XARTEMIS XR Drug Patent Profile

Which patents cover Xartemis Xr, and what generic alternatives are available?

Xartemis Xr is a drug marketed by Mallinckrodt Inc and is included in one NDA. There are twelve patents protecting this drug.

This drug has thirty-one patent family members in thirteen countries.

The generic ingredient in XARTEMIS XR is acetaminophen; oxycodone hydrochloride. There are sixty-six drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the acetaminophen; oxycodone hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Xartemis Xr

There have been three 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 is one tentative approval for the generic drug (acetaminophen; oxycodone hydrochloride), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for XARTEMIS XR

International Patents:	31
US Patents:	12
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	2
Patent Applications:	109
Drug Prices:	Drug price information for XARTEMIS XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XARTEMIS XR
DailyMed Link:	XARTEMIS XR at DailyMed

See drug prices for XARTEMIS XR

See drug sales revenues for XARTEMIS XR

Recent Clinical Trials for XARTEMIS XR

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

Sponsor	Phase
Lotus Clinical Research, LLC	Phase 4
Mallinckrodt	Phase 4

See all XARTEMIS XR clinical trials

US Patents and Regulatory Information for XARTEMIS XR

XARTEMIS XR is protected by twelve US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No			Y
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No			Y
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No			Y
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014		DISCN	Yes	No			Y

Expired US Patents for XARTEMIS XR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mallinckrodt Inc	XARTEMIS XR	acetaminophen; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204031-001	Mar 11, 2014

Premature patent expiration for: XARTEMIS XR

Expiration due to failure to pay maintenance fee

Patent Number	Tradename	Expiration Date
	XARTEMIS XR

International Patents for XARTEMIS XR

See the table below for patents covering XARTEMIS XR around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	256455
Australia	2001239893
Australia	3989301
Canada	2412671	COMPRIMES DESTINES A ACCROITRE LA RETENTION GASTRIQUE DE FORMES POSOLOGIQUES ORALES GONFLANTES A LIBERATION CONTROLEE (TABLET SHAPES TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORMS)
Germany	60101581
Denmark	1294363

Last updated: July 8, 2026

Market dynamics and financial trajectory for XARTEMIS XR (extended-release tramadol)

Executive summary: XARTEMIS XR (extended-release tramadol, NDA 021007) sits in the US extended-release opioid segment where market share is structurally constrained by safety-driven utilization shifts, generic pressure on older IR/ER tramadol brands, and payor controls on opioids. Public financial disclosures tied specifically to XARTEMIS XR are not available in the cited sources used here, but the drug’s commercial trajectory can be benchmarked through (1) FDA regulatory standing and genericization risk, (2) pricing and reimbursement dynamics typical for ER opioids, and (3) competitive headwinds from tramadol generics and alternative opioid and non-opioid analgesics.

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What is XARTEMIS XR and how is it positioned in the opioid market?

Featured snippet: XARTEMIS XR is an extended-release formulation of tramadol used for management of pain severe enough to require an around-the-clock opioid analgesic.

What active ingredient, dosage form, and indication define its demand profile?

• Active ingredient: Tramadol
• Dosage form: Extended-release (ER) oral tablets/capsule format (brand ER)
• Therapeutic area: Central nervous system analgesic in the opioid class
• Demand driver: Chronic and persistent pain management where prescribers prefer ER dosing to reduce dosing frequency versus immediate-release regimens.

How does ER tramadol compete versus other opioid choices?

In US practice, ER tramadol competes primarily against:

• Other ER opioids (e.g., ER oxycodone, morphine, hydrocodone ER where applicable by labeling and formularies)
• IR opioids for break-through pain plus ER “baseline” strategies
• Non-opioid and opioid-sparing options (NSAIDs, acetaminophen combinations, neuropathic pain agents, and, increasingly, non-opioid pain pathways).

Market dynamics for ER opioids are shaped less by clinical “superiority” and more by:

• Formulary placement
• Prior authorization and quantity limits
• PDMP monitoring and prescribing scrutiny
• Safety communications and risk management programs.

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What is the Orange Book status of XARTEMIS XR and what does it imply for revenue?

Featured snippet: XARTEMIS XR’s financial future is tightly coupled to US patent and exclusivity timelines for tramadol ER formulations and controlled-substance risk management requirements; once exclusivity and relevant patents expire, generic entry typically compresses brand revenue quickly.

How to map XARTEMIS XR to FDA submissions and exclusivity reality

XARTEMIS XR is an FDA-approved product, and the patent and exclusivity landscape is assessed via:

• FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)
• Associated patent listings for method, formulation, and use.

Commercial implication: For brands of older ER opioids, generic entry (or “authorized” generic strategies) commonly shifts the market to lower net prices and reduced brand unit volume unless brand differentiation persists via payer contracts or restricted generic eligibility.

Revenue exposure mechanism

Revenue typically erodes through:

1. Therapeutic switching to AB-rated generics
2. Payer-driven cost controls (step therapy, preferred generic lists)
3. Net price compression as wholesalers and PBMs push rebates to retain formulary position.

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When do XARTEMIS XR patents or exclusivity lose exclusivity, and what generic entry risks exist?

Featured snippet: Extended-release tramadol brands are generally exposed to genericization once formulation or method patents and exclusivity terms end; revenue compression usually follows generic launch and subsequent rebate and formulary re-contracting.

Patent-driven vs exclusivity-driven entry timing

Generic entry pathways are typically governed by:

• Patent expiry (listed in the Orange Book)
• Regulatory exclusivity (granted to the reference listed drug for certain submission types)
• Paragraph IV certifications on filing.

Generic entry risk assessment framework (market outcome)

For an ER opioid brand like XARTEMIS XR, generic entry risk translates into:

• Faster volume decline when multiple ANDA filers pursue manufacturing and scale
• Slower decline only if:
  • generics face manufacturing approvals delays,
  • payer rebates favor the brand under transitional contracting,
  • the brand retains unique patient access through specific formularies.

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How do Paragraph IV challenges against tramadol ER (and similarly positioned opioid brands) affect market share?

Featured snippet: Paragraph IV litigation is a common trigger for accelerated generic launch timing windows and payor backlash; settlements often set “launch at a date” frameworks that still lead to brand revenue step-down.

What settlement structures typically govern opioid generic launches

Industry-standard outcomes include:

• “Tied” launch dates based on settlement and patent carve-outs
• Co-promotion or authorized generic arrangements
• License agreements in which the brand receives a one-time payment or royalty in exchange for delayed entry.

Commercial effect on ER opioid brands

Once a generic launch occurs:

• brand net pricing drops
• prescribers shift to lowest-cost alternatives within class
• PMPM cost pressure forces PBMs into preferred positions for generics.

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What does XARTEMIS XR’s financial trajectory likely look like under generic pressure?

Featured snippet: For established ER opioid brands, financial trajectories typically follow a “steady-to-declining” pattern leading into generic eligibility, then a sharper net revenue and share decline after generic entry.

Typical financial trajectory pattern in ER opioids

A plausible brand financial model under genericization usually shows:

• Pre-generic window: stable revenue supported by formulary inclusion and brand awareness
• Near exclusivity/patent expiry: heightened price competition and rebate tightening
• Post-generic entry: rapid net revenue compression from AB-rated generics plus volume decline.

Where ER opioid brands can still maintain revenue

Revenue retention can persist if:

• brand is “preferred non-generic” through rebates
• generic adoption is slowed by stocking and switching friction
• brand has active REMS/Risk programs that prescribers and patients prefer.

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How strong is the patent estate for XARTEMIS XR, and what types of patents matter most for enforcement?

Featured snippet: For opioid ER brands, formulation, dosage regimen, and manufacturing process patents often dominate enforcement because they map directly to ANDA bioequivalence and labeling.

Patent categories that influence whether generics can be designed around

1. Formulation patents (matrix design, release profile, excipients)
2. Methods of manufacture (specific steps that may be harder to copy)
3. Use or method-of-treatment patents (less common than formulation for older products but still relevant).

Enforcement leverage in opioid ER markets

Patent strength matters in three ways:

• Likelihood of surviving Paragraph IV in district court
• Settlement attractiveness to the generic filer
• Ability to obtain an FDA “skinny label” workaround if claims are narrow.

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Which competitors and therapeutic substitutes drive XARTEMIS XR substitution?

Featured snippet: Substitution pressure comes from AB-rated tramadol ER generics and from alternative opioid and non-opioid analgesic classes that PBMs steer patients toward.

Competitive landscape inside tramadol ER

Main competitive forces:

• tramadol ER generic tablets/capsules (AB-rated)
• tramadol IR and other opioid ERs for dosing flexibility.

Cross-class substitution

PBM steering frequently shifts utilization to:

• non-opioid multimodal regimens
• ER opioid competitors with better formulary placement or lower net cost
• drugs with stronger managed-care contracting.

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What payer and regulatory dynamics shape demand for XARTEMIS XR?

Featured snippet: ER opioid utilization is managed by payers through prior authorization, quantity limits, and opioid-safety monitoring; these levers affect both volume and net pricing.

US regulatory and safety dynamics that affect prescribing

Key influences include:

• opioid risk mitigation measures and ongoing safety communications by regulators
• enforcement and monitoring intensity using PDMP and prescribing guidelines.

Payment dynamics

Payers typically impose:

• step edits (documented prior therapies)
• limits by dose or duration
• higher cost share or restricted coverage for non-preferred products.

Commercial effect: even when a brand is clinically acceptable, payer tools cap formulary upside.

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What manufacturing and supply-chain considerations affect market share for XARTEMIS XR?

Featured snippet: For ER opioids, supply continuity is crucial because ER switching and stocking interruptions directly increase prescriber friction and utilization losses.

What could create share volatility?

Share can fluctuate due to:

• manufacturing capacity constraints
• stability or packaging issues
• generic stock availability (which can accelerate brand declines when generics are in steady supply).

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Key takeaways

• XARTEMIS XR is an ER tramadol opioid brand exposed to structural market headwinds common to older ER opioids: safety scrutiny, payer controls, and genericization pressure.
• Its commercial trajectory is governed primarily by FDA status (Orange Book listing and patent/exclusivity timing) and litigation/settlement outcomes that determine generic launch windows.
• Under typical opioid-class economics, brand revenue trajectories move from stability to compression as generic entry approaches, then step-down following generic launches driven by PBM rebate economics and formulary switching.
• The strongest levers affecting near-to-mid-term financial performance are likely patent enforceability (formulation/manufacturing), Paragraph IV outcomes, and formulary contracting strength versus AB-rated tramadol ER generics and cross-class analgesic substitutes.

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FAQs

1) What drives net price decline for extended-release tramadol brands after generic entry?
AB-rated competition plus PBM rebate pressure and preferred formulary contracting typically force net price compression and higher formulary switching rates.

2) Do payer opioid controls reduce overall demand for ER opioids or only shift within-class?
Both; controls can reduce total opioid utilization and shift use toward preferred options within class and toward non-opioid regimens.

3) How do manufacturing approvals affect generic launch timing for tramadol ER?
ANDA approval schedules, scale-up readiness, and stability/CMC compliance determine whether generics launch promptly and consistently, which in turn dictates the speed of brand share loss.

4) What patent types are most relevant in opioid ER litigation?
Formulation (release profile and excipients), manufacturing methods, and select use claims, because they map directly to ANDA design-around feasibility and FDA labeling strategy.

5) What commercial impact follows an opioid generic settlement agreement?
Settlements often set a defined launch date or carve-outs that create step changes in brand volume and net pricing once generics enter.

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References

1. FDA. “Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.” U.S. Food and Drug Administration.
2. FDA. “Drugs@FDA.” U.S. Food and Drug Administration.
3. FDA. “Paragraph IV Certification and Patent Litigation (overview materials and related FDA resources).” U.S. Food and Drug Administration.
4. U.S. Code of Federal Regulations. 21 CFR Part 314 (New Drug Applications and Approval of ANDAs, including patent certification framework).