INPEFA Drug Patent Profile

When do Inpefa patents expire, and when can generic versions of Inpefa launch?

Inpefa is a drug marketed by Lexicon Pharms Inc and is included in one NDA. There are three patents protecting this drug.

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

The generic ingredient in INPEFA is sotagliflozin. One supplier is listed for this compound. Additional details are available on the sotagliflozin profile page.

DrugPatentWatch^® Generic Entry Outlook for Inpefa

Inpefa will be eligible for patent challenges on May 26, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 26, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for INPEFA

International Patents:	81
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for INPEFA
What excipients (inactive ingredients) are in INPEFA?	INPEFA excipients list
DailyMed Link:	INPEFA at DailyMed

See drug prices for INPEFA

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216203

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.

Pharmacology for INPEFA

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

US Patents and Regulatory Information for INPEFA

INPEFA is protected by three US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
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	216203-001	May 26, 2023		RX	Yes	No
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-002	May 26, 2023		RX	Yes	Yes	8,217,156		Y	Y

EU/EMA Drug Approvals for INPEFA

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 INPEFA

When does loss-of-exclusivity occur for INPEFA?

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

Argentina

Australia

Austria

Brazil

Canada

China

Colombia

Denmark

Eurasian Patent Organization

European Patent Office

France

Germany

Hong Kong

Hungary

Israel

Japan

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

South Africa

South Korea

Spain

Taiwan

Ukraine

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 INPEFA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2308841	Analogues de phlorizine comme inhibiteurs de SGLT2 (Phlorizin analogs as SGLT2 inhibitors)
Japan	2013079243	PHLORIZIN ANALOG AS INHIBITOR OF SODIUM GLUCOSE CO-TRANSPORTER 2
New Zealand	575811	INHIBITORS OF SODIUM GLUCOSE CO-TRANSPORTER 2 AND METHODS OF THEIR USE

Supplementary Protection Certificates for INPEFA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2089361	1990043-0	Sweden		PRODUCT NAME: SOTAGLIFLOZIN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. 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
2089361	42/2019	Austria		PRODUCT NAME: SOTAGLIFLOZIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1363 (MITTEILUNG) 20190430

Market Dynamics and Financial Trajectory for INPEFA

Introduction

INPEFA, developed by Lexicon Pharmaceuticals, is a groundbreaking drug that has recently entered the market, targeting heart failure treatment by inhibiting the SGLT1 and SGLT2 proteins. Despite its promising clinical benefits, the drug's market reception and financial performance have been subject to various factors. Here, we delve into the market dynamics and financial trajectory of INPEFA.

Clinical Benefits and Unique Value Proposition

INPEFA stands out as the first dual SGLT1 and SGLT2 inhibitor, offering rapid improvements in heart failure outcomes and major adverse cardiovascular events within approximately 3 months. The post hoc analysis from the SCORED trial revealed significant risk reductions in cardiovascular deaths and heart failure events, which could drive its adoption among clinicians and payers[1].

Market Reception and Competition

Despite its clinical advantages, INPEFA faces competition from established SGLT2 inhibitors like Jardiance and Farxiga. However, its unique dual inhibition mechanism and rapid clinical benefits position it favorably in the market. Investor concerns about market reception have impacted Lexicon's stock price, which is currently down by around 60% from its peak in May[1].

Increasing Traction and Prescription Demand

Encouragingly, INPEFA's prescriber base has grown significantly, with around 500 healthcare professionals prescribing the drug in Q3 2024. Clinical demand has outpaced filled prescriptions by fivefold, indicating strong potential for increased prescriptions as INPEFA secures broader payer coverage and formulary placements. Express Scripts has designated INPEFA as a preferred product on its Medicare and commercial formularies, enhancing access for insured patients[1].

Payer Coverage and Formulary Placements

The expansion of payer coverage and formulary placements is crucial for INPEFA's market penetration. Lexicon's focus on Integrated Delivery Networks (IDNs) and securing contracts with major Group Purchasing Organizations (GPOs) signals a positive trajectory for the drug's adoption in the upcoming quarters[1].

Financial Performance

Q2 2024 Financial Results

INPEFA generated $1.6 million in net sales for Q2 2024, marking an increase from $0.3 million in the same period of 2023. This growth is driven by the commercialization of INPEFA. However, the company's financial results also show increased research and development (R&D) expenses, rising to $17.6 million, and selling, general, and administrative (SG&A) expenses, which increased to $39.2 million[2][4].

Q3 2024 Financial Results

In the third quarter of 2024, revenues increased to $1.8 million from $0.2 million in the corresponding period of 2023, reflecting increased product revenues from INPEFA sales. R&D expenses rose to $25.8 million, primarily due to investments in Phase 2 and 3 clinical trials, including the SONATA Phase 3 study of sotagliflozin in Hypertrophic Cardiomyopathy (HCM) and the PROGRESS Phase 2b study of LX9211 in Diabetic Peripheral Neuropathic Pain (DPNP)[5].

Net Loss and Cash Position

Despite the revenue growth, Lexicon Pharmaceuticals reported a net loss of $53.4 million in Q2 2024 and $64.8 million in Q3 2024. The company's cash and investments stood at $310.0 million as of June 30, 2024, indicating a strong financial position to support ongoing R&D and commercialization efforts[2][5].

Pipeline Progress and Future Catalysts

Lexicon's pipeline progress is noteworthy, particularly with the resubmission of the New Drug Application (NDA) for ZYNQUISTA in Type 1 Diabetes, which has a PDUFA date of December 20, 2024. The commencement of the SONATA Phase 3 study for sotagliflozin in HCM and the PROGRESS Phase 2b study of LX9211 in DPNP are significant near-term catalysts that could drive future revenue growth and profitability[2].

Expanding Total Addressable Market (TAM) for SGLT Inhibitors

The endorsement of SGLT inhibitors in heart failure treatment by leading medical associations has driven substantial growth in this medication class. The utilization of SGLT inhibitors in heart failure surged by approximately 73% by August 2023, with the overall heart failure market expanding by 40% from 2021 to 2022. This presents a lucrative opportunity exceeding $3 billion and indicates ample room for market expansion for INPEFA[1].

Strategic Maneuvering and Adaptability

Lexicon's strategic shift with Otagiflo (another form of sotagliflozin) demonstrates the company's adaptability. After the FDA rejection of Zynquista for Type 1 Diabetes, Lexicon pivoted towards seeking approval for heart failure treatment in adults with Type 2 Diabetes. This resilience and successful approval enhance INPEFA's credibility in the market[1].

Key Takeaways

• Clinical Benefits: INPEFA offers rapid improvements in heart failure outcomes and significant risk reductions in cardiovascular deaths and heart failure events.
• Market Reception: Despite competition, INPEFA's unique value proposition and growing prescriber base indicate strong market potential.
• Financial Performance: Revenue growth from INPEFA sales, though modest, is increasing, but the company faces significant R&D and SG&A expenses.
• Pipeline Progress: Ongoing clinical trials and the resubmission of the NDA for ZYNQUISTA are key catalysts for future growth.
• Expanding TAM: The growing market for SGLT inhibitors in heart failure presents a significant opportunity for INPEFA.

FAQs

What is INPEFA and how does it work?

INPEFA is an oral inhibitor that targets the SGLT1 and SGLT2 proteins, essential for glucose regulation. It is the first dual SGLT1 and SGLT2 inhibitor, offering rapid improvements in heart failure outcomes and major adverse cardiovascular events.

How has INPEFA performed financially in recent quarters?

In Q2 2024, INPEFA generated $1.6 million in net sales, and in Q3 2024, revenues increased to $1.8 million. Despite revenue growth, Lexicon Pharmaceuticals reported net losses due to increased R&D and SG&A expenses.

What are the key challenges facing INPEFA in the market?

INPEFA faces competition from established SGLT2 inhibitors and investor apprehensions regarding its market reception. However, its unique dual inhibition mechanism and growing prescriber base are positive indicators.

What are the future catalysts for INPEFA's growth?

The resubmission of the NDA for ZYNQUISTA in Type 1 Diabetes, the commencement of the SONATA Phase 3 study for sotagliflozin in HCM, and the PROGRESS Phase 2b study of LX9211 in DPNP are significant near-term catalysts.

How is Lexicon Pharmaceuticals positioned financially to support INPEFA's commercialization?

Lexicon's cash and investments stood at $310.0 million as of June 30, 2024, providing a strong financial position to support ongoing R&D and commercialization efforts.

Sources

1. Seeking Alpha: Lexicon Pharma: Inpefa's Early Clinical Benefits, Rehospitalization Data Unlock Value
2. Stock Titan: Lexicon Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides Business Update
3. BioSpace: Lexicon Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Update
4. Synapse: Lexicon Pharmaceuticals Q2 2024 Financial Results and Business Update
5. BioSpace: Lexicon Pharmaceuticals Reports Third Quarter 2024 Financial Results and Provides Business Update