SOLIQUA 100/33 Drug Profile

Summary for Tradename: SOLIQUA 100/33

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for SOLIQUA 100/33
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

Recent Litigation for SOLIQUA 100/33

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC. v. AMNEAL PHARMACEUTICALS OF NEW YORK, LLC	2023-10-06
Novartis Pharmaceuticals Corporation v. MSN Pharmaceuticals Inc.	2022-10-24
In re: Entresto (Sacubitril/Valsartan) Patent Litigation	2020-03-27

See all SOLIQUA 100/33 litigation

PTAB Litigation

Petitioner	Date
Pfizer Inc.	2019-05-02
Mylan Pharmaceuticals Inc. et al.	2018-10-29
Mylan Pharmaceuticals Inc et al.	2018-09-10

See all SOLIQUA 100/33 litigation

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. General brand-side disclosures

These patents were identified from searching 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 Company Disclosures

No patents found based on 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	9,474,688	2031-10-25	Patent claims search
Sanofi-aventis U.s. Llc	SOLIQUA 100/33	insulin glargine and lixisenatide	Injection	208673	9,707,155	2039-02-26	Patent claims search

Market Dynamics and Financial Trajectory for the Biologic Drug: SOLIQUA 100/33

Introduction

SOLIQUA 100/33, a combination of insulin glargine and lixisenatide, is a significant player in the diabetes treatment market. This article delves into the market dynamics and financial trajectory of this biologic drug, highlighting its clinical efficacy, market performance, and financial implications.

Clinical Efficacy and Indications

SOLIQUA 100/33 is indicated for the treatment of adults with type 2 diabetes who are inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide. The drug has demonstrated superior HbA1c lowering compared to Lantus, a widely used basal insulin, and has shown improved blood sugar control without weight gain and with less hypoglycemia compared to premixed insulin[1][4].

Market Approval and Availability

Approved by the U.S. Food and Drug Administration (FDA) on November 21, 2016, SOLIQUA 100/33 is available by prescription in U.S. pharmacies. It is delivered in a single pre-filled SoloStar pen with a dose range of 15 to 60 Units, supporting patients' varying insulin needs[1].

Market Performance

Sales and Revenue

The sales of SOLIQUA 100/33 have shown significant growth. In Q2 2018, net sales by Sanofi increased by 260% compared to the same period the previous year, reaching DKK 127 million (approximately USD 20 million)[5]. This growth is reflected in the royalty revenue received by Zealand Pharma, which increased by 85% from the first to the second quarter of 2018[5].

Competitive Landscape

SOLIQUA 100/33 competes in a crowded diabetes treatment market but has carved out a niche with its unique combination of basal insulin and a GLP-1 receptor agonist. Its superiority in clinical trials, particularly against premixed insulin, has positioned it as a viable option for patients not achieving their HbA1c goals with other treatments[4].

Financial Trajectory

Revenue and Royalties

Zealand Pharma, which holds the intellectual property rights for lixisenatide, receives royalties from Sanofi's sales of SOLIQUA 100/33. In the first nine months of 2018, Zealand reported DKK 17.8 million (approximately USD 2.7 million) in royalty revenue from SOLIQUA 100/33 sales[2].

Milestones and Transactions

In September 2018, Zealand entered into an agreement to sell future royalties and potential commercial milestones for SOLIQUA 100/33, among other products, to Royalty Pharma Investments ICAV. This transaction resulted in a significant one-time payment of DKK 1,310.2 million (approximately USD 205 million) to Zealand, contributing to a net gain of DKK 1,098.9 million for the period[2].

Pricing and Accessibility

The daily Wholesale Acquisition Cost (WAC) price of SOLIQUA 100/33 is $127 for a 300 Unit pen, which translates to $19.90 per day at the average final dose of 47 Units. This pricing strategy aims to provide competitive value to patients and the healthcare system while facilitating patient access[1].

Patient Outcomes and Satisfaction

Clinical studies have shown that SOLIQUA 100/33 not only improves blood sugar control but also enhances patient-reported outcomes. Patients using SOLIQUA 100/33 reported greater improvements in compliance, diabetes management, and psychological health compared to those using premixed insulin. These findings are supported by the Treatment-Related Impact Measure Diabetes (TRIM-D) and Global Treatment Effectiveness Evaluation (GTEE) scores[4].

Safety Profile

The safety profile of SOLIQUA 100/33 is consistent with the established profiles of its components. Common side effects include low blood sugar, nausea, stuffy or runny nose, sore throat, diarrhea, upper respiratory tract infection, and headache. It is not recommended for people with a history of pancreatitis, type 1 diabetes, diabetic ketoacidosis, or certain stomach problems[1].

Future Outlook

Given its clinical efficacy and market performance, SOLIQUA 100/33 is poised to continue its growth trajectory. As more patients and healthcare providers recognize its benefits, especially in terms of improved blood sugar control without weight gain and reduced hypoglycemia, the demand for this drug is likely to increase.

Market Expansion

Sanofi's efforts to expand patient access and the competitive pricing strategy are expected to drive further growth. Additionally, the ongoing presentation of positive clinical data at major scientific conferences, such as the American Diabetes Association (ADA) Scientific Sessions, helps to reinforce the drug's position in the market[4].

Key Takeaways

• Clinical Efficacy: SOLIQUA 100/33 has demonstrated superior HbA1c lowering and improved patient outcomes compared to other diabetes treatments.
• Market Performance: Significant sales growth and increased royalty revenue reflect the drug's market acceptance.
• Financial Trajectory: The drug has contributed substantially to the financial performance of both Sanofi and Zealand Pharma through sales and royalty agreements.
• Pricing and Accessibility: Competitive pricing aims to balance patient access with healthcare system value.
• Patient Outcomes: Enhanced patient-reported outcomes and satisfaction scores underscore the drug's clinical and practical benefits.

FAQs

What is SOLIQUA 100/33 used for?

SOLIQUA 100/33 is used for the treatment of adults with type 2 diabetes who are inadequately controlled on basal insulin (less than 60 Units daily) or lixisenatide.

How does SOLIQUA 100/33 compare to other diabetes treatments?

SOLIQUA 100/33 has shown superior HbA1c lowering compared to Lantus and premixed insulin, with the added benefit of no weight gain and reduced hypoglycemia.

What are the common side effects of SOLIQUA 100/33?

Common side effects include low blood sugar, nausea, stuffy or runny nose, sore throat, diarrhea, upper respiratory tract infection, and headache.

How is SOLIQUA 100/33 priced?

The daily Wholesale Acquisition Cost (WAC) price of SOLIQUA 100/33 is $127 for a 300 Unit pen, which equals $19.90 per day at the average final dose of 47 Units.

What is the financial impact of SOLIQUA 100/33 on its developers?

SOLIQUA 100/33 has significantly contributed to the revenue and profitability of both Sanofi and Zealand Pharma through sales and royalty agreements.

Sources

1. Sanofi Announces Soliqua™ 100/33 Now Available in the U.S. - PR Newswire
2. Interim report for the first nine months of 2018 - Zealand Pharma
3. Full year and Q4 2022 results | AstraZeneca - AstraZeneca
4. New Soliqua 100/33 data shows improved blood sugar control without weight gain versus premixed insulin - PR Newswire
5. FORM 6-K - SEC Filings | Zealand Pharma - Zealand Pharma