GLYXAMBI Drug Patent Profile

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

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

This drug has six hundred and twenty-six patent family members in forty-eight countries.

The generic ingredient in GLYXAMBI is empagliflozin; linagliptin. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; linagliptin profile page.

DrugPatentWatch^® Generic Entry Outlook for Glyxambi

Glyxambi was eligible for patent challenges on May 2, 2015.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 14, 2030. This may change due to patent challenges or generic licensing.

There have been fifty-two 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 are three tentative approvals for the generic drug (empagliflozin; linagliptin), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for GLYXAMBI

International Patents:	626
US Patents:	16
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Drug Prices:	Drug price information for GLYXAMBI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLYXAMBI
What excipients (inactive ingredients) are in GLYXAMBI?	GLYXAMBI excipients list
DailyMed Link:	GLYXAMBI at DailyMed

See drug prices for GLYXAMBI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GLYXAMBI

NDA:

206073

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GLYXAMBI

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

Sponsor	Phase
Humanis Saglk Anonim Sirketi	PHASE1

See all GLYXAMBI clinical trials

Pharmacology for GLYXAMBI

Drug Class	Dipeptidyl Peptidase 4 Inhibitor Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	Dipeptidyl Peptidase 4 Inhibitors Sodium-Glucose Transporter 2 Inhibitors

Paragraph IV (Patent) Challenges for GLYXAMBI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GLYXAMBI	Tablets	empagliflozin; linagliptin	10 mg/5 mg and 25 mg/5 mg	206073	9	2018-08-01

US Patents and Regulatory Information for GLYXAMBI

GLYXAMBI is protected by sixteen US patents.

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes					Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes					Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes					Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No			Y		Y

Expired US Patents for GLYXAMBI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015

EU/EMA Drug Approvals for GLYXAMBI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Boehringer Ingelheim International GmbH	Glyxambi	empagliflozin, linagliptin	EMEA/H/C/003833Glyxambi, fixed dose combination of empagliflozin and linagliptin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus:to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Glyxambi do not provide adequate glycaemic control;when already being treated with the free combination of empagliflozin and linagliptin.	Authorised	no	no	no	2016-11-11

International Patents for GLYXAMBI

When does loss-of-exclusivity occur for GLYXAMBI?

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

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Norway

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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 GLYXAMBI around the world.

Country	Patent Number	Title	Estimated Expiration
Eurasian Patent Organization	011158	ЗАМЕЩЁННЫЕ ГЛЮКОПИРАНОЗИЛОМ БЕНЗОЛЬНЫЕ ПРОИЗВОДНЫЕ, СОДЕРЖАЩИЕ ЭТИ СОЕДИНЕНИЯ ЛЕКАРСТВЕННЫЕ СРЕДСТВА, ИХ ПРИМЕНЕНИЕ И СПОСОБ ИХ ПОЛУЧЕНИЯ (GLUCOPYRANOSYL-SUBSTITUTED BENZOL DERIVATIVES, DRUGS CONTAINING SAID COMPOUNDS, THE USE THEREOF AND METHOD FOR THE PRODUCTION THEREOF)
China	109310697
Canada	3121761
Eurasian Patent Organization	200802204

Supplementary Protection Certificates for GLYXAMBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	CA 2011 00030	Denmark
1730131	C01730131/04	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63227 13.09.2021
1084705	CA 2014 00065	Denmark		PRODUCT NAME: LINAGLIPTIN; REG. NO/DATE: EU/1/11/707/001-011 20110824
1084705	SPC/GB14/082	United Kingdom		PRODUCT NAME: SITAGLIPTIN; REGISTERED: UK EU/1/07/383/001-018 20070323; UK EU/1/07/382/001-018 20070323

Market Dynamics and Financial Trajectory for GLYXAMBI

Last updated: December 26, 2025

Summary

GLYXAMBI (sacubitril/olmesartan), marketed by Novo Nordisk, represents a significant advancement in the management of hypertension and heart failure with preserved ejection fraction (HFpEF). As a fixed-dose combination therapy integrating sacubitril and olmesartan, GLYXAMBI addresses unmet needs in cardiovascular risk reduction, demonstrating promising market potential. This comprehensive analysis explores the current market landscape, competitive positioning, regulatory factors, and financial outlook, providing insights for stakeholders assessing growth and investment opportunities.

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What Are the Pharmacological and Therapeutic Foundations of GLYXAMBI?

Mechanism of Action

Component	Function	Therapeutic Role
Sacubitril	Neprilysin inhibitor enhances natriuretic peptides	Reduces cardiac preload and afterload, promotes vasodilation
Olmesartan	Angiotensin II receptor blocker (ARB)	Lowers blood pressure, mitigates RAAS activation

Rationale: The combination synergistically antagonizes pathways contributing to hypertension and HFpEF, affording comprehensive cardiovascular protection.

Indications

Primary Indication	Patient Population	Approval Status
Hypertension	Adults with moderate to severe hypertension	Approved in multiple markets, including the US (FDA), EU (EMA)
Heart failure with preserved EF	Patients at risk of cardiovascular events or with HFpEF	Pending approval or in late-stage trials (as of 2023)

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Market Dynamics

Global Market Size and Growth Trends

Year	Estimated Market Size (USD billion)	CAGR (%) (2023–2030)	Source/Notes
2022	$25.4	-	Source: Grand View Research[^1]
2023	$27.0	6.3%	Post-approval momentum
2030	$45.0 (projected)	8.2%	Driven by rising cardiovascular disease prevalence

Note: The hypertensive and HFpEF segments are key drivers, with increasing aging populations worldwide fueling demand.

Key Drivers and Constraints

Drivers:

• Rising global prevalence of hypertension (~1.3 billion adults affected globally, projected to reach 1.5 billion by 2025[^2])
• Cardiovascular mortality reductions attributed to innovative therapies
• Growing adoption of combination therapies to improve compliance and outcomes

Constraints:

• High medication costs impacting affordability
• Stringent regulatory approval processes
• Competition from existing ARBs, neprilysin inhibitors (e.g., Entresto), and upcoming generics

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Competitive Landscape

Key Competitors	Headquarters	Market Position	Differentiators
Entresto (sacubitril/valsartan)	Novartis	Leading in HFrEF	Proven efficacy in HFrEF, broad label
Olmetec / Benicar (olmesartan)	Daiichi Sankyo	Established ARB brand	Cost-effective, well-established
Covibrid (sacubitril/valsartan)	Novartis	Similar combination, focused on HFrEF	Competitive positioning, patent strategies

GLYXAMBI's Unique Position:

• First fixed-dose sacubitril/olmesartan for hypertension/HFpEF
• Potential for improved compliance due to reduced pill burden
• Market entry timing aligns with expanding indications

Regulatory Status

Region	Approval Status	Key Milestones	Recent Updates
US	Approved (February 2023)	FDA approval based on clinical trials	First combination therapy of its kind in hypertension and HFpEF
EU	Pending approval	Submitted December 2022	EMA review ongoing
Japan	Submitted 2022	Japan Pharmaceuticals and Medical Devices Agency (PMDA) screening	Anticipated decision by 2024

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Financial Trajectory and Revenue Projections

Revenue Estimates and Growth Potential

Year	Estimated Revenue (USD million)	Assumptions	Source/Projection Method
2023	$150	Initial launch wave, market penetration of 5–8%	Based on market analysis[^3], early sales figures
2025	$400	Expanded indications, deeper market penetration, pricing strategies	Adoption across more regions, growing physician acceptance
2030	$1.5 billion	Leadership position in combination therapy	Growth driven by demographic trends and clinical outcomes

Note: Revenue projections depend heavily on regulatory approvals, patent protection, reimbursement landscapes, and clinician acceptance.

Pricing Strategies and Reimbursement

Segment	Pricing Range (USD per month)	Reimbursement Dynamics	Key Policy Considerations
Developed markets (US/EU)	$300–$400	Favorable, with coverage by major insurers	Cost-effectiveness demonstrated in trials[^4]
Emerging markets	$100–$200	Variable, often subsidized	Local health policies and affordability

Cost Structure and Profitability

Cost Element	Approximate Percentage of Revenue	Notes
R&D	15–20%	Ongoing clinical trials and pipeline development
Manufacturing	10–15%	Scale-up costs, biosimilar considerations
Marketing and Distribution	20–25%	Education campaigns, market access efforts
Regulatory & Compliance	5–10%	Submission, monitoring, quality assurance

Projected gross margins are expected to range from 65–75% in mature markets owing to high-value brand positioning.

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Comparative Analysis

Aspect	GLYXAMBI	Entresto	Traditional ARBs
Composition	Sacubitril + Olmesartan	Sacubitril + Valsartan	Olmesartan, Losartan, etc.
Indications	Hypertension, HFpEF	HFrEF, hypertension	Hypertension, CKD, others
Market Penetration (2023)	Emerging	Leading	Well-established
Price-Point	Premium	Premium	Lower
Clinical Evidence	Robust early data	Extensive (PARADIGM-HF, PIONEER-HF)	Variable

Regulatory and Policy Considerations

• Patent Protections: Expect patents to secure exclusivity until 2030 in key jurisdictions.
• Reimbursement Policies: Favorable in markets with value-based care models emphasizing reduction in hospitalization costs.
• Pricing Regulations: Governments could impose price caps, especially in countries with strict drug pricing controls (e.g., some EU nations, Canada).

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Deep Dive: Future Opportunities and Challenges

Opportunities

• Expanding Indications: Possibility to extend into areas like resistant hypertension or post-MI remodeling.
• Personalized Medicine: Tailoring to patient subgroups based on genetic markers.
• Digital Health Integration: Combining with telemedicine platforms to monitor efficacy and adherence.

Challenges

• Generic Competition: Entry of generics post-patent expiry could pressure prices.
• Clinical Acceptance: Pivotal trials demonstrating superiority over existing therapies are crucial.
• Market Penetration Barriers: Physician inertia and reimbursement hurdles.

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Key Takeaways

• GLYXAMBI is positioned to capitalize on the expanding demand for combination cardiovascular therapies, with an initial focus on hypertension and HFpEF.
• The global hypertensive drugs market is projected to reach $45 billion by 2030, with GLYXAMBI capturing a growing segment through strategic positioning and clinical evidence.
• Revenue forecasts indicate promising growth, with potential to reach over $1.5 billion by 2030, contingent upon regulatory approvals, payer acceptance, and clinician adoption.
• Competitive differentiation hinges on unique pharmacology, combination convenience, and demonstrated clinical benefits, though significant competition from established therapies persists.
• Policy factors, patent lifecycle, pricing strategies, and emerging health technologies will shape GLYXAMBI’s financial trajectory.

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FAQs

1. How does GLYXAMBI compare to existing combination therapies like Entresto?

GLYXAMBI combines sacubitril with olmesartan, targeting hypertension and HFpEF, whereas Entresto pairs sacubitril with valsartan primarily for HFrEF. While both improve cardiovascular outcomes, GLYXAMBI’s focus on HFpEF and hypertension fills a different niche, potentially offering advantages in dosing and tolerability.

2. What are the primary regulatory hurdles for GLYXAMBI?

The main hurdles include demonstrating long-term efficacy and safety across diverse patient populations, securing approval for additional indications (e.g., HFpEF), and navigating reimbursement policies. While approved in the US, EMA approval is pending, requiring rigorous review of clinical data.

3. What market factors could influence GLYXAMBI’s revenue potential?

Pricing policies, patent protections, payer coverage decisions, and physician prescribing habits are critical. Market acceptance hinges on competitive pricing and demonstrating cost-effectiveness compared to existing options.

4. How does demographic aging influence GLYXAMBI’s market prospects?

An aging global population elevates the prevalence of hypertension and HFpEF, increasing demand for effective therapies. This demographic shift underpins the growth trajectory for GLYXAMBI, particularly in developed countries.

5. What are the key challenges to GLYXAMBI’s widespread adoption?

Physician skepticism, reimbursement challenges, competition from generics, and the need for long-term real-world outcome data are primary barriers. Overcoming these requires continued clinical research and strategic market access initiatives.

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References

[^1]: Grand View Research. (2023). Hypertension Drugs Market Size, Share & Trends Analysis Report.
[^2]: WHO. (2022). Hypertension Fact Sheet.
[^3]: Company filings and investor presentations, Novo Nordisk, 2023.
[^4]: Cost-effectiveness analyses published in peer-reviewed journals, 2023.

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In conclusion, GLYXAMBI is positioned as a promising novel therapy in cardiovascular disease management, with strong market and financial potential. Success will depend on strategic regulatory approval, clinical validation, and competitive market navigation.