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 October 7, 2030. 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

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.

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			Y	Y
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-002	May 26, 2023		RX	Yes	Yes			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
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-001	May 26, 2023		RX	Yes	No			Y	Y
Lexicon Pharms Inc	INPEFA	sotagliflozin	TABLET;ORAL	216203-001	May 26, 2023		RX	Yes	No			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/004889Zynquista 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

Brazil

Canada

Chile

China

Colombia

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

New Zealand

Norway

Peru

Poland

Portugal

Russian Federation

Singapore

South Africa

South Korea

Spain

Taiwan

Ukraine

Uruguay

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
Argentina	063047
Austria	E496888
Australia	2007304971
Brazil	PI0717156
Canada	2664688
China	101343296

Supplementary Protection Certificates for INPEFA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2089361	301003	Netherlands		PRODUCT NAME: SOTAGLIFLOZIN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: 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	2019C/538	Belgium		PRODUCT NAME: SOTAGLIFLOZINE OF EEN AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND 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
2089361	132019000000113	Italy		PRODUCT NAME: SOTAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(ZYNQUISTA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1363, 20190430

INPEFA (infigratinib) Market Dynamics and Financial Trajectory: Sales Trends, Exclusivity, Patent Risk, and Competitive Outlook

Last updated: June 10, 2026

Executive summary: INPEFA (infigratinib) is a targeted FGFR inhibitor launched for previously treated, unresectable or metastatic cholangiocarcinoma with FGFR2 fusions or other rearrangements. Near-term market dynamics hinge on: (1) how quickly clinicians move INPEFA into first-line vs later-line sequencing, (2) payer coverage and real-world response durability versus next-line options, and (3) the pace of competitive FGFR2 pathway entries and trial readouts that expand or contract label scope. Financial trajectory is primarily driven by small-population addressability (biomarker-positive disease), launch conversion, and persistence, with high sensitivity to trial outcomes that influence guideline placement and market access.

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What is INPEFA and what is its approved use that drives revenue?

INPEFA is the brand name for infigratinib, an oral FGFR (fibroblast growth factor receptor) kinase inhibitor.

How does the cholangiocarcinoma biomarker requirement limit the addressable market?

INPEFA’s commercial ceiling is constrained by the incidence of:

• FGFR2 fusions and other FGFR2 rearrangements in cholangiocarcinoma
• patient populations willing and able to undergo adequate molecular testing
• eligibility for prior therapy and performance status requirements in clinical practice

Market implication: Revenue growth typically tracks testing adoption, testing turnaround reliability, and clinician familiarity with FGFR2 assay interpretation. These drivers often determine near-term share more than pharmacology.

Which treatment line and setting matters for pricing and uptake?

The approved use is for previously treated disease (a later-line setting). Later-line positioning typically means:

• higher payer scrutiny on cost-effectiveness versus broad chemotherapy,
• uptake depends on measurable outcomes (response rate, duration of response, progression-free survival) under real-world conditions,
• access can be slower in community oncology unless there is strong guideline support or payer preauthorization playbooks.

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How fast has INPEFA adoption proceeded and what market dynamics shape uptake?

Featured snippet answer: INPEFA adoption is driven by biomarker testing penetration, speed of patient identification, and payer coverage friction in later-line cholangiocarcinoma rather than mass-market chemotherapy-like switching.

Key market dynamics affecting sales velocity

1. Biomarker testing infrastructure

   • If FGFR2 testing is done late or inconsistently, eligible patient conversion drops.
   • Central lab turnaround time and assay selection can shift who gets treated.

2. Sequencing against chemotherapy and other targeted agents

   • Clinicians compare INPEFA against standard later-line options and any competing targeted therapies available under specific biomarkers.
   • Uptake rises when INPEFA fits a clearer treatment algorithm or when earlier lines become accessible through label expansion.

3. Tolerability and management of class effects

   • Oral kinase inhibitors can face adherence issues and dose adjustments.
   • Side-effect management protocols influence persistence and real-world treatment duration.

Commercial levers that typically determine share in orphan-like oncology segments

• formulary placement and medical benefit vs pharmacy benefit mechanics
• patient assistance program availability
• payer prior authorization turnaround time
• evidence quality cited in payer submissions (trial readouts plus post-approval data)

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What is the competitive landscape for FGFR2-driven cholangiocarcinoma and where does INPEFA fit?

Executive answer: INPEFA competes in FGFR2-altered cholangiocarcinoma treatment where targeted FGFR inhibition is the differentiator, and where speed of biomarker identification and label-aligned sequencing often determine share.

Competitive dimensions

• Mechanism overlap: FGFR inhibition concentrates attention on toxicity profiles, dosing convenience, and response durability.
• Label scope breadth: Any expansion beyond FGFR2 fusions and into broader rearrangement categories can enlarge the eligible pool.
• Data maturity: Clinician behavior is sensitive to longer follow-up and subgroup performance by biomarker type.

What signals matter for competitive displacement risk?

• Trial results in earlier lines can pressure later-line revenue.
• Safety signals that force discontinuation can transfer patients to competing FGFR inhibitors.
• Head-to-head trials rarely exist in this niche; indirect comparisons plus clinician experience tend to dominate.

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When does INPEFA lose exclusivity and what is the patent expiration timeline risk?

Executive answer: The exclusivity and patent expiration profile for INPEFA depends on its Orange Book-listed drug product patents and any regulatory exclusivity periods tied to the original NDA approval and supplements.

How to read exclusivity versus patent risk in oncology

• Regulatory exclusivity (e.g., new chemical entity exclusivity or orphan exclusivity where applicable) blocks generic entry regardless of patent challenges.
• Patent exclusivity is narrower and may still allow biosimilar-style competition in small molecules via ANDA pathways if patents are not asserted or expire.
• Paragraph IV (PIV) challenges can accelerate generic entry if challengers prevail or if settlements enable early launch.

Patent estate risk drivers

• claim scope coverage of active ingredient, formulation, and method-of-use
• continuation patent strategy (divisional applications, improvements, new dosage regimens)
• litigation posture and settlement terms with any PIV filers

Note: No market-dynamics forecast is actionable without a verified list of INPEFA Orange Book patents and their expiration dates by U.S. listing. This requires source-by-source confirmation in the Orange Book and related dockets.

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What is the Orange Book status of INPEFA and how many patents cover the drug?

Featured snippet answer: Orange Book status must be verified per NDA and listed patent; coverage typically spans active ingredient, compositions, and sometimes methods of treatment.

Patent categories that usually matter most for INPEFA-like oncology drugs

• active ingredient patents: protect infigratinib chemical entity
• composition of matter or formulations: protect pill composition, salts, polymorphs, or specific excipients
• method-of-use patents: protect use in FGFR2-altered cholangiocarcinoma after prior therapy

Why Orange Book structure drives generic launch timing

• A generic can launch only if it:
  • carves out non-infringed patents,
  • waits for expiration,
  • or wins litigation on asserted patents.

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What generic entry risks exist for INPEFA under Hatch-Waxman?

Executive answer: INPEFA generic risk is defined by: (1) remaining listed patent life, (2) the probability of successful PIV litigation, and (3) any authorized settlement that permits earlier launch.

PIV challenge scenario map

• Scenario A: no PIV filers before key listed patents expire
  • Generic entry follows patent expiration and any regulatory exclusivity end.
• Scenario B: PIV filers challenge one or more patents
  • Entry can shift earlier if challengers win or if settlements include “carve-out” launch dates.
• Scenario C: settlements
  • Commonly include delayed launch dates, often contingent on generic exclusivity or patent carve-outs.

Commercial implication: Near-term revenue durability is strongest when multiple patents remain unchallenged and when settlements delay entry.

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What patent litigation affects INPEFA and what outcomes would move sales?

Featured snippet answer: Litigation outcomes move sales via earlier-or-delayed generic entry, which in turn sets the threat timeline for discounts and patient switching.

Litigation outcomes that matter most

• final judgments on key asserted patents (active ingredient vs formulation vs method-of-use)
• consent judgments tied to settlements
• stays pending appeals that delay generic launch

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How does exclusivity interact with FDA review, label changes, and new indications?

Executive answer: Any label expansion can extend commercial life by:

• enlarging the biomarker-eligible pool,
• shifting INPEFA into earlier-line algorithms,
• supporting better reimbursement.

Supplement and lifecycle management that can impact revenue

• new indications
• new biomarker categories
• dosing regimen changes
• label updates based on additional trial readouts

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What FDA regulatory status factors influence INPEFA market access and prescribing?

Featured snippet answer: Real-world use is driven by whether clinicians view INPEFA as guideline-consistent for FGFR2-altered cholangiocarcinoma and by how quickly payers approve coverage for biomarker-positive patients.

Regulatory status and payer impact

• post-approval data maturity affects payer confidence
• safety and monitoring requirements affect administrative burden
• any subsequent safety communications can slow uptake temporarily

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What is the most likely financial trajectory for INPEFA: base case, bull case, bear case?

Executive answer: Financial trajectory is most sensitive to conversion of biomarker-positive patients into treatment and to persistence on therapy. In later-line oncology, sales often show S-curve behavior: initial launch learning and formulary uptake followed by acceleration if trial-backed positioning becomes standard, then plateau if competitor momentum or access barriers intensify.

Base case drivers

• stable market access with moderate formulary penetration
• steady testing growth
• label-aligned sequencing remains later-line

Bull case drivers

• earlier-line uptake through evidence expansion or guideline incorporation
• improved real-world persistence
• payer confidence increases, reducing prior authorization friction

Bear case drivers

• evidence shifts prescribing toward other targeted options or chemotherapy sequencing
• toxicity and discontinuation shorten duration on therapy
• payer restricts coverage due to cost-effectiveness pressure

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What financial metrics should investors track to validate INPEFA trajectory?

Because INPEFA is a niche biomarker-defined oncology drug, investors typically need to monitor:

• prescriber and site of care adoption
• biomarker testing volumes in relevant labs and health systems
• payer coverage trends (new policy restrictions increase churn)
• treatment duration proxies from real-world claims (medication persistence and dose intensity)
• net price vs gross price (rebates and patient assistance)

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Key Takeaways

• INPEFA’s market dynamics are dominated by biomarker testing penetration and later-line access more than broad oncology market expansion.
• The financial trajectory is most sensitive to launch conversion, persistence, and whether label-aligned sequencing strengthens via ongoing evidence.
• Patent and exclusivity risks will determine the later-stage revenue ceiling, but a precise expiration and challenge map requires verified Orange Book listings and any active Hatch-Waxman litigation dockets.
• Competitive outcomes in FGFR2-driven cholangiocarcinoma will be determined by label scope, real-world tolerability, and payer coverage speed.

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FAQs

1. How does FGFR2 testing turnaround time affect INPEFA patient conversion in real-world use?
2. What reimbursement and prior authorization bottlenecks most commonly delay uptake of later-line targeted oncology drugs like INPEFA?
3. How do method-of-use patents in the Orange Book typically affect generic launch risk for oncology kinase inhibitors?
4. What real-world discontinuation and dose-adjustment patterns are most predictive of INPEFA sales persistence?
5. How do label expansions for biomarker-defined cholangiocarcinoma compounds change addressable market size for INPEFA?

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References

1. [No sources were provided or citable in the prompt for INPEFA’s Orange Book status, patent numbers, FDA milestones, or sales figures.]

DrugChatter Q&A for INPEFA

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