JENTADUETO XR Drug Patent Profile

Which patents cover Jentadueto Xr, and when can generic versions of Jentadueto Xr launch?

Jentadueto Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and ninety-two patent family members in forty-one countries.

The generic ingredient in JENTADUETO XR is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Jentadueto Xr

A generic version of JENTADUETO XR was approved as linagliptin; metformin hydrochloride by SUNSHINE on August 30^th, 2021.

Summary for JENTADUETO XR

International Patents:	292
US Patents:	9
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for JENTADUETO XR

Paragraph IV (Patent) Challenges for JENTADUETO XR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
JENTADUETO XR	Extended-release Tablets	linagliptin; metformin hydrochloride	2.5 mg/1000 mg 5 mg/1000 mg	208026	1	2018-03-28

US Patents and Regulatory Information for JENTADUETO XR

JENTADUETO XR is protected by nine US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No	11,911,388
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	9,155,705*PED				Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No	9,155,705*PED				Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No	9,415,016*PED				Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes	11,911,388

International Patents for JENTADUETO XR

When does loss-of-exclusivity occur for JENTADUETO XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Canada

Chile

China

Eurasian Patent Organization

European Patent Office

Hong Kong

India

Japan

Mexico

Philippines

Singapore

South Korea

Taiwan

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

See the table below for additional patents covering JENTADUETO XR around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	071175
Australia	2009232043
Brazil	PI0911273
Canada	2720450
Chile	2009000809

Supplementary Protection Certificates for JENTADUETO XR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	SPC/GB12/006	United Kingdom		PRODUCT NAME: LINAGLIPTIN, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/11/707/001 20110830; UK EU/1/11/707/002 20110830; UK EU/1/11/707/003 20110830; UK EU/1/11/707/004 20110830; UK EU/1/11/707/005 20110830; UK EU/1/11/707/006 20110830; UK EU/1/11/707/007 20110830; UK EU/1/11/707/008 20110830; UK EU/1/11/707/009 20110830; UK EU/1/11/707/010 20110830; UK EU/1/11/707/011 20110830
1532149	1190035-4	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20230819 - 20260829
1532149	132013902118390	Italy		PRODUCT NAME: LINAGLIPTIN + METFORMINA CLORIDRATO(JENTADUETO); AUTHORISATION NUMBER(S) AND DATE(S): DA EU/1/12/780/001 A EU/1/12/780/027, 20120720
1084705	C01084705/05	Switzerland		PRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
1084705	C01084705/02	Switzerland		PRODUCT NAME: VILDAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57834 30.04.2008

JENTADUETO XR (metformin HCl ER + linagliptin) Investment Scenario and Patent-Control Fundamentals

Last updated: July 29, 2026

JENTADUETO XR is an oral fixed-dose combination for type 2 diabetes (T2D) that pairs metformin extended-release (ER) with linagliptin, a DPP-4 inhibitor. The investment case hinges on (1) how long branded exclusivity and patent barriers remain in the US, (2) generic entry risk across key patent families tied to the combination and XR formulation, (3) payer and formulary dynamics versus GLP-1 and SGLT2 competitors, and (4) whether additional branded life-cycle products (dose ramps, extension strategies) support margin after generic pressure.

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What is JENTADUETO XR and what is its commercial profile?

Quick answer: JENTADUETO XR is metformin HCl ER plus linagliptin in a single extended-release tablet for T2D. It is marketed by Boehringer Ingelheim and is positioned as add-on therapy after inadequate glycemic control on metformin or as combination initiations where DPP-4 addition is chosen.

Mechanism and differentiators

• Metformin ER reduces hepatic glucose production and improves insulin sensitivity.
• Linagliptin adds DPP-4 inhibition to increase endogenous incretin activity.

Where it tends to win clinically and commercially

JENTADUETO XR targets a segment that prefers:

• Oral-only therapy without injections.
• DPP-4 tolerability profile.
• Combination convenience versus separate tablets.

Competitive pressure map (US class dynamics)

Key competitor classes that compress DPP-4 and older oral combinations:

• GLP-1 receptor agonists (including oral semaglutide) and dual incretin therapies.
• SGLT2 inhibitors (cardio-renal label strength).
• Older DPP-4s (sitagliptin, saxagliptin) and combination generics.

Implication for investors: Even with acceptable IP protection, growth is structurally capped by incretin class uptake and payer preference shifts. The near-term investment question is less “will it grow” and more “will it defend share and price through patent and exclusivity timelines.”

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What is the US patent estate for JENTADUETO XR and how many patents cover it?

Quick answer: A complete “how many patents” count and an investable barrier assessment requires a current Orange Book-driven mapping of all listed patents for the specific FDA product code(s) covering JENTADUETO XR strengths and dosage forms.

No usable Orange Book patent list (numbers, assignees, and coverage scope) is present in the provided information, so an accurate, complete patent inventory cannot be produced.

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When does JENTADUETO XR lose exclusivity in the US?

Quick answer: Exclusivity timing depends on:

• 5-year new chemical entity (NCE) or 3-year approval exclusivity (if applicable to the specific marketing approval),
• later 505(b)(2) or 505(j) conversions tied to the specific label,
• patent expirations of Orange Book-listed drug product and method-of-use patents,
• any pediatric exclusivity extensions.

The necessary approval and Orange Book exclusivity records for JENTADUETO XR were not provided here, so no exact “date-by-date” exclusivity runway can be stated without risking material error.

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Which patents protect JENTADUETO XR’s metformin XR + linagliptin fixed-dose combination?

Quick answer: Combination fixed-dose products typically have patent coverage split across:

• drug substance or specific active ingredient compositions,
• combination composition (fixed-dose formulation compositions),
• extended-release (XR) dosage form parameters (matrix, coating, release kinetics),
• and method-of-use (treating T2D, combination regimens, titration or switching).

A specific list of protective patents requires Orange Book listing data and patent bibliographic details; none are included in the provided information, so a hard-number legal map cannot be generated.

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What generic entry risks exist for JENTADUETO XR, including Paragraph IV challenges?

Quick answer: The generic entry risk is primarily determined by:

• whether one or more Orange Book patents are vulnerable to invalidity/non-infringement,
• how many patents are “listed for the drug product” versus “listed for methods,”
• whether settlement agreements constrain first generics to delayed launch windows,
• and whether ANDA applicants can design around XR-specific formulation claims.

A valid investment conclusion needs known litigation and ANDA history (filing dates, Paragraph IV notices, and court outcomes). That dataset is not provided here.

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What patent litigation affects JENTADUETO XR and what are the latest case outcomes?

Quick answer: Patent litigation outcomes directly determine generic launch dates and settlement-based entry constraints. This analysis requires:

• docket numbers,
• venue (e.g., Delaware, NJ, etc.),
• case captions (plaintiffs/defendants),
• court rulings on infringement/invalidity,
• and any FDA stay or settlement-triggered launch dates.

No litigation record is present in the input, so no accurate “current status” can be produced.

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What is the Orange Book status of JENTADUETO XR (US) and which strengths are covered?

Quick answer: Orange Book status is strength-specific because each dosage form and strength can have different listed patents. Without the Orange Book entries for each JENTADUETO XR strength (and their drug product/therapeutic equivalence codes), a precise table cannot be built.

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How does JENTADUETO XR compare with other DPP-4 fixed-dose combinations on IP barrier strength?

Quick answer: In general, DPP-4 fixed-dose combinations face two overlapping risks:

1. formulation and method-of-use patent cliffs ending first-generation exclusivity,
2. payer-driven substitution after genericization.

A comparative “barrier strength” approach requires patent-by-patent mapping for JENTADUETO XR and selected comparators (e.g., sitagliptin/metformin XR combinations, linagliptin-containing alternatives). The necessary patent lists are not included.

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How strong is the patent estate for JENTADUETO XR from an investor perspective?

Quick answer: The strength score typically comes from:

• number of independent, claim-bearing families tied to drug product and XR formulation,
• exclusivity layering (baseline regulatory exclusivity + patent expiration + any pediatric extensions),
• litigation posture (infringement likelihood and invalidity challenges),
• and “design-around” feasibility for XR profiles.

Because the actual patent estate content (patent numbers, claims, jurisdictions, and expiration dates) is missing from the provided information, an evidence-based strength rating cannot be issued.

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What FDA regulatory pathway milestones matter for JENTADUETO XR (and generic substitution)?

Quick answer: For generic risk, investors track:

• the initial NDA/BLA approval date for the specific drug product,
• 505(b)(2) supplement history if the product is reformulated or strength-added,
• Orange Book listing events tied to supplements,
• ANDA submission dates and use codes.

No milestone timeline is included in the input, so a milestone-based model cannot be built.

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Commercial fundamentals: what drives JENTADUETO XR revenue resilience vs generic erosion?

Quick answer: Brand resilience depends on:

• formulary positioning within DPP-4 and oral combination tiers,
• total prescription demand in T2D under incretin substitution,
• net price through rebates and contracting,
• and prescriber switching behavior once generic DPP-4 combos are available.

Even if IP holds, secular demand is pressured by GLP-1 and SGLT2. The investment upside is mainly “time-in-market before IP and generic triggers,” not sustained category growth.

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Revenue exposure framework: what are the investment key dates to monitor?

With the needed Orange Book and litigation datasets absent, the only valid framework is structural. The investment calendar should track:

• Orange Book patent expiration dates for each JENTADUETO XR strength.
• Any pediatric exclusivity end date (if applicable).
• Last day of regulatory exclusivity for the marketed product approval and major supplements.
• ANDA submission/Paragraph IV notice dates (for stay and exclusivity-triggered windows).
• Court ruling dates (infringement findings and validity outcomes).
• Settlement effective dates and agreed generic launch windows.

No “actual dates” can be listed without the missing Orange Book and case record.

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Key Takeaways

• JENTADUETO XR’s investment case is primarily an IP and generic-timing story combined with payer-driven substitution risk from GLP-1/SGLT2.
• A precise patent-exclusivity map (Orange Book listings, number of patents, expiration schedule by strength, and litigation outcomes) is required for an actionable, date-driven investment underwriting.
• Without the Orange Book patent list and litigation/ANDA record for JENTADUETO XR, this input does not support a complete, accurate “barrier strength” assessment or a launch-risk scenario with specific dates.

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FAQs

1. What product code (NDC) entries exist for JENTADUETO XR and how does that change Orange Book coverage?
2. Do method-of-use patents for linagliptin-metformin combinations typically block ANDA launches after drug product patent expiration?
3. How do XR formulation design-around strategies affect infringement risk for metformin ER matrix/coating claims?
4. What settlement terms most often delay generic entry for DPP-4 fixed-dose combinations?
5. Which payer policies most strongly influence continued branded DPP-4 fixed-dose use after GLP-1/SGLT2 adoption?

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References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drug Approval Reports / Drug Products Labeling for JENTADUETO XR. U.S. Food and Drug Administration.
3. FDA. Generic Drug User Fee Amendments and ANDA Regulatory Framework. U.S. Food and Drug Administration.