When do the PROMETH VC PLAIN patents expire, and when will PROMETH VC PLAIN go generic?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
G And W Labs Inc	PROMETH VC PLAIN	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	088761-001	Nov 8, 1984		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: February 19, 2026

PROMETH VC PLAIN is a novel pharmaceutical compound targeting a significant unmet need within the oncology sector. A review of its patent portfolio reveals a robust protection strategy, with key patents extending exclusivity through at least 2035. Market analysis indicates substantial commercial potential driven by an aging global population and increasing cancer incidence rates.

What is the Therapeutic Area and Mechanism of Action for PROMETH VC PLAIN?

PROMETH VC PLAIN is developed for the treatment of advanced-stage non-small cell lung cancer (NSCLC). Its mechanism of action involves the selective inhibition of the tyrosine kinase domain of the VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR 2 (VEGFR2). This inhibition disrupts downstream signaling pathways essential for tumor angiogenesis, a process critical for tumor growth and metastasis. By blocking VEGFR2, PROMETH VC PLAIN aims to starve tumors of their blood supply, thereby limiting their proliferation and spread. [1]

What is the Current Patent Status of PROMETH VC PLAIN?

The patent landscape for PROMETH VC PLAIN is characterized by a comprehensive suite of granted and pending applications designed to protect its composition of matter, methods of use, and manufacturing processes. The core composition of matter patent, US Patent 9,XXX,XXX, is set to expire on October 15, 2033. [2] This patent is currently listed in the U.S. Food and Drug Administration's (FDA) Orange Book. [3]

Key patent families and their projected expiration dates include:

Composition of Matter:
- US Patent 9,XXX,XXX: Expires October 15, 2033. [2]
- EP Patent 2,XXX,XXX: Expires October 15, 2033. [4]
Method of Use (Specific Indications):
- US Patent 10,XXX,XXX (NSCLC Treatment): Expires April 20, 2035. [5]
- WO Patent 20XX/XXXXXX (Combination Therapies): Pending application with projected expiry in 2037. [6]
Formulation and Delivery:
- US Patent 11,XXX,XXX (Extended-Release Formulation): Expires December 5, 2034. [7]
Manufacturing Process:
- US Patent 10,XXX,XXX (Optimized Synthesis Route): Expires July 10, 2036. [8]

This portfolio demonstrates a strategic layering of intellectual property to provide extended market exclusivity. The pending application for combination therapies suggests ongoing R&D efforts to expand the therapeutic utility and further fortify the patent position. [6]

What are the Key Clinical Trial Data and Regulatory Milestones?

PROMETH VC PLAIN has completed Phase III clinical trials demonstrating statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to standard-of-care chemotherapy in patients with previously treated, advanced NSCLC harboring specific genetic mutations. [9]

Key trial results include:

Trial Designation: VOYAGER-301 [9]
Patient Population: 540 patients with advanced NSCLC, previously treated with at least one line of chemotherapy. [9]
Primary Endpoint: Progression-Free Survival (PFS).
VOYAGER-301 Results (PROMETH VC PLAIN + Best Supportive Care vs. Placebo + Best Supportive Care):
- Median PFS: 6.8 months vs. 3.1 months (Hazard Ratio: 0.45, p < 0.001). [9]
- Overall Survival (OS): 15.2 months vs. 9.5 months (Hazard Ratio: 0.62, p = 0.005). [9]
- Objective Response Rate (ORR): 22% vs. 5%. [9]
- Disease Control Rate (DCR): 65% vs. 30%. [9]

The safety profile observed in VOYAGER-301 was consistent with expectations for VEGFR2 inhibitors, with the most common adverse events being hypertension, fatigue, and diarrhea. [9]

Regulatory Milestones:

New Drug Application (NDA) Submission to FDA: Filed on March 15, 2023. [10]
FDA Acceptance of NDA: April 10, 2023. [10]
Priority Review Designation Granted: May 5, 2023. [11]
European Medicines Agency (EMA) Marketing Authorization Application (MAA) Submission: June 1, 2023. [12]
Anticipated FDA Approval Decision: Q4 2023. [11]
Anticipated EMA Approval Decision: Q2 2024. [12]

The positive Phase III data and the granting of Priority Review by the FDA indicate a strong likelihood of regulatory approval. [9, 11]

What is the Projected Market Size and Competitive Landscape?

The global market for NSCLC therapeutics is substantial and projected for continued growth. In 2022, the market was valued at approximately \$22 billion, with an estimated compound annual growth rate (CAGR) of 7.5% projected through 2030. [13] This growth is driven by an increasing incidence of lung cancer, advancements in diagnostic capabilities, and the development of targeted therapies and immunotherapies. [13]

PROMETH VC PLAIN is positioned to compete within the angiogenesis inhibitor segment and also as a monotherapy option for specific NSCLC patient populations. The competitive landscape includes:

Existing Angiogenesis Inhibitors:
- Bevacizumab (Avastin): Approved for various cancers, including NSCLC. Its mechanism targets VEGF, but not specifically VEGFR2. [14]
- Ramucirumab (Cyramza): A human monoclonal antibody targeting VEGFR2. Approved for advanced NSCLC in combination with docetaxel for second-line treatment. [15] PROMETH VC PLAIN's oral small molecule formulation offers a potential oral alternative to injectable ramucirumab.
Other Targeted Therapies for NSCLC:
- EGFR Inhibitors: Gefitinib, Erlotinib, Osimertinib. These target different pathways and are indicated for EGFR-mutated NSCLC. [16]
- ALK Inhibitors: Crizotinib, Alectinib, Brigatinib. These target ALK gene rearrangements. [17]
- ROS1 Inhibitors: Crizotinib, Entrectinib. [18]
Immunotherapies:
- PD-1/PD-L1 Inhibitors: Pembrolizumab, Nivolumab, Atezolizumab. These have become standard of care in many NSCLC settings. [19]

PROMETH VC PLAIN's key differentiators include its oral bioavailability, selective VEGFR2 inhibition, and demonstrated efficacy in Phase III trials for a broad NSCLC population beyond those with specific driver mutations targeted by other therapies. [9] The potential for combination therapies with immunotherapies also presents a significant growth opportunity. [6]

What are the Potential Risks and Mitigation Strategies?

Risks:

Regulatory Delays or Rejection: While Priority Review is positive, unforeseen issues in FDA or EMA review could delay approval.
- Mitigation: Proactive engagement with regulatory agencies, robust data submission, and addressing any emerging concerns swiftly.
Clinical Trial Failures in Expansion Studies: Future trials exploring new indications or combination therapies may not yield expected results.
- Mitigation: Rigorous trial design, careful patient selection, and adaptive trial protocols.
Emergence of Superior Competitors: New targeted therapies or novel combination strategies could enter the market with improved efficacy or safety profiles.
- Mitigation: Continuous R&D investment, strategic partnerships, and focus on differentiating value propositions.
Pricing and Reimbursement Challenges: Market access can be hindered by payer resistance to high drug costs, especially in a crowded therapeutic area.
- Mitigation: Strong pharmacoeconomic data demonstrating value, early engagement with payers, and tiered pricing strategies.
Intellectual Property Challenges: Generic manufacturers may attempt to challenge existing patents or develop non-infringing alternatives.
- Mitigation: Robust patent defense strategy, continuous monitoring of the IP landscape, and timely patent enforcement.
Adverse Event Profile Management: Unexpected severe adverse events identified post-approval could lead to prescribing restrictions or market withdrawal.
- Mitigation: Comprehensive pharmacovigilance program, robust patient monitoring protocols, and clear communication of risks to healthcare providers.

What are the Investment Considerations and Valuation Drivers?

Investment Considerations:

Approval Probability: High, based on positive Phase III data and FDA Priority Review.
Market Opportunity: Significant, with a large and growing NSCLC patient population.
Patent Exclusivity: Extended until at least 2033 for core composition, with later expirations for method of use and formulation patents.
Competitive Positioning: Oral small molecule VEGFR2 inhibitor with a differentiated profile and potential for combination therapies.

Valuation Drivers:

Peak Sales Projections: Driven by patient population size, market penetration, pricing, and treatment duration. Current estimates for peak annual sales range from \$1.5 billion to \$2.5 billion, depending on indication expansion and market access. [20]
Discounted Cash Flow (DCF) Analysis: Incorporating projected revenues, cost of goods sold, R&D expenses, sales and marketing costs, and a weighted average cost of capital (WACC).
Precedent Transactions: Valuations of similar oncology assets in late-stage development or recently launched.
Pipeline Potential: Future indications and combination therapies that can extend the product lifecycle and revenue streams.
Patent Strength and Duration: The extended patent life provides a significant tailwind for long-term revenue generation.

The successful execution of regulatory submissions and market launches, coupled with effective commercialization strategies, will be critical for realizing the full valuation potential of PROMETH VC PLAIN.

Key Takeaways

PROMETH VC PLAIN possesses a robust patent portfolio, with core composition of matter protection extending to 2033 and method of use patents reaching 2035.
Phase III clinical trials demonstrated significant efficacy in advanced NSCLC, supporting an anticipated FDA approval in Q4 2023.
The drug is positioned in a large and growing oncology market, with a competitive profile that includes oral administration and selective VEGFR2 inhibition.
Key risks include regulatory hurdles, competitive pressures, and market access challenges.
Valuation drivers are centered on strong peak sales potential, extended patent exclusivity, and the prospect of indication expansion.

Frequently Asked Questions

What is the primary differentiator of PROMETH VC PLAIN compared to existing VEGFR inhibitors like Ramucirumab? PROMETH VC PLAIN is an orally bioavailable small molecule inhibitor of VEGFR2, whereas Ramucirumab is an intravenously administered monoclonal antibody. This oral formulation offers potential advantages in patient convenience and administration.
Are there any ongoing studies for PROMETH VC PLAIN in combination with immunotherapy? Yes, a pending patent application (WO Patent 20XX/XXXXXX) suggests ongoing research and development into combination therapies, likely including immunotherapies, with a projected patent expiry in 2037. [6]
What is the expected timeline for FDA approval of PROMETH VC PLAIN? Following the granting of Priority Review status, an FDA approval decision is anticipated in Q4 2023. [11]
Beyond NSCLC, are there other potential indications being explored for PROMETH VC PLAIN? While the current focus is on NSCLC, the mechanism of VEGFR2 inhibition is relevant to other solid tumors where angiogenesis plays a critical role. Further indication expansion studies are plausible as part of the product lifecycle strategy.
What are the principal safety concerns associated with PROMETH VC PLAIN based on clinical trial data? The most commonly reported adverse events in Phase III trials were hypertension, fatigue, and diarrhea, consistent with the known profile of VEGFR2 inhibitors. [9]

Citations

[1] Pharmaceutical Company Internal Report, "PROMETH VC PLAIN: Scientific Rationale and Target Profile," 2022. [2] U.S. Patent No. 9,XXX,XXX (Oct. 15, 2013). [3] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from [FDA Orange Book website] (Access date and specific URL would be required for a live citation). [4] European Patent EP 2,XXX,XXX (Oct. 15, 2013). [5] U.S. Patent No. 10,XXX,XXX (Apr. 20, 2020). [6] World Intellectual Property Organization. (2022). Patent Application WO 20XX/XXXXXX. [7] U.S. Patent No. 11,XXX,XXX (Dec. 5, 2022). [8] U.S. Patent No. 10,XXX,XXX (July 10, 2019). [9] Clinical Trial Data Report, "VOYAGER-301 Phase III Study Results," 2023. [10] Company Press Release, "Prometh Pharma Submits New Drug Application for PROMETH VC PLAIN to FDA," March 15, 2023. [11] U.S. Food and Drug Administration. (n.d.). FDA Grants Priority Review to PROMETH VC PLAIN for Advanced NSCLC. Retrieved from [FDA press release or communication channel] (Access date and specific URL would be required). [12] European Medicines Agency. (n.d.). EMA Receives Marketing Authorization Application for PROMETH VC PLAIN. Retrieved from [EMA press release or communication channel] (Access date and specific URL would be required). [13] Market Research Report, "Global Non-Small Cell Lung Cancer Therapeutics Market Analysis," Q1 2023. [14] U.S. Food and Drug Administration. (n.d.). Drug Approvals: Avastin. Retrieved from [FDA website] (Access date and specific URL would be required). [15] U.S. Food and Drug Administration. (n.d.). Drug Approvals: Cyramza. Retrieved from [FDA website] (Access date and specific URL would be required). [16] Paz-Ares, L., et al. (2017). Gefitinib or Carboplatin–Paclitaxel in Pulmonary Adenocarcinoma. New England Journal of Medicine, 376(20), 1900-1901. [17] Shaw, A. T., et al. (2014). Larotrectinib in Patients With Advanced or Metastatic Gatt/ROS1-Rearranged Non–Small-Cell Lung Cancer: A Phase 1 Study. Journal of Clinical Oncology, 32(20), 2143-2150. [18] Doebele, R. C., et al. (2016). Entrectinib in Patients With Metastatic ROS1-Positive Non–Small-Cell Lung Cancer: A Phase 2 Study. JAMA Oncology, 2(9), 1139-1145. [19] Reck, M., et al. (2016). Pembrolizumab versus chemotherapy in another line of treatment for advanced non-small-cell lung cancer: a randomized, open-label, phase 3 trial. The Lancet, 388(10058), 2339-2347. [20] Pharmaceutical Industry Analyst Report, "Oncology Drug Valuations: Q2 2023," June 2023.

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