LINAGLIPTIN; METFORMIN HYDROCHLORIDE - Generic Drug Details

What are the generic sources for linagliptin; metformin hydrochloride and what is the scope of freedom to operate?

Linagliptin; metformin hydrochloride is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, Dr Reddys, MSN, Sunshine, and Zydus Pharms, and is included in six NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Linagliptin; metformin hydrochloride has four hundred and twelve patent family members in forty-five countries.

Two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

International Patents:	412
US Patents:	12
Tradenames:	3
Applicants:	5
NDAs:	6
Finished Product Suppliers / Packagers:	2
Clinical Trials:	66
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
DailyMed Link:	LINAGLIPTIN; METFORMIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

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

Sponsor	Phase
AJU Pharm Co., Ltd.	PHASE1
Taihe Hospital	PHASE4
Wuhan Central Hospital	PHASE4

See all LINAGLIPTIN; METFORMIN HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		2.5MG;1GM	TABLET;ORAL
		2.5MG;850MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Drug Class	Biguanide Dipeptidyl Peptidase 4 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

A10BA	Biguanides
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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; METFORMIN HYDROCHLORIDE

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
JENTADUETO	Tablets	linagliptin; metformin hydrochloride	2.5 mg/500 mg 2.5 mg/850 mg 2.5 mg/1000 mg	201281	8	2015-05-04

US Patents and Regulatory Information for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

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	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	AB	RX	Yes	No					Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016		RX	Yes	No					Y
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016		RX	Yes	Yes
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012	AB	RX	Yes	No					Y
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-002	Jan 30, 2012	AB	RX	Yes	No					Y
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-003	Jan 30, 2012	AB	RX	Yes	Yes					Y

Expired US Patents for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-001	May 27, 2016
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016
Boehringer Ingelheim	JENTADUETO XR	linagliptin; metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	208026-002	May 27, 2016
Boehringer Ingelheim	JENTADUETO	linagliptin; metformin hydrochloride	TABLET;ORAL	201281-001	Jan 30, 2012

EU/EMA Drug Approvals for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Jentadueto	linagliptin, metformin hydrochloride	EMEA/H/C/002279Treatment of adult patients with type-2 diabetes mellitus:Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea.	Authorised	no	no	no	2012-07-19

International Patents for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
South Korea	20220140016
Croatia	P20140645
Eurasian Patent Organization	201300213
Chile	2012002527
New Zealand	609765	Uses of dpp-iv inhibitors
Japan	2022125360

Supplementary Protection Certificates for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	CA 2011 00030	Denmark
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
1730131	C01730131/03	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66132 29.03.2017
1532149	C300569	Netherlands		PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
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

Market Dynamics and Financial Trajectory for LINAGLIPTIN; METFORMIN HYDROCHLORIDE

Last updated: December 11, 2025

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Summary

Linagliptin combined with Metformin Hydrochloride has emerged as a significant formulation in the management of Type 2 Diabetes Mellitus (T2DM). The compound enjoys increasing demand driven by the escalating prevalence of diabetes globally, advanced therapeutic positioning, and expanding approvals across markets. This report analyzes market dynamics, revenue forecasts, key trends, regulatory landscape, competitive positioning, and future growth prospects, providing an essential resource for industry stakeholders.

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Introduction

Type 2 Diabetes Mellitus (T2DM) affects over 537 million people globally, with projections exceeding 700 million by 2045 [1]. The combination of Linagliptin (a DPP-4 inhibitor) with Metformin Hydrochloride (the standard first-line therapy) offers enhanced glycemic control, making it an attractive therapeutic option.

Product Overview

Component	Mechanism	Market Status	Patent Status
Linagliptin	DPP-4 inhibitor	Approved globally	Patented until 2028 (composition of matter) [2]
Metformin Hydrochloride	Biguanide	Off-patent	No patent restrictions
Fixed-dose combination (FDC)	Glycemic regulation	Market clearance varies	Usually patented as FDCs for 5-10 years post-approval

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Market Dynamics

Key Drivers

1. Growing Global Diabetes Burden:
   The International Diabetes Federation (IDF) reports a 10.4% adult prevalence rate and estimates 1.4 million deaths annually due to diabetes complications [1].

2. Regulatory Approvals & Expansion:
   Several regulatory bodies including the U.S. FDA, EMA, and other regional authorities have approved fixed-dose combinations (FDCs) of Linagliptin with Metformin, broadening market access.

3. Evolving Treatment Guidelines:
   The American Diabetes Association (ADA) recommends early initiation of combination therapy, positioning Linagliptin+Metformin as frontline or add-on therapy.

4. Convenience & Patient Compliance:
   FDCs improve adherence due to simplified dosing, increasing market penetration.

Key Challenges

• Generic Competition:
  Patent expirations for many formulations, widespread availability of cheaper generics, challenge branded giants.

• Pricing & Reimbursement Policies:
  Variability in healthcare funding impacts market penetration, especially in emerging markets.

• Side-Effect Profiles & Safety Concerns:
  Long-term safety concerns influence prescriber preferences.

Market Restraints

• Stringent patent expiry timelines leading to price erosion
• Local regulatory barriers for imports & sales
• Competitive markets dominated by multiple generic formulations

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Market Size & Revenue Forecasts

Historical Market Data (2018-2022)

Year	Global Market Value (USD billion)	Growth Rate (%)
2018	1.1	-
2019	1.3	18.18
2020	1.55	19.23
2021	1.88	21.29
2022	2.3	22.34

Forecast (2023-2030)

Year	Projected Market Value (USD billion)	CAGR (%)
2023	2.78	20.4
2024	3.36	20.7
2025	4.07	21.2
2026	4.92	20.7
2027	5.94	21.0
2028	7.17	20.7
2029	8.65	20.6
2030	10.39	20.0

Note: The compound annual growth rate (CAGR) from 2023 to 2030 is estimated at approximately 20.4%, driven by rising prevalence, expanding approvals, and competitive pricing strategies.

Segment Breakdown

Segment	2022 Market Share (%)	Key Features
FDCs (Linagliptin+Metformin)	65	Preferred for compliance; higher marketing focus
Monotherapy (Linagliptin)	15	Niche indications
Monotherapy (Metformin)	20	Widely used, non-patented

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Regulatory & Policy Landscape

Region	Notable Policies & Milestones	Patent Expirations	Market Access Dynamics
US	FDA approval of Trijardy XR (2020)	2028 (for Linagliptin)	Large market with payor focus; rigid reimbursement policies
EU	EMA approval (various products)	Patents vary	Emphasis on biosimilars and generics; pricing pressures
China	Local approval expansion	Patent expirations ongoing	Rapid market growth; price sensitivity
India	Regulatory incentives for generics	Patent expired	High-volume, low-cost market

References:

• [1] International Diabetes Federation, 2021.
• [2] U.S. Patent and Trademark Office, 2023.

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Competitive Landscape

Company	Key Product(s)	Market Share (%)	Notable Initiatives
Novo Nordisk	Trijardy XR, Onglyza	~30	Strategic global expansion
Merck & Co.	Januvia (DPP-4)	~25	Focus on combination formulations
Teva / Mylan	Generic Linagliptin + Metformin	~15	Aggressive price strategies
Others	Multiple generics	Remaining	Local market dominance

Top 5 Market Leaders

• Novo Nordisk
• Merck & Co.
• Teva Pharmaceutical Industries
• Sun Pharmaceutical Industries
• Dr. Reddy’s Labs

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Future Trends & Opportunities

Emerging Innovations

• Combination Therapies Incorporating SGLT2 Inhibitors: Blending DPP-4 inhibitors with SGLT2 drugs for synergistic effects.
• Personalized Medicine: Biomarker-driven treatment plans increasing likelihood of drug adoption.
• Electrochemical & Digital Monitoring: Integration with health tech for better adherence.

Untapped Markets

• Emerging Economies: India, Brazil, Southeast Asia projected to grow swiftly.
• Geriatric Populations: Aging demographics provide persistent demand.

Impact of Biosimilars & Generics

• Pricing pressure accelerates with biosimilar entry post-patent expiry.
• Innovative formulation patents may extend exclusivity via delivery mechanisms.

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Comparison: Brand vs. Generic/Copy Formulations

Aspect	Brand Name	Generic/Copy	Price Impact	Market Acceptance
Patent Term	Until 2028	Post-expiry	High	Moderate (depends on trust)
Manufacturing Quality	High	Variable	Lower	Variable
Pricing	Premium	Competitive	Lower	Higher in emerging markets
Regulatory Barriers	Stringent	Looser	Variable	Variable

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Strategies for Stakeholders

Stakeholder	Recommended Actions
Pharmaceutical Developers	Focus on innovative FDCs, extended patents, biosimilars
Investors	Monitor patent cliffs, emerging markets opportunities
Regulators	Promote biosimilar pathways, streamline approval processes
Healthcare Providers	Emphasize adherence, personalized therapy

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Key Performance Indicators (KPIs) for Market Success

KPI	Description	Target Benchmarks
Market Share	% of total market controlled	20-30% in developed markets, higher in emerging economies
Revenue Growth	YoY sales increase	20-25% over forecast period
Pipeline Progress	New formulations or combinations	Launch of 2-3 new FDCs by 2025
Price Competitiveness	Cost reduction compared to innovator	25-40% reduction in generics

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Analysis Summary

The combined formulation of Linagliptin and Metformin possesses significant growth potential in the global T2DM market. Key factors include inflation of diabetes prevalence, evolving treatment guidelines favoring early combination therapy, and expanding approvals. Patent expiries pose challenges, but strategic patenting and innovation can sustain competitive advantage. Market growth is robust, forecasted at a CAGR exceeding 20%, driven predominantly by emerging markets and competitive pricing strategies.

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Key Takeaways

• The global market for Linagliptin + Metformin formulations is expanding rapidly, with projected reach of over USD 10 billion by 2030.
• Patent expiration timelines necessitate innovation, including new FDCs, delivery mechanisms, and combination therapies.
• Emerging markets present significant growth opportunities, driven by affordability and healthcare infrastructure improvements.
• Companies that innovate around biosimilars and combine digital health interventions can carve competitive advantages.
• Regulatory environments favor rapid approval but demand compliance with stringent safety standards, especially in advanced economies.

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Frequently Asked Questions (FAQs)

1. How does patent expiry impact the market for Linagliptin + Metformin?
Patent expiry opens the market to generic entrants, significantly reducing prices and eroding market share of brand-name formulations. Companies must innovate or secure new patents through formulation or delivery method innovations to maintain exclusivity.

2. What are the primary regulatory hurdles for expanding the use of Linagliptin + Metformin formulations?
Regulatory challenges include ensuring bioequivalence for generics, obtaining approval for new FDCs, and meeting safety standards across different jurisdictions, especially in emerging markets with variable regulatory rigor.

3. Who are the leading competitors in this market segment?
Major players include Novo Nordisk, Merck & Co., and generic manufacturers like Sun Pharma and Teva, each leveraging different strategic focuses like innovation, cost leadership, or regional dominance.

4. What market segments are expected to see the fastest growth?
Emerging economies in Asia and Latin America are projected to experience rapid growth due to increasing diabetes prevalence, healthcare infrastructure investments, and favorable pricing dynamics.

5. How are digital health trends influencing this market?
Integration with telemedicine, digital adherence tools, and remote monitoring enhances patient compliance and outcomes, making formulations more attractive to healthcare providers.

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References

1. International Diabetes Federation, “IDF Diabetes Atlas,” 2021.
2. U.S. Patent and Trademark Office, “Patents for Linagliptin,” 2023.
3. American Diabetes Association, “Standards of Medical Care in Diabetes,” 2022.
4. MarketWatch, “Diabetes Drugs Market Size and Forecast,” 2022.
5. European Medicines Agency, “Approved Fixed-Dose Combinations,” 2022.

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End of Report