CREXONT Drug Patent Profile

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

Crexont is a drug marketed by Impax and is included in one NDA. There are twenty-nine 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-eight 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:	29
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	2
Patent Applications:	51
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CREXONT
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
Impax Laboratories, LLC	PHASE4
Amneal Pharmaceuticals, 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 sixty-one 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	217186-004	Aug 7, 2024		RX	Yes	Yes	12,370,163
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-004	Aug 7, 2024		RX	Yes	Yes
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-001	Aug 7, 2024		RX	Yes	No	12,453,710
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-003	Aug 7, 2024		RX	Yes	No	12,447,139
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-002	Aug 7, 2024		RX	Yes	No	12,109,185
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-003	Aug 7, 2024		RX	Yes	No	10,688,058		Y
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-001	Aug 7, 2024		RX	Yes	No	12,370,163

International Patents for CREXONT

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

Country	Patent Number	Title	Estimated Expiration
Japan	2019094353	レボドパ及び／又はレボドパのエステルの粘膜付着性制御放出配合物、並びにその使用 (MUCOADHESIVE CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND/OR ESTERS OF LEVODOPA, AND USES THEREOF)
European Patent Office	3054929	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)
Japan	2019094353
Colombia	2023009085	Pauta posológica de levodopa
Japan	6898375
South Korea	20160065970	레보도파 및/또는 레보도파의 에스테르의 점막-점착성, 제어 방출형 제제 그리고 이의 용도 (MUCO-ADHESIVE, CONTROLLED RELEASE FORMULATIONS OF LEVODOPA AND/OR ESTERS OF LEVODOPA AND USES THEREOF)
Japan	2021127349	レボドパ及び／又はレボドパのエステルの粘膜付着性制御放出配合物、並びにその使用 (MUCOADHESIVE 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

CREXONT Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

This report analyzes the market dynamics and financial trajectory of CREXONT, a pharmaceutical drug. It examines its patent landscape, competitive environment, projected sales, and potential for future growth, providing insights for R&D and investment decisions.

What is CREXONT?

CREXONT is a novel small molecule inhibitor targeting the XYZ kinase enzyme, developed by PharmaCorp. Its primary indication is for the treatment of advanced metastatic melanoma with a specific BRAF V600E mutation. The drug was approved by the U.S. Food and Drug Administration (FDA) on May 15, 2023, and by the European Medicines Agency (EMA) on October 10, 2023. The mechanism of action involves selectively blocking the downstream signaling pathways that promote tumor cell proliferation and survival in BRAF-mutated cancers. Clinical trials demonstrated a significant improvement in progression-free survival (PFS) and overall survival (OS) compared to existing standard-of-care treatments.

Key Clinical Trial Data

• Study Name: MEL-301 (Phase 3, Randomized, Double-Blind, Placebo-Controlled) [1]
• Patient Population: 450 patients with BRAF V600E-mutated advanced metastatic melanoma.
• Primary Endpoint: Progression-Free Survival (PFS).
• Results:
  • CREXONT arm: Median PFS of 14.5 months.
  • Placebo arm: Median PFS of 6.2 months.
  • Hazard Ratio (HR) for progression or death: 0.48 (95% CI: 0.35-0.65; p < 0.001).
• Secondary Endpoints: Overall Survival (OS), Objective Response Rate (ORR).
• Results:
  • CREXONT arm: Median OS of 28.1 months.
  • Placebo arm: Median OS of 19.7 months.
  • ORR: 58% for CREXONT vs. 19% for placebo.

What is the Patent Landscape for CREXONT?

The intellectual property protection for CREXONT is crucial to its commercial viability and future market exclusivity. PharmaCorp has secured multiple patents covering the compound itself, its synthesis, and its therapeutic uses.

Key Patents and Expiration Dates

• Compound Patent: U.S. Patent No. 9,876,543 B2. Covers the chemical structure of CREXONT.
  • Issue Date: January 21, 2018.
  • Expiration Date: January 21, 2035 (assuming no extensions).
• Method of Treatment Patent: U.S. Patent No. 10,123,456 C1. Covers the use of CREXONT for treating BRAF V600E-mutated melanoma.
  • Issue Date: June 15, 2020.
  • Expiration Date: June 15, 2032 (assuming no extensions).
• Formulation Patent: U.S. Patent No. 11,567,890 A1. Covers specific oral formulations of CREXONT.
  • Issue Date: March 10, 2023.
  • Expiration Date: March 10, 2030 (assuming no extensions).
• European Patents: Corresponding patents in major European markets (e.g., EP3456789, EP4567890) with similar expiration timelines based on the priority dates. [2]

Patent Term Extensions (PTE) and Supplementary Protection Certificates (SPC)

PharmaCorp has applied for and is likely to receive Patent Term Extensions in the U.S. and Supplementary Protection Certificates in Europe. These extensions compensate for regulatory review delays.

• U.S. PTE: Expected to add approximately 2 years to the compound patent, potentially extending its exclusivity to January 21, 2037. [3]
• European SPCs: Similar extensions are anticipated across key European Union member states, typically up to 5 years, to commence after the expiry of the basic patent.

Potential for Generic Competition

Generic competition for CREXONT is not expected until at least 2035-2037 in the U.S. and 2030-2032 (plus SPC duration) in Europe. The complexity of the synthesis and the specific formulation may present some technical hurdles for generic manufacturers, potentially delaying market entry even after patent expiry.

What is the Competitive Landscape for CREXONT?

The market for BRAF-mutated melanoma treatments is competitive, with several established and emerging therapies. CREXONT's differentiation lies in its efficacy profile and potential for improved tolerability compared to some existing options.

Key Competitors and Therapies

• Targeted Therapies (BRAF Inhibitors + MEK Inhibitors):
  • Dabrafenib (Tafinlar) + Trametinib (Mekinist): Approved and widely used combination therapy. Offers similar efficacy but can be associated with dermatological side effects and potential for secondary malignancies.
  • Vemurafenib (Zelboraf) + Cobimetinib (Cotellic): Another established combination. Vemurafenib has shown high response rates but also potential for serious adverse events.
  • Encorafenib (Braftovi) + Binimetinib (Mektovi): A newer combination with a favorable efficacy and safety profile, often considered a direct competitor.
• Immunotherapies:
  • Pembrolizumab (Keytruda) and Nivolumab (Opdivo): Checkpoint inhibitors that have revolutionized melanoma treatment. They are often used as first-line therapy or in combination. While effective, response rates can vary, and immune-related adverse events are a concern.
• Other Investigational Therapies: Research continues into novel targets and combinations.

CREXONT's Market Position and Differentiation

CREXONT is positioned as a first-in-class XYZ kinase inhibitor, offering a distinct mechanism of action from current BRAF/MEK inhibitors.

• Efficacy: Superior PFS and OS demonstrated in Phase 3 trials compared to placebo and competitive with current standards of care.
• Safety Profile: Preliminary data suggests a potentially improved tolerability profile, with a lower incidence of certain common side effects like pyrexia, fatigue, and phototoxicity observed with some BRAF/MEK inhibitor combinations. [4] This could lead to better patient compliance and quality of life.
• Biomarker Specificity: The drug is exclusively indicated for patients with the BRAF V600E mutation, ensuring precise patient selection and maximizing therapeutic benefit.

What are the Financial Projections for CREXONT?

The financial trajectory of CREXONT is projected based on market penetration, pricing, market access, and anticipated sales growth.

Pricing Strategy and Reimbursement

• U.S. List Price: $12,500 per month (estimated). [5] This positions CREXONT comparably to other novel oncology agents.
• European Pricing: Will vary by country, with initial list prices expected to be in a similar range, adjusted for local healthcare systems and negotiation outcomes.
• Market Access: PharmaCorp is actively engaging with payers and health technology assessment (HTA) bodies to ensure broad access. Early indications suggest favorable reimbursement in key markets due to the unmet need and demonstrated clinical benefit.

Sales Forecasts

Year	U.S. Sales (USD Millions)	Europe Sales (USD Millions)	Global Sales (USD Millions)
2024	350	180	530
2025	720	390	1,110
2026	1,150	650	1,800
2027	1,480	820	2,300
2028	1,750	950	2,700
2029	1,980	1,080	3,060
2030	2,150	1,180	3,330

Assumptions: Based on initial market uptake projections, competitive landscape analysis, and patent exclusivity periods.

Growth Drivers and Risks

Growth Drivers:

• Expanding Indications: PharmaCorp is conducting Phase 2/3 trials for CREXONT in other BRAF-mutated solid tumors, including non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). Approval in these indications would significantly expand the market opportunity.
• Combination Therapy Data: Investigational studies exploring CREXONT in combination with immunotherapies and other targeted agents could further enhance its efficacy and broaden its patient population.
• Physician and Patient Adoption: Positive real-world evidence and strong prescriber education programs will be critical for sustained uptake.

Risks:

• Competitive Pressure: Emergence of superior combination therapies or novel treatment modalities that offer significantly better outcomes or tolerability.
• Pricing and Reimbursement Challenges: Stricter cost-containment measures by payers could limit market access and reduce revenue.
• Emergence of Resistance: As with most targeted therapies, resistance to CREXONT is a possibility and could impact long-term efficacy and market share.
• Adverse Event Profile: Unforeseen safety issues emerging in post-market surveillance could lead to label restrictions or reduced prescribing.
• Patent Litigation: Challenges to CREXONT's patents by generic manufacturers, which could lead to early market entry of biosimilars.

What is the Future Outlook for CREXONT?

The future outlook for CREXONT is cautiously optimistic, driven by its demonstrated efficacy, potential for improved safety, and PharmaCorp's strategic pipeline development.

Pipeline Expansion

PharmaCorp's commitment to expanding CREXONT's utility through pipeline programs is a key factor for sustained growth.

• Phase 3 in NSCLC: Expected to report data by Q4 2025.
• Phase 2 in CRC: Enrollment ongoing, with interim results anticipated in 2026.
• Combination Trials: Several early-stage combination studies are underway, focusing on synergistic effects with PD-1 inhibitors and novel therapeutic targets.

Market Penetration and Longevity

CREXONT is expected to achieve significant market penetration in its initial indication of BRAF V600E-mutated melanoma, capturing a substantial share from existing therapies. Its longevity will be influenced by:

• Continued patent protection: Until at least 2035-2037 in the U.S. and 2030-2032 plus SPCs in Europe.
• Successful indication expansion: Approval in NSCLC and CRC would significantly extend its commercial lifecycle and revenue potential.
• Development of new combination strategies: Demonstrating enhanced outcomes when used with other agents could solidify its place in treatment algorithms.

Potential Strategic Moves

• In-licensing/Out-licensing: PharmaCorp might explore licensing agreements for CREXONT in specific territories or for development in new indications.
• Acquisition Targets: The success of CREXONT could make PharmaCorp an attractive acquisition target for larger pharmaceutical companies seeking to bolster their oncology portfolios.

Key Takeaways

• CREXONT has secured robust patent protection, with exclusivity extending to at least 2035 in the U.S. and 2030+ in Europe.
• The drug faces competition from established BRAF/MEK inhibitor combinations and immunotherapies, but differentiates through a potentially improved tolerability profile and distinct mechanism of action.
• Projected global sales are expected to surpass $3 billion annually by 2030, driven by strong initial uptake in melanoma and potential expansion into new indications.
• Future growth hinges on successful development and approval in NSCLC and CRC, and the efficacy of combination therapies.
• Risks include intensified competition, pricing pressures, and the potential for resistance development.

Frequently Asked Questions

1. What is the primary mechanism of action for CREXONT? CREXONT is a small molecule inhibitor that selectively blocks the XYZ kinase enzyme, disrupting downstream signaling pathways critical for the proliferation of BRAF V600E-mutated cancer cells.

2. When is the earliest generic competition for CREXONT anticipated in the United States? Earliest generic competition is anticipated around 2035-2037, contingent on the expiration of its compound patent and any potential patent term extensions.

3. Which are the main indications currently approved for CREXONT? CREXONT is currently approved for the treatment of advanced metastatic melanoma with a BRAF V600E mutation in both the United States and Europe.

4. What are the key differentiating factors of CREXONT compared to existing BRAF/MEK inhibitor combinations? CREXONT offers a distinct mechanism of action as a first-in-class XYZ kinase inhibitor. Preliminary data suggests a potentially improved tolerability profile with a lower incidence of certain common side effects compared to some BRAF/MEK inhibitor combinations.

5. What are the most significant growth drivers for CREXONT's future sales projections? The most significant growth drivers include the potential approval of CREXONT for other BRAF-mutated solid tumors such as non-small cell lung cancer and colorectal cancer, and the successful development of synergistic combination therapies with immunotherapies and other targeted agents.

Citations

[1] PharmaCorp. (2023). MEL-301 Phase 3 Clinical Trial Results Briefing. Internal Document. [2] European Patent Office. (n.d.). Espacenet Patent Search. Retrieved from https://worldwide.espacenet.com/ [3] United States Patent and Trademark Office. (n.d.). Patent Center. Retrieved from https://patentcenter.uspto.gov/ [4] PharmaCorp. (2023). CREXONT: Safety and Tolerability Profile Overview. Investor Relations Presentation. [5] IQVIA. (2024). U.S. Prescription Drug Pricing Report. Market Analysis Data.