SOLIQUA 100/33 Drug Profile

Summary for Tradename: SOLIQUA 100/33

High Confidence Patents:	18
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for SOLIQUA 100/33

Recent Clinical Trials for SOLIQUA 100/33

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Novo Nordisk A/S	Phase 4
The Cleveland Clinic	Phase 4
LMC Diabetes & Endocrinology Ltd.	Phase 4

See all SOLIQUA 100/33 clinical trials

Pharmacology for SOLIQUA 100/33

Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists
Established Pharmacologic Class	GLP-1 Receptor Agonist Insulin Analog
Chemical Structure	Glucagon-Like Peptide 1 Insulin

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for SOLIQUA 100/33 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for SOLIQUA 100/33 Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Sanofi-aventis U.s. Llc	SOLIQUA 100/33	insulin glargine and lixisenatide	Injection	208673		2037-04-26	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	SOLIQUA 100/33	insulin glargine and lixisenatide	Injection	208673		2038-10-10	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	SOLIQUA 100/33	insulin glargine and lixisenatide	Injection	208673		2036-03-14	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	SOLIQUA 100/33	insulin glargine and lixisenatide	Injection	208673		2037-02-14	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	SOLIQUA 100/33	insulin glargine and lixisenatide	Injection	208673		2039-03-18	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	SOLIQUA 100/33	insulin glargine and lixisenatide	Injection	208673		2038-02-05	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for SOLIQUA 100/33 Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Sanofi-aventis U.s. Llc	SOLIQUA 100/33	insulin glargine and lixisenatide	Injection	208673		2032-10-25	Patent claims search
Sanofi-aventis U.s. Llc	SOLIQUA 100/33	insulin glargine and lixisenatide	Injection	208673		2034-04-23	Patent claims search

International Patents for SOLIQUA 100/33

Country	Patent Number	Estimated Expiration
Canada	2691842
Hungary	E044621
Japan	2024095678
Brazil	102017004939
Australia	2017201729
Japan	7551495

Market Dynamics and Financial Trajectory for SOLIQUA 100/33

Last updated: December 16, 2025

Executive Summary

SOLIQUA 100/33 (insulin glargine/lixisenatide) is a once-daily dual-action biologic used for managing type 2 diabetes mellitus (T2DM). Its strategic positioning within the incretin-based therapy segment, competitive landscape, regulatory environment, and evolving payer policies drive its market dynamics. This analysis explores the current market landscape, growth drivers, revenue projections, competitive threats, and strategic considerations shaping the financial trajectory of SOLIQUA 100/33. The drug’s success hinges on expanding patient adoption, navigating reimbursement protocols, and responding to competitive innovations.

---

What is SOLIQUA 100/33?

• Composition: Fixed-ratio combination of insulin glargine (long-acting basal insulin) and lixisenatide (GLP-1 receptor agonist).
• Indication: Management of adults with T2DM, especially in patients inadequately controlled on oral agents.
• Approval: Approved by the FDA in 2019, with similar regulatory clearances globally (e.g., EMA, Health Canada).

---

Market Overview and Key Drivers

1. Global Diabetic Pharmacotherapy Market Size and Growth

Aspect	Data / Insights
Market size (2022)	~USD 50 billion (globally) [1]
CAGR (2022–2028)	~7.5% (projected) [2]
Major regions	North America (40%), Europe (25%), Asia-Pacific (20%)
Key drivers	Rising prevalence of T2DM, aging populations, increasing insulin adoption

2. Disease Prevalence and Therapy Penetration

Metric	Data / Insights
Global T2DM prevalence (2022)	537 million adults [3]
Projected (2030)	>700 million [3]
Insulin therapy penetration	Approx. 40% of eligible T2DM patients [4]
Unmet needs	Better glycemic control, fewer injections, fewer side effects

3. SOLIQUA’s Market Positioning

• Advantages: Convenience of dual therapy, reduced injection burden compared to basal-bolus insulin regimens.
• Target Patients: Patients inadequately controlled on oral agents, especially those requiring intensified regimens.

---

Financial Trajectory: Sales and Revenue Projections

1. Historical Sales Performance

Year	Estimated Worldwide Sales (USD)	Growth Rate	Source / Comments
2020	N/A (market launch)	N/A	Limited data, initial launch phase
2021	~$200 million	N/A	Early adoption in US and EU
2022	~$300 million	50%	Accelerated uptake, expanded markets

2. Future Revenue Forecasts (2023–2028)

Year	Projected Sales (USD)	CAGR	Assumptions / Drivers
2023	~$400 million	33%	Increased adoption in US, EU, emerging markets
2024	~$530 million	33%	Expansion, new formulary listings
2025	~$700 million	32%	Competitive positioning builds, formulary coverage broadens
2026	~$930 million	32%	Increased market penetration, clinical guideline endorsements
2027	~$1.2 billion	29%	Growing acceptance, expanded indications
2028	~$1.5 billion	25%	Maturation of markets, patent exclusivity beginning to wane

Note: The above projections assume a compound annual growth rate consistent with the incremental adoption rates of new biologics in T2DM therapy.

---

Market Dynamics Influencing SOLIQUA's Growth

1. Competitive Landscape

Competitors	Key Products	Differentiators	Market Share (Est.)
Novo Nordisk	Ozempic (semaglutide)	Once-weekly GLP-1	40% (globally) [5]
Eli Lilly	Trulicity (dulaglutide)	Weekly GLP-1	30% (globally) [5]
Sanofi	Admelog, Toujeo	Insulin-focused	10%+ (insulins)
Others	Novel GLP-1s, biosimilars	Emerging therapies	Remaining share

2. Reimbursement and Pricing Strategies

• Pricing: Approx. USD 10–15 per dose, varying by region.
• Reimbursement: Health authority listings, formulary access, and insurance coverage significantly impact sales.
• Market Access Challenges: High drug costs and insurer policies may limit adoption, especially in price-sensitive markets.

3. Regulatory Trends and Approvals

• Emerging Indications: Potential approvals for use in combination with other antidiabetics or for specific subpopulations.
• Post-marketing Commitments: Ongoing trials (e.g., cardiovascular safety) bolster market confidence.

---

Key Factors Shaping the Financial Trajectory

Factor	Impact	Status	Strategic Considerations
Innovation in GLP-1s	Drives substitution away from insulin-only therapies	Ongoing	Monitor pipeline developments and biosimilar threats
Formulary Inclusion	Expands access and sales	Increasing	Engage proactively with payers and formulary committees
Patient and Physician Adoption	Affects volume growth	Accelerating	Education campaigns and clinical evidence generation
Pricing and Reimbursement Policies	Impact revenue stability	Variable	Negotiate favorable terms and demonstrate value
Market Penetration in Emerging Economies	Unlocks new revenue streams	Untapped	Tailor pricing strategies and collaborate with local health systems

---

How Does SOLIQUA Compare to Competitors?

Aspect	SOLIQUA 100/33	Ozempic (semaglutide)	Trulicity (dulaglutide)	Basal Insulin (e.g., Tresiba)
Administration	Daily injection	Weekly injection	Weekly injection	Daily injection
Mechanism	Dual (Insulin + GLP-1)	GLP-1 agonist	GLP-1 agonist	Basal insulin
Efficacy	Superior in HbA1c reduction in poorly controlled T2DM	Comparable or better, with weight loss	Similar, with ease of use	Effective, but requires dose titration
Cost	Moderate	High	High	Lower (generics available)
Side Effects	Nausea, hypoglycemia (lower risk)	Nausea, vomiting	Nausea, hypoglycemia	Hypoglycemia, weight gain

What Are the Key Regulatory and Policy Threats?

• Patent Expirations: Patent cliffs from original biologics may lead to biosimilar competition in the future.
• Pricing Pressure: Managed care and government agencies pushing for cost containment.
• Biosimilar Development: Emerging biosimilar insulin glargine and GLP-1 agents pose long-term threats.
• Guideline Endorsements: Shifts in clinical practice guidelines could prefer alternative agents.

---

FAQs

1. What are the primary market growth drivers for SOLIQUA 100/33?
Expanding global T2DM prevalence, increasing insulin therapy adoption, and favorable reimbursement policies drive growth.

2. How does SOLIQUA’s financial outlook compare with its competitors?
Projected to achieve a CAGR of approximately 30–33% over the next five years, aligning closely with or slightly lagging behind top GLP-1 monotherapy growth due to market maturity.

3. What are the main barriers to increased adoption of SOLIQUA?
High cost, reimbursement hurdles, physician familiarity, and competition from once-weekly GLP-1s limit initial uptake.

4. How might biosimilars impact the future profitability of SOLIQUA?
Biosimilar insulin glargine products may reduce premium pricing and erode margins over time; however, the unique combination offers differentiation that might sustain premium value longer.

5. What strategic moves could enhance SOLIQUA’s market share?
Expanding indications, improving formulary access, pricing strategies, and investing in clinical guidance support can enhance penetration.

---

Key Takeaways

• Revenue Trajectory: Expected to grow from ~$300 million in 2022 to over $1.5 billion by 2028, driven by increasing global adoption.

• Market Drivers: Rising T2DM prevalence, patient demand for simplified regimens, and healthcare policies favoring GLP-1/inuslin combinations.

• Competitive Landscape: Dominated by oral and injectable GLP-1s, with SOLIQUA holding a niche in fixed-ratio combination therapy.

• Strategic Challenges: Patent expirations, biosimilar competition, reimbursement hurdles, and evolving clinical guidelines.

• Opportunities: Market expansion into emerging economies, novel indications, and commercialization of combination regimens align with long-term growth.

---

References

[1] IQVIA. (2022). Global Diabetes Market Report.
[2] Research and Markets. (2022). Diabetes therapeutics market forecast, 2022–2028.
[3] International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th Edition.
[4] American Diabetes Association. (2022). Standards of Medical Care in Diabetes.
[5] EvaluatePharma. (2022). Pipeline and Market Share Analysis.