LINAGLIPTIN Drug Patent Profile

When do Linagliptin patents expire, and when can generic versions of Linagliptin launch?

Linagliptin is a drug marketed by Aurobindo Pharma Ltd, Dr Reddys, Invagen Pharms, MSN, Mylan, Sunshine, and Zydus Pharms. and is included in eleven NDAs.

The generic ingredient in LINAGLIPTIN 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 Linagliptin

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

Summary for LINAGLIPTIN

US Patents:	0
Applicants:	7
NDAs:	11
Raw Ingredient (Bulk) Api Vendors:	83
Clinical Trials:	151
Patent Applications:	3,501
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LINAGLIPTIN
DailyMed Link:	LINAGLIPTIN at DailyMed

Recent Clinical Trials for LINAGLIPTIN

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

Sponsor	Phase
AJU Pharm Co., Ltd.	PHASE1
Xiangyang No.1 People's Hospital	PHASE4
Taihe Hospital	PHASE4

See all LINAGLIPTIN clinical trials

Medical Subject Heading (MeSH) Categories for LINAGLIPTIN

Dipeptidyl-Peptidase IV Inhibitors

Hypoglycemic Agents

Incretins

Anatomical Therapeutic Chemical (ATC) Classes for LINAGLIPTIN

A10BH	Dipeptidyl peptidase 4 (DPP-4) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

Paragraph IV (Patent) Challenges for LINAGLIPTIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TRADJENTA	Tablets	linagliptin	5 mg	201280	11	2015-05-04

US Patents and Regulatory Information for LINAGLIPTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	LINAGLIPTIN	linagliptin	TABLET;ORAL	208415-001	Nov 3, 2025	AB	RX	No	No
Zydus Pharms	LINAGLIPTIN AND METFORMIN HYDROCHLORIDE	linagliptin; metformin hydrochloride	TABLET;ORAL	208449-001	Mar 30, 2023	AB	RX	No	No
Zydus Pharms	LINAGLIPTIN	linagliptin	TABLET;ORAL	208448-001	Mar 30, 2023	AB	RX	No	No
Msn	LINAGLIPTIN	linagliptin	TABLET;ORAL	208457-001	Nov 3, 2025	AB	RX	No	No

EU/EMA Drug Approvals for LINAGLIPTIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Trajenta	linagliptin	EMEA/H/C/002110Trajenta is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults:as monotherapyin patients inadequately controlled by diet and exercise alone and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.as combination therapyin combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.in combination with insulin with or without metformin, when this regimen alone, with diet and exercise, does not provide adequate glycaemic control.	Authorised	no	no	no	2011-08-23

Market Dynamics and Financial Trajectory for LINAGLIPTIN

Last updated: December 11, 2025

Executive Summary

Linagliptin, branded as Tradjenta in the United States and as a key component of combination therapies globally, is a dipeptidyl peptidase-4 (DPP-4) inhibitor used primarily for managing type 2 diabetes mellitus (T2DM). Since its FDA approval in 2011, linagliptin has experienced steady commercial growth. Projected expansion hinges on evolving diabetes prevalence, competitive innovation, regulatory trends, and geographic expansion. As a high-value, relatively differentiated DPP-4 inhibitor, linagliptin's market position is anchored by its unique pharmacokinetic profile—primarily its non-renal clearance—offering benefits to patients with renal impairment.

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What Are the Key Market Drivers and Trends for Linagliptin?

Global Diabetes Epidemic as Growth Catalyst

• The International Diabetes Federation (IDF) estimates 537 million adults diagnosed with diabetes globally in 2021; projected to reach 643 million by 2030, and 783 million by 2045 [1].

• Linagliptin’s primary indication aligns with the management of T2DM, positioning it as a key therapeutic in an expanding market.

Competitive Position Against Other DPP-4 Inhibitors

Drug Name	Key Advantages	Market Share in 2022	Approval Shelf Life
Linagliptin	No renal dose adjustment, once-daily dosing	~25% (Global)	2011 (FDA)
Sitagliptin	Established, high familiarity	~35%	2006
Saxagliptin	Additional cardiovascular benefits	~15%	2009
Alogliptin	Favorable renal profile	~5%	2013

• Linagliptin’s pharmacokinetics confer advantages for patients with renal impairment, a significant subset in diabetes demographics.

Regulatory and Policy Influences

• Cardiovascular outcomes trials (CVOTs): Need to demonstrate CV safety (e.g., TECOS for sitagliptin, CARMELINA for linagliptin) impact prescribing trends and reimbursement strategies.

• Pricing regulations and access policies influence market penetration, especially in emerging markets with price-sensitive healthcare systems.

Geographical Expansion and Market Penetration

• North America: Mature market, high adoption rate driven by established healthcare infrastructure.

• Europe: Growing reputation, supported by EMA approvals and guidelines.

• Asia-Pacific: Rapid growth driven by soaring T2DM prevalence, rising healthcare expenditure, and governmental initiatives.

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Financial Trajectory: Revenue, Market Share, and Forecasts

Historical Revenue Milestones

Year	Global Revenue (USD millions)	Notes
2012	~$300	Early launch period, initial adoption
2016	~$800	Increased global penetration, portfolio expansion
2020	~$1,100	Growth driven by Asian markets and combination therapies
2022	~$1,250	Maturation in established markets, new formulations

(All figures approximate, derived from IQVIA data and industry analyst reports.)

Forecast: 2023–2028

Year	Projected Revenue (USD millions)	Compound Annual Growth Rate (CAGR)
2023	~$1,350	8%
2024	~$1,460	8.2%
2025	~$1,580	8.3%
2026	~$1,710	8.2%
2027	~$1,850	8.2%
2028	~$2,000	8%

Forecast assumptions include increased adoption of fixed-dose combinations, improved pricing strategies, and expanded access in emerging markets.

Key Revenue Growth Factors

• Expansion of indications: Use in combination treatments increases average revenue per patient.

• Introduction of biosimilars and generics: Slightly pressure pricing but expand access.

• Enhanced formulary inclusion: Payers adding linagliptin as preferred agent.

• Emerging markets: Account for nearly 40% of future growth, driven by demographic and urbanization trends.

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Market Challenges and Risks

Challenge	Impact	Mitigation Strategy
Competitive DPP-4 inhibitors	Market share erosion	Innovation, differentiation
Patent expiries (e.g., 2026 for Linagliptin in US)	Price erosion	Diversification into combination therapies, lifecycle extensions
Regulatory environment shifts	Approval delays or restrictions	Active engagement with regulators
Price controls in emerging markets	Reduced margins	Cost minimization, local manufacturing

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Comparison with Major Competitors

Feature	Linagliptin	Sitagliptin	Saxagliptin	Alogliptin
Approval Year	2011	2006	2009	2013
Pharmacokinetics	Non-renal clearance	Renal dose adjustment	Renal clearance	Renal adjustment
CVOT Data	CARMELINA, CAROLINA	TECOS	SAVOR-TIMI 53	EXAMINE
Special Benefits	No dose adjustment in renal impairment	Established history	CV benefits	Fewer data, targeted for renal impairment

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Future Growth Opportunities

• Combination therapies: Fixed-dose combinations with metformin, SGLT2 inhibitors, and GLP-1 receptor agonists.

• Novel formulations: Extended-release versions, injectable delivery systems.

• Personalized medicine: Biomarker-driven therapy to optimize response.

• Geographical expansion: Focused efforts in Asia-Pacific, Latin America, and Africa.

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Regulatory and Patent Landscape

Key Regulatory Milestones

Date	Agency	Landmark Decision	Notes
2011	FDA	Approval for monotherapy and combination	First DPP-4 inhibitor with renal benefits
2012	EMA	Approval	Similar indications

Patent Lifespan and Generics

Patent Expiry	Jurisdiction	Notes
2026	U.S.	Patent cliff approaches, potential generics
2024	EU	Patent expiry in some European countries

• Patent expiry could impact revenues but can be mitigated through lifecycle management strategies.

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Key Takeaways

• Market expansion remains robust, driven by rising global diabetes prevalence, especially in emerging markets.

• Linagliptin’s pharmacokinetic profile offers competitive advantage in patients with renal impairment, a key segment.

• Financial growth is steady, with projections exceeding $2 billion global sales by 2028, assuming continued market acceptance and portfolio expansion.

• Patent expiries pose a potential revenue risk; strategic focus on combination therapies and lifecycle innovations are critical.

• Regulatory trends favor cardiovascular safety and personalized approaches, shaping future development pathways.

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FAQs

Q1: How does linagliptin compare in efficacy to other DPP-4 inhibitors?
A1: Clinical trials (CARMELINA, CAROLINA) demonstrate comparable glucose-lowering efficacy and safety profiles among DPP-4 inhibitors, with linagliptin showing added advantages in patients with renal impairment.

Q2: What are the patent expiry dates, and how will they influence the market?
A2: The primary patent for linagliptin is expected to expire around 2026 in the U.S. and 2024 in some jurisdictions. This may lead to generic entry, exerting pricing pressure but also providing opportunities for market share in cost-sensitive regions.

Q3: What role do combination therapies play in linagliptin’s future?
A3: Significant, as fixed-dose combinations with metformin, SGLT2 inhibitors, and GLP-1 receptor agonists can enhance adherence, broaden indications, and increase sales.

Q4: How is the regulatory landscape evolving for diabetes drugs like linagliptin?
A4: Emphasis on cardiovascular safety, real-world evidence, and personalized medicine is shaping policy, with recent CVOTs influencing labeling and reimbursement decisions.

Q5: Which regions present the highest growth opportunities for linagliptin?
A5: Asia-Pacific dominates growth prospects with high T2DM prevalence and expanding healthcare infrastructure, followed by Latin America and Africa where access barriers are decreasing.

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References

[1] IDF Diabetes Atlas, 10th Edition, 2021.
[2] IQVIA Reports, 2022.
[3] U.S. Food and Drug Administration (FDA). Tradjenta (linagliptin) approval documents, 2011.
[4] European Medicines Agency (EMA). Linagliptin review summary, 2011.
[5] ClinicalTrials.gov. CARMELINA and CAROLINA trials, 2017-2020.