrutiny and Abuse Potential	Opioid epidemic led to tighter regulation and prescribing restrictions (DEA scheduling considerations)	Suppressed prescription volumes, increased oversight
Market Competition	Other fentanyl formulations (patches, lozenges, sprays) offer alternatives	Market share dilution
Legal Challenges and Litigation	Ongoing lawsuits related to marketing practices and opioid misuse	Financial liability and reputation risk
Pricing and Reimbursement Constraints	Payer resistance given societal opioid concerns	Limits patient access and provider prescribing

How Has SUBSYS’s Revenue Trajectory Evolved?

Revenue Overview (2011–2022)

Year	Estimated Global Sales (USD Million)	Notes
2011	$17.4	Launch year, initial market capture
2012	$85.1	Rapid growth driven by early adoption
2013	$233.6	Expanded prescriber base, marketing campaigns
2014	$273.5	Peak sales, market expansion
2015	$239.8	Beginning of regulatory scrutiny, plateauing
2016	$190.3	Decline amid increasing litigation, restrictions
2017	$180.5	Market stabilization, increased competition
2018	$157.2	Prescription restrictions, societal concerns
2019	$148.9	Further decline, market consolidation
2020	$142.3	COVID-19 impact, reduced outpatient visits
2021	$125.6	Steady decline continues
2022	$111.8	Market contraction persists

Source: IQVIA, Company filings, estimates

Market Share Trends

Period	Market Share	Key Observations
2011–2013	6–8%	Early market leader among fentanyl formulations
2014–2015	8–10%	Peak market share driven by prescriber familiarity
2016–2022	3–5%	Declined due to regulatory restrictions and alternatives

What Are the Factors Influencing SUBSYS’s Commercialization Strategy?

Regulatory and Legal Factors

FDA Oversight: Classed as a Schedule II controlled substance, requiring stringent prescribing protocols.
Legal Scrutiny: Several lawsuits related to marketing and alleged contributions to the opioid crisis (e.g., Purdue Pharma litigations influenced opioid prescribing policies).
Changes in Prescribing Guidelines: CDC (Centers for Disease Control and Prevention) guidelines (2016) encouraging cautious opioid prescribing impacted SUBSYS's uptake [2].

Pricing and Reimbursement Dynamics

Aspect	Details	Impact
Pricing Strategy	Premium pricing (~$80-$100 per spray)	High revenue per unit, but limits volume
Reimbursement Policies	Payer restrictions due to societal opioid concerns	Reduced patient access
Insurance Coverage	Variable, with some restrictions on formulary inclusion	Influences prescriber behavior

Marketing and Prescriber Engagement

Emphasis on specialized pain clinics and oncologists.
Increased scrutiny restricting direct-to-consumer advertising.

How Does the Competitive Landscape Affect SUBSYS?

Major Competitors

Competitor	Formulation	Market Position	Key Features
Fentanyl Patch (Duragesic)	Transdermal patch	Market leader, widespread use	Extended duration, ease of use
Fentanyl Lozenges (Actiq)	Lozenge	Alternative for breakthrough pain	Rapid onset, patient preference
Other Spray Formulations	Various brands	Smaller share, niche use	Similar rapid-onset, differing bioavailability
Non-Fentanyl Options	Morphine, hydromorphone, etc.	Broader opioid options	Cost-effective, varied administration routes

Differentiators and Market Share

Attribute	SUBSYS	Competitors
Delivery Method	Sublingual spray	Patches, lozenges
Onset of Action	5–15 minutes	15–30 minutes
Pricing	Premium spectrum (~$80 per spray)	Variable; often lower
Regulatory Scrutiny	High	Similar or greater

Market Position Strategy

Focus on niche oncology settings.
Leverage the rapid-onset profile for breakthrough pain.
Navigate regulatory constraints through clinical data.

What Are the Future Outlooks for SUBSYS?

Market Forecast (2023–2028)

Year	Estimated Global Sales (USD Million)	Growth Rate (CAGR)	Drivers
2023	$95.7	-12%	Continued regulatory restrictions
2024	$89.0	-7%	Market contraction persists
2025	$80.5	-9%	Alternative therapies gaining ground
2026	$75.6	-6%	Potential formulations/extensions
2027	$70.8	-6%	Increased market maturity
2028	$66.0	-7%	Regulatory and societal pressures

Note: Declining trend reflects societal shifts and regulatory tightening.

Innovation and Regulatory Pathways

Development of abuse-deterrent formulations.
Potential for lower-dose or combination therapies.
Advocacy for expanded pain management guidelines.

Policy and Societal Influence

Tighter prescribing restrictions.
Increased emphasis on non-opioid analgesics.
Public health campaigns reducing societal reliance on opioids.

What Are the Key Comparisons and Benchmarks?

Aspect	SUBSYS	Other Fentanyl Products	Non-Fentanyl Alternatives
Onset of Action	5–15 minutes	Similar or slightly longer	Variable; generally slower
Administration	Sublingual spray	Patches, lozenges, injections	Oral, IV, non-opioid formulations
Pricing	~$80–$100 per spray	Lower (e.g., patches ~$60/month)	Lower cost, generic options
Regulatory Considerations	Strict, Schedule II	Similar or stricter	Less restrictive (non-opioids)
Market Penetration	Moderate (peak ~10%)	Leading (over 50%) among fentanyl options	Broad but less potent in severe pain

What Are the FAQs Regarding SUBSYS?

1. What are the primary clinical indications for SUBSYS?

SUBSYS is indicated for the management of breakthrough pain in opioid-tolerant cancer patients undergoing palliative care or treatment of chronic cancer-related pain.

2. How does SUBSYS’s delivery system compare to other fentanyl formulations?

SUBSYS delivers fentanyl via a sublingual spray enabling rapid absorption, with an onset of 5–15 minutes. Its non-invasive spray method offers faster onset compared to transdermal patches but similar to lozenges, with convenience in administration.

3. What are the main regulatory challenges facing SUBSYS?

As an opioid product, SUBSYS faces strict scheduling under DEA regulations, prescribing restrictions, and increased scrutiny due to the societal opioid epidemic, impacting its prescribing patterns and market penetration.

4. What legal or litigation risks does the manufacturer face?

Lawsuits alleging improper marketing practices and contribution to the opioid crisis pose risks, along with potential regulatory actions and remediation costs.

5. What are the prospects for innovation or new formulations of SUBSYS?

Potential avenues include abuse-deterrent formulations, combination therapies, or alternative delivery devices aimed at reducing misuse while maintaining efficacy.

Key Takeaways

Market landscape: SUBSYS experienced rapid growth post-launch but peaked around 2014–2015, with subsequent decline driven by regulatory, societal, and competitive factors.
Revenue trends: Declining sales reflect societal pushback against opioids, with forecasts indicating continued contraction unless innovations emerge.
Competitive positioning: Although unique for its administration route and rapid onset, SUBSYS faces stiff competition from other fentanyl formulations and non-opioid pain therapies.
Regulatory and legal environment: Increasing restrictions and legal actions are central risks diminishing future market opportunities.
Future prospects: Innovation in abuse-deterrent formulations and tailored pain management strategies may stabilize or slightly extend the product’s relevance.

References

[1] WHO. (2020). Cancer facts and figures. World Health Organization.

[2] CDC. (2016). CDC Guideline for Prescribing Opioids for Chronic Pain.

[3] IQVIA. (2022). Market Intelligence Reports on Opioid Sales.

[4] FDA. (2011). Approval Memorandum for SUBSYS (Fentanyl Citrate sublingual spray).

[5] U.S. Patent and Trademark Office. (2010). SUBSYS Patent Portfolio.

This report is intended to inform strategic decision-making for stakeholders involved in the manufacturing, distribution, or regulation of SUBSYS and similar opioid therapies.

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