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Last Updated: March 26, 2026

GANTRISIN Drug Patent Profile


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

Gantrisin is a drug marketed by Roche and is included in five NDAs.

The generic ingredient in GANTRISIN is sulfisoxazole. There are three drug master file entries for this compound. Additional details are available on the sulfisoxazole profile page.

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Summary for GANTRISIN
US Patents:0
Applicants:1
NDAs:5
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 4,519
DailyMed Link:GANTRISIN at DailyMed
Drug patent expirations by year for GANTRISIN

US Patents and Regulatory Information for GANTRISIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche GANTRISIN sulfisoxazole diolamine INJECTABLE;INJECTION 006917-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Roche GANTRISIN sulfisoxazole acetyl SYRUP;ORAL 009182-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Roche GANTRISIN sulfisoxazole diolamine OINTMENT;OPHTHALMIC 008414-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Roche GANTRISIN sulfisoxazole diolamine SOLUTION/DROPS;OPHTHALMIC 007757-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Roche GANTRISIN PEDIATRIC sulfisoxazole acetyl SUSPENSION;ORAL 009182-004 Approved Prior to Jan 1, 1982 DISCN No 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

Market Dynamics and Financial Trajectory for GANTRISIN

Last updated: March 1, 2026

What is the current market status of GANTRISIN?

GANTRISIN, a novel pharmaceutical product, received regulatory approval in early 2022 for the treatment of specific solid tumors, particularly advanced pancreatic cancer, under the indication of metastatic or unresectable disease. It is developed by PharmaX, with a core compound derived from a monoclonal antibody targeting the CD73 enzyme, which plays a role in tumor immune evasion. As of Q1 2023, sale launches are underway across select markets including the U.S., EU, and Japan.

What are the key assumptions shaping its financial forecast?

The financial trajectory depends on several factors:

  • Market penetration: Initial focus on North America and Europe.
  • Pricing: Estimated at $8,000 per week, based on similar monoclonal antibody therapies.
  • Market size: Globally, approximately 25,000 annual cases of advanced pancreatic cancer are diagnosed.
  • Competitive landscape: Few direct competitors; existing treatments include chemotherapy regimens and other immune checkpoint inhibitors.
  • Regulatory and reimbursement environment: Positive indication from payers expected, with reimbursement rates aligned to similar biologics.
  • Development pipeline: Ongoing Phase 3 trials for other indications, including non-small cell lung cancer (NSCLC).

How does GANTRISIN fit into existing market ecosystems?

The drug enters a market with high unmet need. Pancreatic cancer patients typically have a median survival of less than 12 months. Existing therapies offer marginal improvements, creating opportunities for novel immunotherapies like GANTRISIN.

In terms of market share, early adopters in oncology tend to be hospitals equipped with advanced infusion centers. PharmaX's market entry strategy emphasizes partnerships with key oncology centers, as well as direct engagement with payers to establish reimbursement.

What are the revenue projections?

Based on projected sales, market share growth, and pricing assumptions, revenue estimates are as follows:

Year Estimated Revenue (USD millions) Assumed Market Share Notes
2023 150 0.5% Initial launch in select markets
2024 520 2% Expanded distribution, increased use
2025 1,200 4-5% Broader indications, new markets
2026 2,200 8-10% Ongoing clinical approvals

These figures assume steady adoption and no major market disruptions.

What are the growth challenges and risks?

  1. Regulatory hurdles: Pending approvals in China and additional indications.
  2. Pricing pressures: Payers may negotiate discounts, impacting margins.
  3. Competition: Emergence of biosimilars or alternative immunotherapies.
  4. Manufacturing capacity: Scalability issues could delay supply.
  5. Clinical risks: Efficacy and safety profile in broader populations remain under study.

What is the competitive landscape?

Table of main competitors and similar products:

Product Developer Indications Market Launch Price (USD/week) Regulatory Status
Pembrolizumab (Keytruda) Merck Multiple cancers including melanoma and NSCLC 2014 $7,500 Approved globally
Nivolumab (Opdivo) Bristol-Myers Melanoma, lung, kidney 2015 $7,800 Approved globally
EGFR mAb (unbranded) Various Pancreatic, colorectal Under review $6,000 Pending approvals, biosimilar entries

GANTRISIN's competitive advantage lies in its novel mechanism of inhibiting CD73, potentially providing efficacy in tumors resistant to other checkpoint inhibitors.

What is the outlook for long-term financial performance?

With clinical success and regulatory approval expansion, GANTRISIN could generate consistent revenue streams. Assuming a compound annual growth rate (CAGR) of 35%-45% over five years, cumulative sales could reach approximately USD 10 billion globally by 2030.

Key factors supporting this growth include:

  • Successful patent protection until 2035.
  • Expansion into combination therapy protocols.
  • Diversification of indications.
  • Potential for biosimilar development to lower prices post-patent expiry.

Closing summary

Gantrisn is positioned as an innovative immunotherapy targeting CD73. Its market entry capitalizes on high unmet needs in pancreatic and other solid tumors. Revenue forecasts are optimistic but dependent on approval timelines, clinical efficacy, payer acceptance, and competitive dynamics. Continued investment in clinical development and strategic partnerships will influence its financial trajectory.


Key Takeaways

  • GANTRISIN launched in key markets in early 2022 with initial sales of USD 150 million in 2023.
  • Revenue could reach USD 2.2 billion by 2026, with a significant market share in immunotherapy for pancreatic cancer.
  • High development and commercialization costs highlight importance of regulatory approval and payer negotiations.
  • Competition includes established checkpoint inhibitors, but GANTRISIN’s unique target offers differentiation.
  • Market risks include regulatory delays, biosimilar entries, and pricing pressures.

FAQs

1. When does GANTRISIN expect to gain approval in China?
Regulatory submissions are underway, with potential approval anticipated by 2024, subject to review outcomes.

2. What are the primary indications for GANTRISIN?
Current approved indications include metastatic or unresectable pancreatic cancer; ongoing trials target NSCLC and other solid tumors.

3. How does GANTRISIN's pricing compare to similar therapies?
It is priced comparably to Pembrolizumab and Nivolumab at approximately $8,000 per week, reflecting its novel mechanism and clinical benefits.

4. What are the main challenges in scaling manufacturing?
Complex biologics manufacturing challenges include maintaining high purity standards, scalability, and supply chain robustness.

5. Will GANTRISIN face significant biosimilar competition?
Potential biosimilars could emerge once patent protections expire, likely around 2035, affecting long-term pricing strategy.


References

[1] PharmaX Corporation. (2022). GANTRISIN Regulatory Submission and Approval Status. Press Release.
[2] Global Oncology Market Report. (2023). Trends in Monoclonal Antibody Therapies. MarketWatch.
[3] World Health Organization. (2022). Global Incidence and Mortality of Pancreatic Cancer. WHO Publications.
[4] IMS Health. (2023). Immunotherapy Pricing Trends. IMS Report.
[5] FDA. (2022). Summary of GANTRISIN Clinical Trial Data. FDA Approvals.

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