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 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 six 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:	24
Clinical Trials:	2
Patent Applications:	3,901
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
University of Alabama at Birmingham	Early Phase 1
Ajay Wasan, MD, Msc	Phase 4
Collegium Pharmaceutical, Inc.	Phase 4

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

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	208090-003	Apr 26, 2016	9,763,883
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016	10,525,053
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016	9,592,200
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-004	Apr 26, 2016	9,592,200
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016	8,840,928

International Patents for XTAMPZA ER

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004004693
European Patent Office	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)
Denmark	1765292
Poland	1765292

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

Introduction

Xtampza ER, an extended-release (ER) formulation of oxycodone, has been a significant player in the opioid market since its introduction in 2016. Developed by Collegium Pharmaceutical, this drug is designed with abuse-deterrent properties to mitigate the risks associated with opioid misuse. Here, we delve into the market dynamics and financial trajectory of Xtampza ER.

Market Position and Growth

Xtampza ER has demonstrated robust growth in the market. The drug's prescriptions increased 50-fold during the study period from its launch, indicating strong adoption by healthcare providers[1].

Prescription Trends

• The number of prescriptions for Xtampza ER has shown consistent growth. For instance, in the first half of 2021, Xtampza ER saw a 7% growth, which was the highest among all branded ER opioids[3].
• The drug's market share has continued to increase, with new prescribers and patients being added to its user base. As of 2021, Xtampza ER's unique prescribers had increased, and its new prescription (NBRx) share exceeded its total prescription (TRx) share[3].

Abuse-Deterrent Features

Xtampza ER is formulated using DETERx® technology, which incorporates microspheres of oxycodone myristate to limit the solubility of oxycodone in water. This design aims to discourage tampering and abuse.

Clinical Evidence

• Studies have shown that Xtampza ER maintains its pharmacokinetic (PK) profile even when manipulated, and it is less preferred when crushed and administered intranasally compared to immediate-release (IR) oxycodone[4].
• Data from the RADARS System indicates that cases of abuse, misuse, and diversion for Xtampza ER were infrequent and did not increase despite the significant rise in prescriptions[1].

Financial Performance

Collegium Pharmaceutical's financial reports provide insight into the financial trajectory of Xtampza ER.

Revenue Growth

• In the third quarter of 2024, Xtampza ER net revenue reached a record $49.5 million, representing a 24% year-over-year increase[2].
• The overall net revenue for Collegium Pharmaceutical in the third quarter of 2024 was $159.3 million, a 17% increase from the same period in 2023[2].

Operating Expenses and EBITDA

• Adjusted operating expenses for Collegium Pharmaceutical increased by 23% year-over-year in the third quarter of 2024, but the company maintained a strong adjusted EBITDA of $105.1 million, an 18% increase from the previous year[2].
• The company's cash balance as of September 30, 2024, was $120.0 million, although this was down from $310.5 million at the end of 2023[2].

Market Access and Coverage

Xtampza ER enjoys broad market access, which has been a key factor in its growth.

Commercial and Medicare Coverage

• As of 2021, Xtampza ER was covered by 84% of commercial plans and 57% of Medicare Part D plans, providing access to a significant portion of the insured population[3].
• The drug is also covered through exclusive and parity contracts for a substantial number of lives, enhancing its market reach[3].

Competitive Landscape

Xtampza ER operates in a competitive opioid market, but its abuse-deterrent features and strong market access have helped it stand out.

Comparison with Other Opioids

• When compared to other ER opioids, Xtampza ER has shown lower rates of abuse and misuse. For example, poison center exposures were greater for IR oxycodone and non-abuse-deterrent ER opioids than for Xtampza ER[1].
• The drug's unique formulation and lower abuse liability have positioned it favorably against competitors like OxyContin, Hysingla ER, and Embeda[1].

Clinical Efficacy

Xtampza ER has demonstrated significant clinical efficacy in managing moderate to severe chronic pain.

Clinical Trials

• In a 12-week clinical trial, Xtampza ER showed a significant reduction in average pain intensity compared to placebo, with a mean difference of 1.85 (P < 0.0001)[4].
• Patients were titrated to a stable and tolerated dose, and the drug maintained its efficacy throughout the trial period[4].

Future Outlook

Given its strong market position, financial performance, and clinical efficacy, Xtampza ER is poised for continued growth.

Patent Protection and Exclusivity

• Collegium Pharmaceutical has a strong patent position for Xtampza ER, with 19 Orange Book-listed patents extending through 2036. This provides a long commercial runway for the drug[3].

Financial Guidance

• The company has reaffirmed its full-year guidance, indicating confidence in the continued performance of Xtampza ER and other products in its portfolio[5].

Key Takeaways

• Strong Prescription Growth: Xtampza ER prescriptions have increased significantly since its launch.
• Abuse-Deterrent Features: The drug's formulation reduces the likelihood of abuse and misuse.
• Financial Performance: Xtampza ER has contributed to Collegium Pharmaceutical's record revenues and adjusted EBITDA.
• Market Access: Broad coverage by commercial and Medicare plans enhances its market reach.
• Clinical Efficacy: Xtampza ER has shown significant pain reduction in clinical trials.
• Future Outlook: Strong patent protection and financial guidance indicate a positive future trajectory.

FAQs

What is Xtampza ER, and how does it differ from other opioids?

Xtampza ER is an extended-release formulation of oxycodone designed with abuse-deterrent properties using DETERx® technology. This technology makes the drug less soluble in water, reducing the likelihood of tampering and abuse.

How has Xtampza ER performed financially?

In the third quarter of 2024, Xtampza ER net revenue reached a record $49.5 million, a 24% year-over-year increase. The overall net revenue for Collegium Pharmaceutical also saw a significant increase during this period.

What is the market access like for Xtampza ER?

Xtampza ER is covered by 84% of commercial plans and 57% of Medicare Part D plans, providing broad market access.

How effective is Xtampza ER in clinical trials?

Xtampza ER has shown significant pain reduction in clinical trials, with a mean difference of 1.85 in average pain intensity compared to placebo (P < 0.0001).

What is the future outlook for Xtampza ER?

With strong patent protection through 2036 and continued financial growth, Xtampza ER is poised for further market dominance.

How does Xtampza ER compare to other abuse-deterrent opioids?

Xtampza ER has lower rates of abuse and misuse compared to other ER opioids and immediate-release oxycodone, making it a preferred option for managing chronic pain while minimizing abuse risks.

Sources

1. Postmarketing Analysis of Misuse, Abuse, and Diversion of Xtampza ER - Academic.oup.com
2. Collegium Reports Record Third Quarter 2024 Financial Results - IR.Collegiumpharma.com
3. Collegium Pharmaceutical, Inc. Corporate Overview - IR.Collegiumpharma.com
4. New Drug Review, Xtampza ER Drug Monograph - Mass.gov
5. Collegium Reports First Quarter 2023 Financial Results - IR.Collegiumpharma.com