XTAMPZA ER Drug Patent Profile

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

Xtampza Er is a drug marketed by Collegium Pharm Inc and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-four patent family members in thirteen countries.

The generic ingredient in XTAMPZA ER is oxycodone. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the oxycodone profile page.

DrugPatentWatch^® Generic Entry Outlook for Xtampza Er

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 2, 2036. This may change due to patent challenges or generic licensing.

There have been seven 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 four tentative approvals for the generic drug (oxycodone), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XTAMPZA ER

International Patents:	24
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	2
Drug Prices:	Drug price information for XTAMPZA ER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XTAMPZA ER
DailyMed Link:	XTAMPZA ER at DailyMed

See drug prices for XTAMPZA ER

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for XTAMPZA ER

Constraining patent/regulatory exclusivity:

9,737,530

NDA:

208090

Dosage:

CAPSULE, EXTENDED RELEASE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for XTAMPZA ER

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

Sponsor	Phase
Ajay Wasan, MD, Msc	Phase 4
Collegium Pharmaceutical, Inc.	Phase 4
University of Alabama at Birmingham	Early Phase 1

See all XTAMPZA ER clinical trials

Pharmacology for XTAMPZA ER

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Paragraph IV (Patent) Challenges for XTAMPZA ER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
XTAMPZA ER	Extended-release Capsules	oxycodone	9 mg, 13.5 mg, 18 mg, 27 mg and 36 mg	208090	1	2017-11-15

US Patents and Regulatory Information for XTAMPZA ER

XTAMPZA ER is protected by twelve US patents.

This potential generic entry date is based on patent 9,737,530.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-004	Apr 26, 2016		RX	Yes	No	10,646,485		Y
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016		RX	Yes	No	10,668,060		Y
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-005	Apr 26, 2016		RX	Yes	Yes	9,968,598		Y
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-005	Apr 26, 2016		RX	Yes	Yes	8,557,291		Y
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-004	Apr 26, 2016		RX	Yes	No	8,557,291		Y
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-005	Apr 26, 2016		RX	Yes	Yes	10,188,644		Y
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-005	Apr 26, 2016		RX	Yes	Yes	9,682,075		Y

Expired US Patents for XTAMPZA ER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-005	Apr 26, 2016	8,758,813
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-001	Apr 26, 2016	9,248,195
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016	7,771,707
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016	10,525,052
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-004	Apr 26, 2016	8,449,909
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016	8,840,928
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016	9,044,398

International Patents for XTAMPZA ER

See the table below for patents covering XTAMPZA ER around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2009298822	ABUSE-DETERRENT PHARMACEUTICAL COMPOSITION ON OPIOID AND OTHER DRUG
Japan	2015166402	オピオイドおよび他の薬物に関する乱用抑止性の薬学的組成物 (ABUSE-DETERRENT PHARMACEUTICAL COMPOSITIONS OF OPIOIDS AND OTHER DRUGS)
Poland	1765292
Slovenia	1765292
Denmark	1765292
European Patent Office	1594467	COMPOSITIONS PHARMACEUTIQUES D'OPIOIDES ET D'AUTRES MEDICAMENTS EMPECHANTS LES UTILISATIONS ABUSIVES (ABUSE-DETERRENT PHARMACEUTICAL COMPOSITIONS OF OPIOIDS AND OTHER DRUGS)
Japan	2015166402

Supplementary Protection Certificates for XTAMPZA ER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	92292	Luxembourg		PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE

Market Dynamics and Financial Trajectory for XTAMPZA ER

Last updated: July 28, 2025

Introduction

XTAMPZA ER (oxycodone extended-release), developed by Collegium Pharmaceutical, represents a notable entrant in the opioid analgesic market. Approved by the FDA in 2016, the drug is designed to treat moderate to severe chronic pain in opioid-tolerant adults. Its unique formulation aims to mitigate abuse potential while delivering sustained pain relief, positioning it within the complex landscape of opioid therapeutics amid increasing scrutiny over opioid misuse and regulatory oversight. This analysis explores the market dynamics, competitive landscape, regulatory considerations, and financial trajectory shaping XTAMPZA ER’s trajectory.

Market Landscape and Demand Drivers

Rising Prevalence of Chronic Pain

Chronic pain affects approximately 20% of adults globally, translating into a massive market for opioid-based analgesics. In the U.S., where opioid prescriptions are prevalent, the demand for effective, abuse-deterrent formulations remains high. According to the CDC, opioids accounted for over 16,000 deaths in 2020 alone, underscoring the need for safer analgesics, which XTAMPZA ER aims to address through its abuse-deterrent technology (ADT).

Preference for Abuse-Deterrent Formulations

Public health initiatives and regulatory agencies have catalyzed a shift toward abuse-deterrent opioids. The FDA encourages the development of formulations that reduce tampering and misuse. XTAMPZA ER leverages a combination of physicochemical properties and delivery mechanisms designed to resist crushing and injection, granting it a competitive advantage among patients and prescribers seeking safer options.

Growth in Prescription Volumes

The U.S. opioid prescription volume has fluctuated due to tight regulations and increased awareness. Notably, the total prescriptions for opioid analgesics declined roughly 20% from 2012 to 2021 but remained sizable, with approximately 77 million opioid prescriptions dispensed in 2020 (IQVIA data). XTAMPZA ER benefits from this baseline demand while targeting clinicians seeking safer options amid an evolving regulatory environment.

Competitive Landscape

Key Competitors

• OxyContin (Purdue Pharma): As a long-acting oxycodone, OxyContin remains a dominant player, although facing patent expirations and increasing scrutiny.
• Xtampza ER’s Abuse-Deterrent Edge: Its unique formulation offers a competitive advantage, especially for prescribers prioritizing abuse-deterrence.
• Other Abuse-Deterrent opioids: Reformulations of generic oxycodone and hydrocodone have entered the market, although often with less robust abuse-deterrent features.

Differentiators

• Formulation Technology: Xtampza ER uses Microspheres technology, resistant to crushing/tampering (as demonstrated in clinical studies).
• Pricing and Reimbursement: It commands a premium over generics, supported by formulary positioning and patient access programs.
• Prescriber Adoption: Clinical guidelines and provider education are crucial for market penetration, especially amid opioid-prescribing risks.

Regulatory and Legal Factors

FDA Abuse-Deterrent Labeling

XTAMPZA ER received abuse-deterrent labeling from the FDA, an essential marker impacting prescribing behavior and reimbursement policies. Abuse-deterrence labels contribute to formulary acceptance and long-term market share growth.

Legal Challenges

Like other opioids, XTAMPZA ER faces potential litigation risks related to opioid epidemic liability. Collegium actively manages compliance and positions the drug within the safety-conscious framework increasingly demanded by policymakers.

Reimbursement Environment

Insurance coverage significantly influences sales volume. The drug’s positioning as a safer alternative allows for favorable formulary placement, though prior authorization requirements may apply, introducing access barriers that could impact revenue.

Market Penetration and Adoption Strategies

Collegium has invested in educational campaigns targeting pain specialists and pharmacists, emphasizing XTAMPZA ER's abuse-deterrent features. The company also seeks strategic partnerships to expand access and improve formulary positioning. External factors like reimbursement policies and prescriber guidelines will heavily influence its foothold.

Financial Trajectory Analysis

Sales Performance and Revenue Trends

Since its launch, XTAMPZA ER has experienced modest but steady growth. Initial sales were constrained by limited awareness and insurance hurdles, but recent data indicate increased adoption, driven by expanded formulary inclusion and improved prescriber familiarity.

• In 2021, XTAMPZA ER generated approximately $60 million in worldwide sales, marking a positive inflection from initial launch figures (Collegium's financial disclosures).
• Year-over-year growth rate approximates 15-20%, with potential to accelerate upon wider acceptance and increased prescriber education.

Profitability Outlook

Although still in a growth phase, XTAMPZA ER benefits from high gross margins typical of specialty pharmaceuticals. However, substantial R&D, marketing, and regulatory compliance costs impact profitability in the short term. As market penetration deepens and fixed costs are amortized, Collegium expects margin expansion.

Pipeline and Expansion Opportunities

• New Formulations: Development of alternative formulations for different pain indications.
• Geographic Expansion: Entry into European and Asian markets subject to regulatory approval.
• Adjunct Indications: Potential extensions into oncology or other chronic pain subsets.

Risks Impacting Financial Trajectory

• Regulatory Changes: Potential tightening of opioid prescribing norms could curb demand.
• Litigation Risks: Ongoing legal challenges could impose penalties or restrict sales.
• Market Entrants: Patent expirations and generic formulations could erode market share.
• Reimbursement Policies: Shifts favoring non-opioid pain treatments could challenge growth.

Future Outlook and Sector Trends

The trajectory for XTAMPZA ER hinges upon broader opioid market dynamics, evolving regulatory environments, and patient-centric safety initiatives. While the acute market segment may plateau as alternatives gain popularity, the segment of patients with chronic pain requiring long-term opioid therapy remains sizable. Building on abuse-deterrent features and expanding prescriber acceptance could enable Collegium to capture a significant share.

Advances in digital health, remote monitoring, and personalized pain management may also catalyze shifts in treatment paradigms, influencing XTAMPZA ER’s demand. Moreover, policy trends favoring opioid formulations with abuse-deterrent properties suggest a resilient market position.

Key Takeaways

• XTAMPZA ER benefits from high unmet need in prescription opioid safety, with abuse-deterrent technology providing a competitive edge.
• Market growth is driven by increasing awareness of opioid misuse, regulatory push for abuse-resistant formulations, and substantial demand for chronic pain management.
• Reimbursement and formulary strategies are critical to expanding market share; robust prescriber education enhances adoption.
• Financial growth prospects are promising, with revenue expected to increase as penetration deepens and market acceptance gains momentum.
• Risks such as regulatory shifts, litigation, and market competition necessitate active management and strategic positioning.

FAQs

1. How does XTAMPZA ER differentiate itself from other oxycodone formulations?
XTAMPZA ER employs Microspheres technology that resists crushing and tampering, offering enhanced abuse-deterrent properties compared to traditional formulations. Its FDA-approved abuse-deterrent label further distinguishes it in a crowded market.

2. What is the current market size and growth potential for XTAMPZA ER?
The U.S. opioid analgesic market exceeds $12 billion annually, with abuse-deterrent formulations comprising a growing segment. XTAMPZA ER’s sales, around $60 million in 2021, are poised for growth as prescriber awareness and formulary acceptance expand, potentially reaching over $150 million within five years.

3. What regulatory challenges could impact XTAMPZA ER’s market trajectory?
Regulatory agencies continue to evaluate the efficacy of abuse-deterrent labels, and future legislation could restrict opioid prescribing or promote alternative therapies, affecting demand adversely.

4. How does Collegium plan to grow XTAMPZA ER’s market presence?
Strategic initiatives include expanding insurance coverage, increasing prescriber education, pursuing geographic expansion, and developing new formulations tailored to different pain management needs.

5. What are the key risks facing XTAMPZA ER in the evolving opioid landscape?
Risks include regulatory crackdowns, litigation related to the opioid epidemic, patent cliffs leading to generics, and shifts towards non-opioid treatments, all of which could suppress future revenue.

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Sources

[1] CDC. "Drug Overdose Deaths," 2022.
[2] IQVIA. "Opioid Prescribing Trends," 2021.
[3] Collegium Pharmaceutical. "Financial Reports," 2021.
[4] U.S. Food and Drug Administration. "Abuse-Deterrent Labeling," 2016.