Sotagliflozin - Generic Drug Details

What are the generic drug sources for sotagliflozin and what is the scope of patent protection?

Sotagliflozin is the generic ingredient in one branded drug marketed by Lexicon Pharms Inc and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sotagliflozin has eighty-one patent family members in thirty-three countries.

One supplier is listed for this compound.

Summary for sotagliflozin

International Patents:	81
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	43
Patent Applications:	396
What excipients (inactive ingredients) are in sotagliflozin?	sotagliflozin excipients list
DailyMed Link:	sotagliflozin at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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 sotagliflozin

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

Sponsor	Phase
King's College London	Phase 4
Juvenile Diabetes Research Foundation	Phase 4
Steno Diabetes Center Copenhagen	Phase 4

See all sotagliflozin clinical trials

Pharmacology for sotagliflozin

Drug Class	Sodium-Glucose Cotransporter 2 Inhibitor
Mechanism of Action	P-Glycoprotein Inhibitors Sodium-Glucose Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for sotagliflozin

A10BK	Sodium-glucose co-transporter 2 (SGLT2) inhibitors
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

US Patents and Regulatory Information for sotagliflozin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-002	May 26, 2023		RX	Yes	Yes	7,781,577		Y	Y
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-001	May 26, 2023		RX	Yes	No	7,781,577		Y	Y
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-001	May 26, 2023		RX	Yes	No	8,217,156		Y	Y
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-001	May 26, 2023		RX	Yes	No	8,476,413		Y	Y
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-002	May 26, 2023		RX	Yes	Yes	8,476,413		Y	Y

EU/EMA Drug Approvals for sotagliflozin

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Guidehouse Germany GmbH	Zynquista	sotagliflozin	EMEA/H/C/004889 Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.,	Withdrawn	no	no	no	2019-04-26

International Patents for sotagliflozin

Country	Patent Number	Title	Estimated Expiration
Ukraine	106048	ТВЕРДЫЕ ФОРМЫ (2S,3R,4R,5S,6R)-2-( 4-ХЛОР-3(4-ЭТОКСИБЕНЗИЛ)ФЕНИЛ)-6-(МЕТИЛТИО)ТЕТРАГИДРО-2H-ПИРАН-3,4,5-ТРИОЛА И ИХ ПРИМЕНЕНИЕ;ТВЕРДІ ФОРМИ (2S,3R,4R,5S,6R)-2-(4-ХЛОР-3(4-ЕТОКСИБЕНЗИЛ)ФЕНІЛ)-6-(МЕТИЛТІО)ТЕТРАГІДРО-2H-ПІРАН-3,4,5-ТРІОЛУ І ЇХ ЗАСТОСУВАННЯ (SOLID FORMS OF (2S, 3R, 4R, 5S, 6R)-2-(4-CHLORO-3-(4-ETHOXYBENZYL)PHENYL)-6-(METHYLTHIO)TETRAHYDRO-2H-PYRAN-3,4,5-TRIOL AND USE THEREOF)
Israel	197836	אנלוגים של פלוריזין ותכשירים רוקחיים המכילים אותם (Phlorizin analogs and pharmaceutical compositions comprising them)
Taiwan	I499414
South Africa	201100175	SOLID FORMS OF (2S,3R,4R,5S,6R)-2-(4-CHLORO-3-(4-ETHOXYBENZYL)PHENYL)-6-(METHYLTHIO)TETRAHYDRO-2H-PYRAN-3,4,5-TRIOL AND METHODS OF THEIR USE
South Korea	20150002889	PHLORIZIN ANALOGS AS INHIBITORS OF SODIUM GLUCOSE CO-TRANSPORTER 2

Supplementary Protection Certificates for sotagliflozin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2089361	132019000000113	Italy		PRODUCT NAME: SOTAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYNQUISTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1363, 20190430
2089361	CA 2019 00042	Denmark		PRODUCT NAME: SOTAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/19/1363 20190430
2089361	122019000077	Germany		PRODUCT NAME: SOTAGLIFLOZIN, ODER EIN PHARMAZEUTISCH ZULAESSIGES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1363 20190426
2089361	2019/044	Ireland		PRODUCT NAME: SOTAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1363 20190430
2089361	301003	Netherlands		PRODUCT NAME: SOTAGLIFLOZIN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1363 20190430

Sotagliflozin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sotagliflozin

Introduction

Sotagliflozin, marketed as INPEFA, has emerged as a significant player in the treatment of heart failure, particularly for patients with comorbid diabetes. This article delves into the market dynamics and financial trajectory of sotagliflozin, highlighting its growth prospects, economic impact, and cost-effectiveness.

Market Growth and Projections

The sotagliflozin market is anticipated to experience robust growth over the forecast period from 2023 to 2031. This expansion is driven by the increasing prevalence of heart failure and diabetes, as well as the drug's efficacy in reducing hospital readmissions and improving patient outcomes[1].

Market Segmentation

The market is segmented based on type (purity ≥ 98%, purity ≥ 99%) and application (research institutes, pharmaceutical companies, others), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). This segmentation helps in understanding the diverse market dynamics and identifying key growth areas[1].

Economic Impact on Health Systems

Sotagliflozin has demonstrated a positive economic impact on health systems, particularly those participating in alternative payment models (APMs).

Alternative Payment Models

Studies have shown that the adoption of sotagliflozin results in significant financial benefits under various APMs, including the Hospital Readmissions Reduction Program (HRRP), Bundled Payments for Care Improvement-Advanced program (BPCI), and Medicare Shared Savings Program for Accountable Care Organizations (ACO). On a per-admission basis, sotagliflozin adoption led to a $4,720 margin increase for HRRP, $1,200 for BPCI, and $1,078 for ACO[2][5].

Cost Savings

At a total health system level, the adoption of sotagliflozin is estimated to generate substantial cost savings. For instance, a median-sized U.S. community hospital could realize an annual margin increase of $305,604 for HRRP, $100,106 for BPCI, and $31,029 for ACO[2][5].

Cost-Effectiveness Analysis

Several studies have evaluated the cost-effectiveness of sotagliflozin compared to standard of care (SoC) for patients with heart failure and comorbid diabetes.

Reduction in Hospital Readmissions and Mortality

Sotagliflozin has been shown to decrease annualized rehospitalization rates by 34.5%, emergency department visits by 40.0%, and annualized mortality by 18.0% compared to SoC. These reductions result in a net gain in quality-adjusted life years (QALYs) of 0.425 for sotagliflozin versus SoC[3][4].

Incremental Cost-Effectiveness Ratio (ICER)

Despite the increased pharmaceutical costs, the use of sotagliflozin is considered cost-effective. The incremental cost-effectiveness ratio (ICER) for sotagliflozin relative to SoC is estimated at $45,596 per QALY over a 30-year time horizon. This indicates that sotagliflozin provides significant health benefits at a reasonable additional cost[3][4].

Budget Impact Analysis

From a payer perspective, the adoption of sotagliflozin leads to increased pharmacy costs but also results in reduced medical costs due to lower readmission rates and emergency department visits.

Commercial and All-Payer Scenarios

In commercial payer scenarios, the increased pharmacy costs of $7,276 per patient per year are partially offset by reduced medical costs of $4,729 per patient per year. Similarly, in all-payer scenarios, the annual medical costs per patient are reduced by $2,367, resulting in a net increase in total spending per patient[4].

Industry Expert Insights

Industry experts emphasize the clinical and financial benefits of sotagliflozin. For example, Craig Granowitz, M.D., Ph.D., Lexicon's senior vice president and chief medical officer, noted that "there is a growing body of evidence that the use of INPEFA for patients hospitalized with heart failure who suffer from diabetes leads to significant value for payors and clinical institutions"[2].

Market Drivers and Restraints

The market for sotagliflozin is driven by several factors, including the increasing prevalence of heart failure and diabetes, the drug's efficacy in reducing hospital readmissions, and the positive financial impact on health systems. However, the market is also restrained by factors such as increased pharmaceutical costs and the need for ongoing clinical evidence to support long-term use[1].

Competitive Landscape

The competitive landscape for sotagliflozin involves several key players, including Lexicon Pharmaceuticals, which has been at the forefront of promoting the drug's benefits through various studies and analyses. The market is expected to become more competitive as other pharmaceutical companies enter the space with similar or alternative treatments[1].

Regional Market Analysis

The market for sotagliflozin is geographically diverse, with significant growth expected in regions such as North America, Europe, and Asia-Pacific. These regions are characterized by high healthcare spending, advanced healthcare infrastructure, and a growing awareness of the benefits of sotagliflozin[1].

Future Outlook

The future outlook for sotagliflozin is promising, with continued growth anticipated as more health systems adopt alternative payment models and recognize the clinical and financial benefits of the drug. Ongoing research and clinical trials will further solidify sotagliflozin's position in the market.

"There is a growing body of evidence that the use of INPEFA for patients hospitalized with heart failure who suffer from diabetes leads to significant value for payors and clinical institutions," - Craig Granowitz, M.D., Ph.D., Lexicon's senior vice president and chief medical officer[2].

Key Takeaways

• Sotagliflozin is expected to experience robust market growth from 2023 to 2031 due to its efficacy in treating heart failure and comorbid diabetes.
• The drug offers significant financial benefits to health systems participating in alternative payment models.
• Sotagliflozin reduces hospital readmissions, emergency department visits, and mortality, leading to a net gain in QALYs.
• Despite increased pharmaceutical costs, sotagliflozin is considered cost-effective with an ICER of $45,596 per QALY.
• The market is driven by the increasing prevalence of heart failure and diabetes, and restrained by factors such as increased pharmaceutical costs.

FAQs

What is sotagliflozin used for?

Sotagliflozin is used for the treatment of patients hospitalized with heart failure and comorbid diabetes.

How does sotagliflozin impact hospital readmissions?

Sotagliflozin reduces annualized rehospitalization rates by 34.5% compared to standard of care.

What are the financial benefits of sotagliflozin under alternative payment models?

Sotagliflozin adoption results in significant margin increases for health systems under HRRP, BPCI, and ACO, such as a $4,720 margin increase for HRRP per admission.

Is sotagliflozin cost-effective?

Yes, sotagliflozin is considered cost-effective with an incremental cost-effectiveness ratio (ICER) of $45,596 per QALY over a 30-year time horizon.

What are the key drivers of the sotagliflozin market?

The key drivers include the increasing prevalence of heart failure and diabetes, the drug's efficacy in reducing hospital readmissions, and the positive financial impact on health systems.

Sources

1. Market Research Intellect, "Global Sotagliflozin Market Size, Trends and Projections".
2. GlobeNewswire, "New Published Data Highlights Potential Cost-Savings of INPEFA-sotagliflozin for Heart Failure".
3. PubMed, "Cost-effectiveness of sotagliflozin for the treatment of patients with heart failure and comorbid diabetes".
4. BioSpace, "Data From Two Studies Demonstrating Positive Financial Impact of INPEFA-sotagliflozin to be Presented at the Academy of Managed Care Pharmacy AMCP Nexus 2023 National Meeting".
5. U.S. Pharmacist, "Cost Savings Associated With Sotagliflozin Use".