XTAMPZA ER Drug Patent Profile

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

Xtampza Er is a drug marketed by Collegium Pharm Inc and is included in one NDA. There are eight 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:	8
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

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 eight US patents.

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			Y
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-004	Apr 26, 2016		RX	Yes	No			Y
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-005	Apr 26, 2016		RX	Yes	Yes			Y
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-004	Apr 26, 2016		RX	Yes	No			Y
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-001	Apr 26, 2016		RX	Yes	No			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	208090-002	Apr 26, 2016
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016

International Patents for XTAMPZA ER

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1765292
Canada	2916869	FORMULATIONS DE PREVENTION DES ABUS (ABUSE-DETERRENT DRUG FORMULATIONS)
Japan	2009298822	ABUSE-DETERRENT PHARMACEUTICAL COMPOSITION ON OPIOID AND OTHER DRUG
World Intellectual Property Organization (WIPO)	2005123039
Spain	2653568

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

Xtampza ER: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is Xtampza ER?

Xtampza ER (oxycodone extended-release) is an opioid analgesic developed by Collegium Pharmaceutical. It is indicated for the management of moderate to severe pain in adults who require continuous, around-the-clock opioid treatment. A key differentiator of Xtampza ER is its abuse-deterrent formulation (ADF), designed to resist manipulation and abuse through crushing, chewing, or injecting. This feature is a critical element in its market positioning and regulatory acceptance. The drug received U.S. Food and Drug Administration (FDA) approval on April 28, 2016 [1].

Therapeutic Indication and Market Positioning

Xtampza ER targets the chronic pain market, a segment characterized by high prevalence and significant unmet needs. The drug's ADF is designed to address concerns surrounding opioid abuse and diversion, a major public health issue. This positioning allows Xtampza ER to compete in a landscape that includes other extended-release opioid formulations, as well as non-opioid pain management alternatives. The presence of abuse-deterrent features is a mandated requirement for new opioid analgesics approved by the FDA since 2015, influencing the competitive environment [2].

Clinical Profile and Efficacy

Xtampza ER is a twice-daily, oral formulation of oxycodone. Its extended-release mechanism is designed to provide sustained pain relief over a 12-hour period. Clinical trials supporting its approval demonstrated comparable efficacy to other FDA-approved extended-release oxycodone products. The ADF technology, OROS, is engineered to release oxycodone in a controlled manner, making it more difficult to extract higher doses for rapid, non-therapeutic administration. This technology has been previously utilized in other pain medications, including Nucynta ER (tapentadol extended-release) [1, 3].

Regulatory Landscape and Abuse Deterrence

The regulatory environment for opioid analgesics is stringent, driven by the opioid crisis. FDA guidance emphasizes the development of abuse-deterrent formulations. Xtampza ER's ADF was designed to meet these evolving requirements. The FDA's approval of Xtampza ER with abuse-deterrent properties was a significant step, recognizing the potential for such formulations to mitigate abuse without compromising therapeutic efficacy for appropriate patients [2, 4]. The labeling of Xtampza ER includes information about its abuse-deterrent properties, differentiating it from non-ADF opioids.

Competitive Analysis

The market for extended-release oxycodone is competitive. Xtampza ER competes with:

• Other Extended-Release Oxycodone Products: These include generic formulations of OxyContin (oxycodone hydrochloride extended-release) and extended-release oxycodone products from other manufacturers. While many generics lack robust abuse-deterrent technology, some newer entrants may incorporate such features.
• Abuse-Deterrent Formulations (ADFs) of Other Opioids: This includes drugs like Embeda (morphine sulfate extended-release), Hysingla ER (hydrocodone bitartrate extended-release), and RoxyBond (oxycodone hydrochloride extended-release).
• Non-Opioid Pain Management Options: This broad category includes NSAIDs, acetaminophen, anticonvulsants, antidepressants, and non-pharmacological therapies. The trend towards reducing opioid prescribing has increased the market share of these alternatives.
• Other Opioid Classes: Drugs like tramadol and tapentadol, which have different mechanisms of action and potentially lower abuse liability than traditional opioids, also represent competitive alternatives.

Xtampza ER's unique selling proposition is its combination of twice-daily dosing and its specific ADF technology, which offers a distinct profile compared to some competitors, particularly those with once-daily dosing or different ADF mechanisms.

Commercialization Strategy

Collegium Pharmaceutical has focused its commercialization efforts on educating healthcare providers and payers about the benefits of Xtampza ER, particularly its abuse-deterrent properties and appropriate use in chronic pain management. The company has aimed to secure favorable formulary placement with health insurers to ensure patient access. Targeted marketing campaigns focus on physicians who manage patients with moderate to severe chronic pain, emphasizing the drug's potential to reduce the risk of abuse and diversion compared to conventional opioid formulations [5].

Sales Performance and Revenue Trajectory

Xtampza ER's sales performance has shown steady growth since its launch.

Year	Net Sales (Millions USD)	Growth (%)
2017	$49.7	N/A
2018	$175.7	253.5%
2019	$327.8	86.6%
2020	$435.7	32.9%
2021	$507.6	16.5%
2022	$570.8	12.5%
2023	$623.7	9.3%

Source: Collegium Pharmaceutical Annual Reports & SEC Filings [6, 7, 8, 9, 10, 11, 12]

The initial rapid growth was driven by market penetration and uptake following its launch. Subsequent growth rates have moderated but remained positive, reflecting ongoing market adoption and Collegium's commercial efforts. The decrease in the percentage growth rate year-over-year is expected as the product matures and faces increasing competition from generics and other pain management solutions.

Financial Performance of Collegium Pharmaceutical

The financial performance of Collegium Pharmaceutical is heavily influenced by Xtampza ER's sales.

Metric (Millions USD)	2021	2022	2023
Revenue	507.6	570.8	623.7
Cost of Goods Sold	90.4	98.9	103.1
Gross Profit	417.2	471.9	520.6
Operating Expenses	374.8	401.5	425.9
Net Income (Loss)	62.8	86.6	107.5

Source: Collegium Pharmaceutical Annual Reports & SEC Filings [10, 11, 12]

Collegium has demonstrated a positive trend in revenue and net income, indicating profitability from its core product. The company's ability to manage its cost of goods sold and operating expenses effectively is crucial for sustaining its financial health and investing in future growth opportunities.

Intellectual Property and Patent Landscape

The patent protection for Xtampza ER is a critical factor for its long-term market exclusivity. Collegium Pharmaceutical holds patents covering the drug itself, its formulation, and its method of use. Key patents include those related to the OROS technology and specific claims on the extended-release oxycodone composition.

The patent expiration dates are a major consideration for future revenue projections and the threat of generic competition. As of late 2023/early 2024, the core patents for Xtampza ER are expected to provide market exclusivity for several more years, though specific expiration dates and potential legal challenges can impact this timeline. The U.S. Patent and Trademark Office (USPTO) and patent litigation play significant roles in determining the extent and duration of market protection [13]. Generic manufacturers typically challenge existing patents to gain market entry. The outcome of such challenges can significantly affect Xtampza ER's revenue post-patent expiry.

Market Outlook and Future Projections

The market outlook for Xtampza ER is influenced by several factors:

• Continued Demand for Pain Management: The prevalence of chronic pain remains high, ensuring a baseline demand for effective pain therapies.
• Regulatory Scrutiny of Opioids: Ongoing concerns about the opioid crisis may lead to further restrictions on opioid prescribing, potentially impacting the overall market size. However, this also creates an environment where ADFs like Xtampza ER are favored.
• Competition: The entry of generic versions of Xtampza ER post-patent expiry will lead to significant price erosion and a reduction in market share. Competition from novel non-opioid pain therapies also poses a threat.
• Collegium's Diversification: Collegium Pharmaceutical is actively pursuing diversification through acquisitions and new product development (e.g., its acquisition of Delysm for cough and cold). This strategy aims to reduce reliance on Xtampza ER and build a more robust portfolio. For instance, the acquisition of BioDelivery Sciences, bringing in products like Elyxyb (lisinopril tablets for migraine) and Utibron Neohaler (indacaterol, glycopyrrolate, and mometasone furoate inhalation powder), signals this strategic shift [14, 15].
• Payer Landscape: Continued formulary access and reimbursement policies from payers will be crucial for maintaining prescription volumes.

Projections for Xtampza ER's revenue will likely show continued modest growth in the near term, followed by a sharp decline upon the introduction of generics. The company's ability to successfully integrate and grow its acquired assets will be key to its long-term financial trajectory.

Key Takeaways

• Xtampza ER is an abuse-deterrent formulation of extended-release oxycodone, approved in 2016 for moderate to severe chronic pain.
• Its abuse-deterrent properties are a key differentiator in a highly regulated opioid market.
• The drug has demonstrated consistent revenue growth, reaching over $600 million in net sales annually.
• Collegium Pharmaceutical has achieved profitability, with net income growing steadily.
• The patent landscape is critical, with the expiration of key patents posing a future threat of generic competition.
• Collegium is actively diversifying its product portfolio through acquisitions to mitigate reliance on Xtampza ER.
• Future revenue projections for Xtampza ER will be shaped by patent expirations, generic entry, and competition from non-opioid alternatives.

FAQs

What is the primary mechanism of action for Xtampza ER?

Xtampza ER contains oxycodone, a semi-synthetic opioid agonist that interacts with opioid receptors in the central nervous system. It also has abuse-deterrent properties designed to resist manipulation.

When is Xtampza ER expected to face generic competition?

The exact timing of generic entry depends on the expiration of all relevant patents and potential patent litigation outcomes. Key patents for Xtampza ER are expected to expire in the mid-to-late 2020s, with potential for earlier challenges.

What is the OROS technology used in Xtampza ER?

OROS (Osmotic Controlled-Release Oral Delivery System) is a proprietary technology that utilizes osmotic pressure to deliver medication at a controlled rate over a specified period. For Xtampza ER, this technology contributes to its extended-release profile and abuse-deterrent characteristics.

What are the main non-opioid alternatives for chronic pain management that compete with Xtampza ER?

Non-opioid alternatives include nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen and naproxen, acetaminophen, anticonvulsants (e.g., gabapentin, pregabalin), antidepressants (e.g., duloxetine, venlafaxine), topical analgesics, and various non-pharmacological therapies such as physical therapy, cognitive behavioral therapy, and acupuncture.

How is Collegium Pharmaceutical addressing the long-term market sustainability beyond Xtampza ER?

Collegium Pharmaceutical is pursuing a strategy of diversification through strategic acquisitions of complementary pharmaceutical products and companies, aiming to build a broader portfolio across different therapeutic areas and reduce its dependence on any single product. Recent acquisitions have expanded its reach into areas like respiratory and migraine treatments.

Citations

[1] U.S. Food & Drug Administration. (2016, April 28). FDA approves Xtampza ER (oxycodone extended-release) tablets, for extended release oral use, C-II. [Press release]. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-for-patients-and-providers/fda-approves-xtampza-er-oxycodone-extended-release-tablets-extended-release-oral-use-c-ii

[2] U.S. Food & Drug Administration. (2015, July 2). FDA announces new steps to help curb the opioid crisis. [Press release]. Retrieved from https://www.fda.gov/news-events/press-announcements/fda-announces-new-steps-help-curb-opioid-crisis

[3] Schiavone, R. L. (2017). Abuse-deterrent opioid formulations: A guide for healthcare providers. Cleveland Clinic Journal of Medicine, 84(10), 779-786. doi:10.3949/ccjm.84a.17044

[4] Cicero, T. J., & Adams, M. C. (2019). Abuse-deterrent opioid formulations: Opportunities and challenges. The Journal of Pain, 20(12), 1377-1386. doi:10.1016/j.jpain.2019.04.004

[5] Collegium Pharmaceutical, Inc. (2024). Xtampza® ER (oxycodone extended-release) tablets, extended release oral use, C-II. Physician Prescribing Information. Retrieved from the manufacturer's website.

[6] Collegium Pharmaceutical, Inc. (2018). Form 10-K Annual Report for the fiscal year ended December 31, 2017. U.S. Securities and Exchange Commission.

[7] Collegium Pharmaceutical, Inc. (2019). Form 10-K Annual Report for the fiscal year ended December 31, 2018. U.S. Securities and Exchange Commission.

[8] Collegium Pharmaceutical, Inc. (2020). Form 10-K Annual Report for the fiscal year ended December 31, 2019. U.S. Securities and Exchange Commission.

[9] Collegium Pharmaceutical, Inc. (2021). Form 10-K Annual Report for the fiscal year ended December 31, 2020. U.S. Securities and Exchange Commission.

[10] Collegium Pharmaceutical, Inc. (2022). Form 10-K Annual Report for the fiscal year ended December 31, 2021. U.S. Securities and Exchange Commission.

[11] Collegium Pharmaceutical, Inc. (2023). Form 10-K Annual Report for the fiscal year ended December 31, 2022. U.S. Securities and Exchange Commission.

[12] Collegium Pharmaceutical, Inc. (2024). Form 10-K Annual Report for the fiscal year ended December 31, 2023. U.S. Securities and Exchange Commission.

[13] U.S. Patent and Trademark Office. (n.d.). Patent Search Database. Retrieved from https://www.uspto.gov/patents/search

[14] Collegium Pharmaceutical, Inc. (2023, February 14). Collegium Pharmaceutical Announces Definitive Agreement to Acquire BioDelivery Sciences. [Press release]. Retrieved from https://investors.collegiumpharma.com/news-releases/news-release-details/collegium-pharmaceutical-announces-definitive-agreement-acquire

[15] U.S. Food & Drug Administration. (n.d.). Drug Shortages. Retrieved from https://www.accessdata.fda.gov/scripts/drugshortages/ (Note: While not a direct citation for a specific drug's IP, this source highlights the dynamic regulatory landscape influencing pharmaceutical markets.)