GLYXAMBI Drug Patent Profile

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

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

This drug has five hundred and twenty-one patent family members in forty-five 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 February 1, 2029. This may change due to patent challenges or generic licensing.

There have been fifty-seven 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:	521
US Patents:	15
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	29
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

Constraining patent/regulatory exclusivity:

7,579,449*PED

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 fifteen US patents.

This potential generic entry date is based on patent 7,579,449.

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	12,364,700*PED				Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes	11,090,323*PED				Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015		RX	Yes	No	9,173,859		Y		Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes	12,178,819		Y
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015		RX	Yes	Yes	10,258,637*PED				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	206073-001	Jan 30, 2015	8,178,541
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015	8,178,541
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015	6,303,661
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-002	Jan 30, 2015	8,119,648
Boehringer Ingelheim	GLYXAMBI	empagliflozin; linagliptin	TABLET;ORAL	206073-001	Jan 30, 2015	7,078,381

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

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

Country	Patent Number	Title	Estimated Expiration
Australia	2014247092
Canada	2812519
Canada	2908635
Canada	3121761
Chile	2015002940

Supplementary Protection Certificates for GLYXAMBI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1532149	C300504	Netherlands		PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN ZOUT; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824
1532149	1190035-4	Sweden		PERIOD OF VALIDITY (FROM - UNTIL): 20230819 - 20260829
1532149	PA2011013	Lithuania		PRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001, 2011 08 24 EU/1/11/707/002, 2011 08 24 EU/1/11/707/003, 2011 08 24 EU/1/11/707/004, 2011 08 24 EU/1/11/707/005, 2011 08 24 EU/1/11/707/006, 2011 08 24 EU/1/11/707/007, 2011 08 24 EU/1/11/707/008, 2011 08 24 EU/1/11/707/00 2011082
1532149	C20110018 00046	Estonia		PRODUCT NAME: TRAJENTA-LINAGLIPTIN; REG NO/DATE: FINAL 24.08.2011
1532149	91889	Luxembourg		91889, EXPIRES: 20260824

GLYXAMBI Market Dynamics and Financial Trajectory (Empagliflozin + Linagliptin)

Last updated: July 23, 2026

Executive summary: GLYXAMBI (empagliflozin/linagliptin; Boehringer Ingelheim) is a DPP-4 inhibitor/SGLT2 inhibitor fixed-dose combination positioned in type 2 diabetes after metformin or as add-on therapy. Commercial momentum is driven by (1) class-share migration toward SGLT2 inhibitor–led cardiometabolic regimens, (2) formulary placement vs GLP-1 RA alternatives, and (3) competitive pricing pressure from cheaper generic SGLT2 components and rival fixed-dose combinations. Financial trajectory is tied to the life-cycle of its two actives: empagliflozin (Jardiance) and linagliptin (Tradjenta), with GLYXAMBI-specific sales constrained by the penetration of single-agent up-titration and by payer preference for other combination stacks (notably SGLT2+GLP-1 RA).

What is GLYXAMBI’s market positioning in type 2 diabetes therapy?

Quick answer: GLYXAMBI targets type 2 diabetes patients needing dual therapy using an SGLT2 inhibitor backbone (empagliflozin) plus a DPP-4 inhibitor (linagliptin). It competes in the add-on-to-metformin segment and in second-line combination switches when payers support SGLT2 use.

Which patient segments does GLYXAMBI serve best?

High-likelihood fit typically includes:

• Patients inadequately controlled on metformin who also benefit from SGLT2-linked cardiometabolic outcomes and who require weight-neutral or weight-sparing therapy relative to DPP-1 alternatives.
• Patients for whom DPP-4 inhibitor tolerability and dosing simplicity matter, particularly where avoidance of GLP-1 RA injections or cost barriers influence formulary decisions.
• Clinically selected patients where renal function and hypoglycemia risk profiles support SGLT2 use and where DPP-4 addition is acceptable.

How does GLYXAMBI differentiate vs GLP-1 RA and other SGLT2 combinations?

• GLYXAMBI is oral and does not carry the injection burden of GLP-1 RA.
• Compared with SGLT2+GLP-1 RA fixed-dose or preferred co-administration, GLYXAMBI generally faces lower perceived cardiometabolic potency per formulary script, since payers increasingly prioritize GLP-1 RA outcomes in weight and glycemic endpoints.
• Compared with SGLT2 monotherapy, GLYXAMBI has stronger HbA1c reduction potential through DPP-4 add-on, supporting payer willingness where dual therapy is required to meet step-therapy criteria.

Where is the product most exposed to competitive substitution?

• Any payer policy that pushes SGLT2 monotherapy first, then reserves add-on for specific HbA1c thresholds, reduces combination fixed-dose uptake.
• Any shift toward SGLT2+GLP-1 RA preferred combos increases substitution risk.

How do SGLT2 and DPP-4 class dynamics drive GLYXAMBI sales volume?

Quick answer: GLYXAMBI rides the structural demand growth of SGLT2 inhibitors (cardio-renal outcomes and label expansion) while its DPP-4 component faces a mature-class headwind as payers and clinicians increasingly route toward GLP-1 RA and SGLT2 stacks.

SGLT2 inhibitor market momentum: why it matters to GLYXAMBI

• Empagliflozin is a leading SGLT2 inhibitor in the U.S. and globally. The “halo” from Jardiance’s utilization expands potential eligible populations for empagliflozin-based combinations, including GLYXAMBI.
• Expanded clinical adoption and guideline reinforcement support SGLT2 uptake, enabling a wider “base” from which combinations can draw.

Implication for GLYXAMBI: even when fixed-dose combination switching is not the default, growth in the SGLT2-treated population increases the addressable pool.

DPP-4 inhibitor market maturity: the constraint

• Linagliptin is established and often priced and positioned as a well-tolerated, weight-neutral option.
• As GLP-1 RA access improves and SGLT2 plus GLP-1 stacks become the payer default for many patients needing additional glycemic control, DPP-4 add-on selection can soften.

Implication for GLYXAMBI: the linagliptin component can become a “decision bottleneck” when payers compare fixed-dose combination value propositions.

What pricing and payer-reimbursement pressures affect GLYXAMBI revenue?

Quick answer: Revenue pressure comes from (1) discounting within managed care, (2) competitive pricing from alternative SGLT2+drug combinations, and (3) substitution risks where generic SGLT2 components or preferred branded combinations undercut fixed-dose combination premium.

Key reimbursement dynamics

• Formulary tiering: GLYXAMBI’s net pricing is sensitive to step edits and prior authorization rules, especially where payers require evidence of failure on separate agents or prefer cheaper co-packs.
• Wholesale acquisition cost (WAC) vs net price: the difference is driven by rebates, manufacturer incentives tied to volume, and contracting with PBMs.
• Mix shifts: increases in patient populations covered on higher tiers or via commercial insurance vs Medicare Part D change the net revenue trajectory.

Competitive rebate intensity

As GLYXAMBI matures, BI’s contracting strategy typically targets:

• Maintaining formulary coverage to prevent “no-switch” inertia from single agents.
• Incentivizing combination selection through value messaging tied to oral dual therapy convenience and outcome-aligned SGLT2 use.

When does GLYXAMBI face exclusivity and patent expiration risk that could impact the financial trajectory?

Quick answer: GLYXAMBI’s future financial upside is constrained by the genericization timeline of its component molecules and associated combination-specific patents and exclusivities. The commercial risk profile depends on U.S. patent and data exclusivity status for the fixed-dose product and for the referenced actives.

How to think about expiration risk for a fixed-dose combination

• If the SGLT2 component faces earlier generic entry than the combination’s protected formulations or methods, substitution can occur even before full fixed-dose competition.
• If combination-specific patents remain strong, generics may launch only as separate-agent therapies, keeping GLYXAMBI protected from direct fixed-dose substitution but still exposed to substitution-driven volume loss.

What is the FDA and Orange Book regulatory status of GLYXAMBI?

Quick answer: GLYXAMBI is an FDA-approved fixed-dose combination of empagliflozin and linagliptin for type 2 diabetes. Its competitive “generic pathway” in the U.S. depends on patent listings in the FDA Orange Book and whether an applicant submits a Paragraph IV certification against those patents.

Orange Book and generic entry

Financial trajectory is typically most sensitive to:

• Which patents are Orange Book-listed for the drug product (composition/formulation, method-of-use, and/or manufacture).
• Whether those patents are successfully challenged through Paragraph IV ANDA submissions.
• Whether litigation leads to a 30-month stay or to settlement-driven delayed entry.

(If litigation and settlement status is required for timing-specific modeling, it must be derived from the Orange Book listings and docketed cases tied to GLYXAMBI-specific patents.)

What generic and biosimilar threats exist for GLYXAMBI?

Quick answer: Biosimilars are not relevant because GLYXAMBI is a small-molecule combination. The threats are generic ANDAs for empagliflozin and linagliptin combinations and/or separate generics that erode fixed-dose combination demand.

How generic substitution typically plays out

• “Separate generics” scenario: payers and prescribers shift from fixed-dose GLYXAMBI to generic empagliflozin plus generic linagliptin when allowed by formularies and step edits.
• “Fixed-dose generic” scenario: a direct ANDA to the combination tablet competes on price, increasing volume shift away from GLYXAMBI, often sharply after launch.

Commercial sensitivity

• If the market can be served with separate generics at similar out-of-pocket costs, fixed-dose premiums compress fast.
• If combination therapy is restricted by prior authorization or requires specific strengths not readily available generically, volume loss can be slower.

How does GLYXAMBI compare commercially with other type 2 diabetes fixed-dose combinations?

Quick answer: GLYXAMBI competes mainly with fixed-dose or co-prescribed oral dual therapies (SGLT2+other agents) and increasingly with SGLT2+GLP-1 RA regimens where payer incentives favor outcome-linked glycemic and weight effects.

Key competitive axes

1. Formulation convenience: GLYXAMBI is oral, matching payer preferences for oral adherence.
2. Outcomes and guideline fit: SGLT2-led regimens align with cardio-renal guidance; GLP-1 RA stacks often align more strongly with weight and composite glycemic endpoints.
3. Net price and rebates: BI’s contracting can preserve coverage but faces pressure from aggressive rebate strategies by competitors once patent cliffs approach.

What has driven GLYXAMBI’s financial trajectory historically (mix, demand, and class rotation)?

Quick answer: GLYXAMBI’s financial performance is driven by the share of eligible SGLT2-treated patients who choose a fixed-dose dual therapy approach versus titrating single agents. Over time, its trajectory reflects: SGLT2 class growth offset by a DPP-4 component that is less favored when payer policies prioritize SGLT2+GLP-1 RA stacks.

Main demand drivers

• Expansion of SGLT2 adoption due to cardiometabolic outcomes and clinician adoption.
• Formulary inclusion as an oral, dual-therapy option that can simplify prescribing.
• Step-therapy progression where clinicians need combination intensification without adding injectables.

Main headwinds

• Increased preference for GLP-1 RA in patients where weight loss is a high-value endpoint for payers and clinicians.
• Genericization and substitution from component generics.
• Fixed-dose combination skepticism when separate-agent co-therapy is equally reimbursed.

Which company is the incumbent and how does it manage GLYXAMBI lifecycle?

Quick answer: Boehringer Ingelheim is the incumbent for GLYXAMBI. BI’s lifecycle management typically prioritizes (1) maintaining formulary access, (2) contracting to defend net pricing, and (3) shifting portfolio emphasis toward broader SGLT2 and diabetes asset bundles as competitive pressure increases.

Portfolio interlocks

• BI’s broader diabetes commercial engine is driven by empagliflozin-centric growth. GLYXAMBI is a vehicle for empagliflozin-based combination penetration.
• The linagliptin franchise provides a second demand lever, but its growth is structurally limited compared with newer incretin-based or SGLT2+GLP-1 stacks.

Key market risk factors that can swing GLYXAMBI revenue

Quick answer: The largest revenue swing factors are (1) fixed-dose generic launch timing and Paragraph IV litigation outcomes, (2) payer formulary redesign that favors SGLT2+GLP-1 stacks or separate-agent co-therapy, and (3) net price compression from rebate pressure.

Risk list

• Direct fixed-dose ANDA launch against GLYXAMBI.
• Indirect displacement due to separate generics and “preferred formulary” co-prescribing.
• Shifts in step-therapy rules (e.g., requirement for trial of SGLT2 monotherapy prior to combination coverage).
• Increased competition from other SGLT2+dual regimens (oral/oral or oral/injectable).

Key takeaways

• GLYXAMBI’s growth depends on SGLT2 adoption and payer willingness to cover fixed-dose dual therapy.
• DPP-4 maturity and the payer pivot toward SGLT2+GLP-1 RA stacks cap long-term premium pricing.
• Financial trajectory is highly sensitive to (1) patent and Orange Book-driven generic entry timing and (2) formulary and step-therapy rules that determine whether patients move to fixed-dose combinations or separate-agent generic co-therapy.

FAQs

1) What are the main competitive products to GLYXAMBI in U.S. managed care?
Fixed-dose or preferred regimens using SGLT2 inhibitors paired with either other oral agents or GLP-1 RA stacks, which can displace DPP-4 combinations depending on formulary value assessments.

2) Does GLYXAMBI have biosimilar competition?
No. GLYXAMBI is a small-molecule fixed-dose combination; the competitive threat is generic ANDAs, not biosimilars.

3) How do payer step edits affect GLYXAMBI uptake?
Step edits and prior authorization often determine whether prescribers must document failure on SGLT2 monotherapy or separate agents before a fixed-dose combination is covered, limiting combination conversion.

4) What is the biggest risk to GLYXAMBI net sales from generics?
Direct fixed-dose generic launches and rebate-driven net price compression once separate-agent generics make co-therapy cheaper and administratively easier.

5) What commercial advantage does GLYXAMBI offer vs injectable-based combination regimens?
Oral administration reduces injection-related barriers and can align better with adherence and payer preferences where injectable access or cost is constrained.

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References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. Boehringer Ingelheim. (n.d.). GLYXAMBI prescribing information and product information. Boehringer Ingelheim.
3. FDA. (n.d.). Drug approval package and labeling for GLYXAMBI (empagliflozin/linagliptin). U.S. Food and Drug Administration.

DrugChatter Q&A for GLYXAMBI

Glyxambi empagliflozin linagliptin fda approval date 2015?
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