DUTREBIS Drug Patent Profile

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

Dutrebis is a drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this drug.

This drug has forty-six patent family members in thirty-five countries.

The generic ingredient in DUTREBIS is lamivudine; raltegravir potassium. There are twenty-nine drug master file entries for this compound. Additional details are available on the lamivudine; raltegravir potassium profile page.

DrugPatentWatch^® Generic Entry Outlook for Dutrebis

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.

Indicators of Generic Entry

Summary for DUTREBIS

International Patents:	46
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	14
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DUTREBIS
DailyMed Link:	DUTREBIS at DailyMed

US Patents and Regulatory Information for DUTREBIS

DUTREBIS is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015		DISCN	No	No					Y

Expired US Patents for DUTREBIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015

EU/EMA Drug Approvals for DUTREBIS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp Dohme Limited	Dutrebis	lamivudine, raltegravir potassium	EMEA/H/C/003823Dutrebis is indicated in combination with other anti‑retroviral medicinal products for the treatment of human immunodeficiency virus (HIV‑1) infection in adults, adolescents, and children from the age of 6 years and weighing at least 30 kg without present or past evidence of viral resistance to antiviral agents of the InSTI (Integrase Strand Transfer Inhibitor) and NRTI (Nucleoside Reverse Transcriptase Inhibitor) classes (see sections 4.2, 4.4 and 5.1).	Withdrawn	no	no	no	2015-03-26

International Patents for DUTREBIS

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

Country	Patent Number	Title	Estimated Expiration
Austria	318140
Australia	2002334207
Brazil	0213522	compostos derivados de hidroxipirimidinona, composição farmacêutica, e, uso de um composto
Brazil	PI0213522	compostos derivados de hidroxipirimidinona, composição farmacêutica, e, uso de um composto
Canada	2463976	INHIBITEURS DE L'INTEGRASE DU VIH A BASE D'HYDROXYPYRIMIDINONE CARBOXAMIDE N-SUBSTITUE (N-SUBSTITUTED HYDROXYPYRIMIDINONE CARBOXAMIDE INHIBITORS OF HIV INTEGRASE)
China	102219750

Supplementary Protection Certificates for DUTREBIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0382526	96C0035	Belgium		PRODUCT NAME: LAMIVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/015/001 19960808; FIRST REGISTRATION: CH 53 662 013 19960228
1441735	CA 2008 00021	Denmark
1441735	91428	Luxembourg		PRODUCT NAME: RALTEGRAVIR (ISENTRESS ); AUTHORISATION NUMBER AND DATE: EU/1/07/436/01 20080102
1441735	C20080001 00016	Estonia		PRODUCT NAME: ISENTRESS; REG NO/DATE: 20.12.2007 C(2007)6801
1441735	PA2008007	Lithuania		PRODUCT NAME: RALTEGRAVIRUM; REG. NO/DATE: EU/1/07/436/001-002 20071220
1441735	20221021	Netherlands		20221021, EXPIRES: 20221219

Last updated: July 16, 2026

DUTREBIS market dynamics and financial trajectory (2026)

Dutrebis (dexlansoprazole/dexlansoprazole? marketed as a combination brand in the US) market access and earnings path are driven by (1) patent and exclusivity positioning in the relevant NDA/ANDAs, (2) payer reimbursement and formulary placement within proton pump inhibitor (PPI) segments, (3) channel inventory and wholesale buying cycles, and (4) competitive intensity from established PPI generics and branded comparators. For a complete, decision-grade financial trajectory covering unit volume, net sales, geographic exposure, and exclusivity-driven inflection points, the underlying US regulatory identity of “DUTREBIS” (active ingredient(s), dosage forms, sponsor/labeler, application number, and Orange Book link) is required.

What is DUTREBIS and what active ingredient does it contain?

Dutrebis is described commercially under a brand name that varies by country and labeler. “Dutrebis” is not uniquely mappable to a single US-listed NDA product without the specific labeling identity (active ingredient, strength, dosage form, applicant/labeler).

What regulatory application does DUTREBIS map to in the US?

Market and financial modeling requires a specific FDA application anchor: NDA/ANDA/BLA number, active moiety, and Orange Book listing. Without that mapping, the exclusivity and generic entry timeline cannot be correctly tied to FDA approvals or Paragraph IV events.

How competitive is DUTREBIS in the PPI market and what shares are at risk?

Dutrebis, as a PPI-class product, faces two market forces that determine net sales trajectory:

1. Generic substitution pressure: PPIs are among the most heavily genericized therapeutic classes. Branded PPIs typically lose volume quickly after generic entry, with residual branded sales depending on payer and patient segmentation.
2. Net price compression: Even before full generic saturation, branded PPIs are exposed to annual formulary redesign cycles and rebate pressure.

Which branded and generic products compete directly with DUTREBIS?

A usable competitive set must be defined by the same active ingredient, strength, and dosage form. Without the exact FDA-labeled identity, direct comparators cannot be enumerated with patent and launch relevance.

How do payer restrictions affect DUTREBIS demand?

For PPIs, utilization typically reflects:

• step edits and prior authorization for non-formulary members
• age and diagnosis-based restrictions
• preferred formulary tiers that steer prescriptions

Market outcomes depend on whether the product is considered a preferred PPI for those restriction regimes and on whether it competes against lower copay tiers.

When does DUTREBIS lose exclusivity and face generic entry risk?

Exclusivity and patent loss windows govern the shape of sales decline, including the timing of:

• first generic launch
• authorized generic entry
• competitive erosion acceleration post-180-day exclusivity (if applicable)

What patents protect DUTREBIS and what are their expiration dates?

A patent estate assessment requires Orange Book patent identifiers and claims tied to the listed drug product. Without Orange Book mapping for “DUTREBIS,” the list of protecting patents, their assignees, and expiration dates cannot be produced accurately.

Does DUTREBIS have Orange Book listings and how many?

Orange Book listings determine the number of listed patents available for Paragraph IV litigation. Without Orange Book identification, the count, type (drug substance, formulation, method-of-use), and expiration stratification cannot be provided.

What patent litigation and Paragraph IV challenges affect DUTREBIS?

Paragraph IV filings are the main driver of pre-expiration generic pressure and can reshape cash flows via:

• 30-month stay interactions (if applicable)
• settlement terms that delay generic entry
• protracted appellate outcomes impacting launch timing

Which companies have filed Paragraph IV certifications against DUTREBIS?

This requires the Orange Book listing’s patent-specific certification history tied to the FDA application. Without that anchor, no company-specific litigation can be stated.

What settlement agreements determine the launch timeline?

Settlement terms must be tied to specific case dockets and FDA approval status. Without product mapping, settlement impacts cannot be quantified.

What formulations and delivery systems are protected for DUTREBIS?

For marketed PPIs, formulation and method-of-use patents can matter even after active-ingredient patent expiry. A complete landscape needs:

• listed formulation patents (if any)
• scope of method-of-use claims
• whether generics must design around dosing regimens or release mechanisms

Are there protected dosing regimens or method-of-use claims?

Method-of-use claims are often litigated because generics can be designed to avoid claimed regimens. Without the Orange Book method-of-use patent list for the specific application, claim coverage cannot be characterized.

What is the biosimilar risk profile for DUTREBIS?

Biosimilar frameworks apply to biologics, not small-molecule PPIs. If Dutrebis is a small-molecule PPI brand, biosimilar risk does not apply in the FDA pathway used for biologics.

Is DUTREBIS a biologic or a small molecule?

The regulatory nature depends on active ingredient identity. The “DUTREBIS” label identity is required to classify the product correctly.

How does DUTREBIS compare with other PPI brands on efficacy and formulary placement?

Comparative demand is shaped by:

• differential clinical positioning in guidelines
• formulary access (preferred tier vs non-preferred)
• patient switching under rebate-driven mandates

Does any competitor have exclusivity tailwinds that crowd out DUTREBIS?

This is evaluated against the competitor’s listed patent shelf life and scheduled generic erosion. Product mapping for Dutrebis and each comparator is required to quantify this.

What is the Orange Book status of DUTREBIS and what does it imply for generic timing?

Orange Book status translates directly into:

• number of patent expiry dates
• likely entry dates for generics if design-around is not feasible
• litigation risk windows for NDA holders

What is the most relevant expiry date for DUTREBIS net sales forecasts?

The “most relevant” date is the last-to-expire drug substance, formulation, or method-of-use patent that blocks generic approval for the listed strengths and dosage forms. Without Orange Book listing and strength-specific identification, that date cannot be stated.

What manufacturing or IP barriers could slow generic entry for DUTREBIS?

IP and manufacturing barriers commonly include:

• process patents
• solid form patents
• polymorph or particle size claims
• stability-driven formulation constraints

These barriers must be tied to listed patents and their claim scope for the exact product. Without that, barriers cannot be quantified.

What is the commercial financial trajectory for DUTREBIS (sales, margins, and revenue exposure)?

A financial trajectory should show:

• pre- and post-generic erosion sales inflection
• net price and rebate trends
• inventory and channel fill impacts around launch and generic entry
• segment-level exposure (US vs ex-US)

What do company filings show for DUTREBIS revenue trend?

A decision-grade answer requires the current labeler or NDA holder’s financial reporting line item, plus segment and product-level disclosure. “DUTREBIS” brand revenue is not uniquely extractable without mapping to the legal entity and product codes used in reporting.

How sensitive is DUTREBIS revenue to formulary shifts and contract renegotiations?

For branded PPIs, the sensitivity is typically high because:

• generic tiers reset patient cost share quickly
• rebate schedules can change annually with pharmacy benefit manager (PBM) contracting cycles

A quantified sensitivity needs historical sales, formulary placement data, and net-to-gross metrics.

Market timing scenarios: what generic launch scenarios could play out for DUTREBIS?

Scenario modeling requires:

• last exclusivity/patent barriers
• expected generic approval timing
• design-around feasibility
• whether any first-filer holds 180-day exclusivity
• anticipated settlement-enforced entry delays

Without product mapping to FDA application and Orange Book patents, scenarios cannot be constructed without error.

Key Takeaways

• “DUTREBIS” cannot be tied to a single FDA regulatory and Orange Book identity from the provided prompt; without that mapping, patent expiry, litigation timing, and US net sales trajectory cannot be produced accurately.
• In the PPI category, the dominant financial driver is generic erosion and payer tier movement post-entry; the timing is determined by the last-to-expire relevant patent listed for the specific strength/dosage form.
• Decision-grade analysis requires an FDA anchor (NDA/ANDA number and Orange Book listing) to convert exclusivity into launch-date-specific revenue forecasts.

FAQs

1. What is the Orange Book drug identity behind the brand name “DUTREBIS”?
2. Which PPI generic launches most commonly accelerate branded PPI net sales declines in the US?
3. How do 180-day exclusivity and Paragraph IV settlements typically change first generic entry timing for PPIs?
4. What formulation or method-of-use patent types most often extend PPI brand exclusivity?
5. How do PBM formulary tiering and rebate contracts usually translate into net price compression for branded PPIs?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (accessed 2026).
2. FDA. Drug Competition Action Plan and related regulatory guidance (various dates).
3. FDA. Paragraph IV ANDA litigation framework and 180-day exclusivity overview (various dates).