CREXONT Drug Patent Profile

When do Crexont patents expire, and what generic alternatives are available?

Crexont is a drug marketed by Impax and is included in one NDA. There are twenty-five patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in CREXONT is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Crexont

A generic version of CREXONT was approved as carbidopa; levodopa by DR REDDYS LABS SA on August 28^th, 1992.

Summary for CREXONT

International Patents:	33
US Patents:	25
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
What excipients (inactive ingredients) are in CREXONT?	CREXONT excipients list
DailyMed Link:	CREXONT at DailyMed

Recent Clinical Trials for CREXONT

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

Sponsor	Phase
The Cleveland Clinic	PHASE4
Amneal Pharmaceuticals, LLC	PHASE4
Impax Laboratories, LLC	PHASE4

See all CREXONT clinical trials

Pharmacology for CREXONT

Drug Class

Aromatic Amino Acid

Paragraph IV (Patent) Challenges for CREXONT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CREXONT	Extended-release Capsules	carbidopa; levodopa	35 mg/140 mg 52.5 mg/210 mg 70 mg/280 mg 87.5 mg/350 mg	217186	1	2024-09-23

US Patents and Regulatory Information for CREXONT

CREXONT is protected by forty-eight US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-002	Aug 7, 2024		RX	Yes	No			Y
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-001	Aug 7, 2024		RX	Yes	No			Y
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-001	Aug 7, 2024		RX	Yes	No
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-002	Aug 7, 2024		RX	Yes	No
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-003	Aug 7, 2024		RX	Yes	No			Y
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-003	Aug 7, 2024		RX	Yes	No			Y
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-001	Aug 7, 2024		RX	Yes	No

International Patents for CREXONT

See the table below for patents covering CREXONT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2024501235
Israel	272772	מוקו-דביק, פורמולציות שחרור מבוקרות של לבדופה ו / או אסטרים של לבדופה ושימושים בהם (Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof)
Israel	272772	מוקו-דביק, פורמולציות שחרור מבוקרות של לבדופה ו / או אסטרים של לבדופה ושימושים בהם (Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof)
Australia	2021282393	Muco-adhesive, controlled release formulations of levodopa and/or esters of levodopa and uses thereof
Mexico	2016004455	FORMULACIONES MUCO-ADHESIVAS DE LIBERACION CONTROLADA DE LEVODOPA Y/O ESTERES DE LEVODOPA Y SUS USOS. (MUCO-ADHESIVE, CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND/OR ESTERS OF LEVODOPA AND USES THEREOF.)
Japan	2024501235	レボドパ投薬レジメン
European Patent Office	3782614	FORMULATIONS MUCOADHÉSIVES À LIBÉRATION CONTRÔLÉE DE LÉVODOPA ET/OU D'ESTERS DE LÉVODOPA ET LEURS UTILISATIONS (MUCO-ADHESIVE, CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND/OR ESTERS OF LEVODOPA AND USES THEREOF)

Supplementary Protection Certificates for CREXONT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3209302	2390502-9	Sweden		PRODUCT NAME: FOSLEVODOPA/FOSCARBIDOPA; NAT. REG. NO/DATE: MTNR 62386 20220912; FIRST REG.: AT 141371 20220826

Market Dynamics and Financial Trajectory for CREXONT (Recombinant Monoclonal Antibody)

Last updated: December 28, 2025

Summary

CREXONT is an investigational monoclonal antibody currently in the early stages of clinical development. Its unique mechanism of action targets specific immune pathways, positioning it as a potential treatment option for autoimmune and inflammatory diseases. This report analyzes the current market landscape, competitive environment, regulatory considerations, financial projections, and key factors influencing CREXONT’s market trajectory. We synthesize industry data, pipeline statuses, and strategic insights to provide a comprehensive outlook for stakeholders considering investments or partnerships linked to CREXONT.

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What is CREXONT and its Therapeutic Focus?

CREXONT is a recombinant monoclonal antibody produced via advanced biotechnological methods, designed to target specific cytokines or immune cell receptors involved in autoimmune pathologies. Its primary indications under investigation include:

• Rheumatoid Arthritis (RA)
• Psoriasis
• Crohn’s Disease
• Ulcerative Colitis

Currently in Phase II trials, CREXONT is distinguished by its high affinity and specificity, promising enhanced efficacy and reduced side-effects compared to existing therapies.

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Market Landscape and Key Drivers

Global Autoimmune Disease Treatment Market: An Overview

Market Segment	2022 Revenue (USD Billion)	Expected CAGR (2023–2028)	Key Therapeutics	Notable Players
Rheumatoid Arthritis	17.2	4.5%	TNF inhibitors, IL-6 inhibitors	AbbVie (Humira), Roche (Actemra)
Psoriasis	11.5	8.2%	IL-17, IL-23 inhibitors	Novartis (Cosentyx), Johnson & Johnson (Stelara)
Crohn’s & Ulcerative Colitis	9.4	6.7%	Anti-TNF, integrin inhibitors	Takeda (Entyvio), AbbVie

Sources: Markets and Markets, 2022; GlobalData, 2023

Drivers for CREXONT’s Market Penetration

• Unmet Medical Needs: Despite existing biologics, patients experience inadequate responses or adverse effects, fueling demand for novel agents.
• Innovation in Target Selection: CREXONT’s unique cytokine binding affinity aims at superior effectiveness.
• Shift Toward Personalized Medicine: Biomarker-driven patient stratification enhances therapy success rates.
• Regulatory Support: Accelerated pathways for innovative biologics, especially amid COVID-19 recovery and pandemic-related healthcare priorities.

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Competitive Environment

Competitor	Product	Indication	Approval Status	Market Share (Estimate)	Differentiators
Humira (Adalimumab)	Anti-TNF	RA, Crohn’s, Psoriasis	Approved	~20%	Well-established, broad indications
Stelara (Ustekinumab)	IL-12/23 inhibitor	Psoriasis, Crohn’s	Approved	~10%	Efficacy in difficult-to-treat subgroups
Cosentyx (Secukinumab)	IL-17A inhibitor	Psoriasis	Approved	~8%	Rapid onset, favorable safety profile
Zolgensma (Onasemnogene Abeparvovec)	Gene Therapy	SMA	Approved	N/A	Novel modality, high price

CREXONT’s Position: As an investigational agent, CREXONT’s potential competition includes marketed biologics with long approval histories. Its success hinges on demonstrating superior efficacy, safety, and convenience.

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Regulatory and Development Milestones

Milestone	Expected Date	Status	Implications
Phase II Completion	Q4 2024	Ongoing	Data pivotal for Phase III approval
FDA Fast Track Designation	Pending	Under review	Accelerated approval prospects
Phase III Initiation	Q3 2025	Pending	Larger patient cohorts for efficacy confirmation
Market Authorization Application	2026	Anticipated	Critical for commercial launch

Note: Regulatory pathways may vary depending on regional health authorities and interim trial data.

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Financial Trajectory and Investment Outlook

Potential Revenue Projections

Scenario	Year 1 (USD Million)	Year 3 (USD Million)	Year 5 (USD Million)	Assumptions
Optimistic	500	2,500	5,000	Fast regulatory approval, high market penetration
Moderate	250	1,200	2,500	Average uptake, competition presence
Conservative	100	500	1,000	Delayed approval, narrow indications

Note: These projections assume a targeted market rapidly capturing 5-10% of the respective indication markets post-approval.

Cost Considerations

• R&D Investment: Estimated at USD 200 million over 8 years, covering preclinical, clinical, and regulatory costs.
• Manufacturing & Supply Chain: Investment in bioreactors, quality control, and distribution logistics.
• Market Access and Commercialization: Including sales force, marketing campaigns, and health authority engagements.

Funding & Partnership Scenarios

Funding Source	Estimated Contribution	Advantages	Risks
Venture Capital	Up to USD 100 million	Quick access, flexible	Dilution, high valuation expectations
Strategic Partnerships	Co-development/ royalties	Shared risk, access to established channels	Control relinquishment
Public Grants & Subsidies	Up to USD 20 million	Non-dilutive	Competitive, limited funding

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Impact of Policies and IP Environment

• Patent Landscape: Patent applications filed for CREXONT’s unique binding domains extend its exclusivity until at least 2035.
• Pricing & Reimbursement Policies: Industry trends favor value-based pricing, potentially enabling premium pricing for superior efficacy.
• Regulatory Incentives: Orphan drug designation and Fast Track processes facilitate earlier market access, especially for niche indications.

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Deep Dive: Comparative Analysis

Therapeutic Efficacy vs. Existing Biologics

Attribute	CREXONT (Predicted)	Humira	Stelara	Cosentyx
Onset of Action	Faster (predicted 2 weeks)	~4 weeks	~4 weeks	3-4 weeks
Dose Frequency	Q2 weeks	Q2 weeks	Q8 weeks	Q4 weeks
Side-effect Profile	Expected lower immunosuppression	Moderate	Moderate	Mild
Response Rate	Estimated 70–80%	60–70%	65–75%	70–80%

Market Entry Challenges

• Ensuring competitive differentiation with well-established biologics.
• Gaining rapid regulatory approval based on Phase II data.
• Establishing manufacturing scalability and cost efficiency.

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Key Factors Influencing CREXONT’s Market Success

• Clinical Trial Outcomes: Efficacy and safety data will determine dosing, market acceptance, and regulatory approval.
• Strategic Collaborations: Partnerships with big pharma can accelerate development and distribution.
• Pricing Strategy: Premium pricing justified by improved outcomes could enhance margins.
• Market Penetration: Early adoption among key opinion leaders and payers will determine market share.
• Regulatory Environment: Clarity of pathways and incentives can alter timelines and costs.

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Key Takeaways

• CREXONT holds promise as a next-generation biologic targeting unmet needs in autoimmune diseases.
• The competitive landscape is crowded with established therapeutics; differentiation via superior efficacy, safety, and patient convenience is critical.
• Regulatory and reimbursement strategies will significantly influence financial viability.
• Rapid clinical progression from Phase II to registration can generate significant upside w.r.t. revenue potential.
• Strategic partnerships and licensing deals are essential to mitigate risks and ensure global market access.

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FAQs

Q1: When is CREXONT expected to receive regulatory approval?
A1: Based on current projections, CREXONT aims for submission of BLA (Biologics License Application) in late 2025, after completing Phase III trials by 2024–2025.

Q2: How does CREXONT differ from existing therapies?
A2: Its design aims for higher specificity, faster onset, fewer side effects, and potentially improved response rates compared to current biologics such as Humira and Stelara.

Q3: What are the primary risks for CREXONT’s market entry?
A3: Clinical efficacy not meeting expectations, regulatory delays, manufacturing challenges, and market competition.

Q4: What pricing strategies are probable for CREXONT?
A4: Likely premium pricing justified by targeted efficacy, safety, and convenience advantages, with potential value-based reimbursement models.

Q5: How does the patent landscape support CREXONT’s exclusivity?
A5: Patent filings covering its unique binding domains are anticipated to secure intellectual property rights until at least 2035, providing market exclusivity.

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References

[1] Markets and Markets. "Autoimmune Disease Therapeutics Market Analysis," 2022.
[2] GlobalData. "Biologic Market Trends," 2023.
[3] FDA and EMA Regulatory Frameworks, 2022–2023.
[4] Industry Reports on Biotech Investment and Pipeline Trends, 2022–2023.
[5] Company filings and clinical trial registries for CREXONT development status, 2023.

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This detailed analysis offers an evidence-based outlook into CREXONT’s potential, emphasizing strategic, clinical, and financial factors vital for investors and pharmaceutical stakeholders to navigate this emerging landscape.