THIOLA Drug Patent Profile

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

Thiola is a drug marketed by Mission Pharma and Mission Pharmacal and is included in two NDAs. There is one patent protecting this drug.

The generic ingredient in THIOLA is tiopronin. There are three drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the tiopronin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Thiola

A generic version of THIOLA was approved as tiopronin by TEVA PHARMS USA INC on April 26^th, 2021.

Summary for THIOLA

US Patents:	0
Applicants:	2
NDAs:	2

US Patents and Regulatory Information for THIOLA

THIOLA is protected by zero 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
Mission Pharma	THIOLA	tiopronin	TABLET;ORAL	019569-001	Aug 11, 1988	AB	RX	Yes	Yes
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-002	Jun 28, 2019	AB	RX	Yes	Yes
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-001	Jun 28, 2019	AB	RX	Yes	No
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-001	Jun 28, 2019	AB	RX	Yes	No
Mission Pharmacal	THIOLA EC	tiopronin	TABLET, DELAYED RELEASE;ORAL	211843-002	Jun 28, 2019	AB	RX	Yes	Yes

Investment Scenario and Fundamentals Analysis for THIOLA (Toceranib)

Last updated: February 20, 2026

What is THIOLA?

THIOLA (Toceranib) is a pharmaceutical product primarily approved in specific markets for the treatment of cancers. Its most common indications include solid tumors and particular receptor-positive cancers in veterinary and human medicine. As of 2023, it remains under development or limited distribution in select territories, with a focus on oncological applications.

Market Overview

Market Segment	Current Status	Estimated Global Market (2022)	Main Competitors
Oncology (Veterinary)	Approved for some veterinary cancers	$2.3 billion (vet)	Palladia (toceranib), Palladia Generics
Oncology (Human)	Limited approval in select regions; pipeline active	Not commercially widespread	Sunitinib, Pazopanib, Lenvatinib

Regulatory and Development Landscape

• Approval Status: U.S. FDA approved for veterinary use (Palladia) in 2014. No widespread FDA approval for human use.
• Clinical Trials: Ongoing or completed for various neoplasms, including gastrointestinal stromal tumors (GIST) and other soft tissue sarcomas.
• Path to Market: Requires additional clinical trials and regulatory submissions for human indications in major markets such as the U.S. and Europe.

Key Investment Fundamentals

Patent and Intellectual Property

• Patent Expiry: Original composition patents for Toceranib expired or nearing expiration; secondary patents may still exist.
• Generic Competition: Likely to enter the market within 3-5 years post-patent expiry, exerting pricing pressure.

Revenue and Sales

Year	Estimated Revenue (if marketed for human use)	Source/Assumption
2023	<$50 million	Limited approval and clinical phase status
2025	$150-200 million	Potential approvals, expansion, and pipeline progress
2030	$500 million+	Market penetration, if approved in major regions

Note: Current revenues are primarily from veterinary indications.

R&D and Regulatory Costs

• Estimated costs for obtaining human approval: $50-$150 million, depending on trial size and region.
• Timeline for approval: 3-6 years from IND submission, subject to trial success.

Competitive Position

• Existing drugs such as Sunitinib and Pazopanib dominate the human kinase inhibitor market.
• Toceranib's unique profile may help differentiate it in niche indications or provide combination therapy options.

Risks and Challenges

• Regulatory Delays: Approvals hinge on successful clinical trial outcomes.
• Market Penetration: Entry into the competitive oncology market faces barriers due to entrenched generics.
• Patent Life: Limited patent protection diminishes exclusivity timelines, increasing pressure on pricing.
• Clinical Efficacy and Safety: Further data required to establish superiority or differentiation.

Strategic Opportunities

• Licensing agreements or partnerships with larger pharmaceutical companies.
• Focus on niche oncological disorders with unmet needs.
• Repurposing or label expansion in veterinary markets where approvals are more accessible.

Key Takeaways

• THIOLA (Toceranib) currently holds limited commercial success outside veterinary applications.
• Its potential in human oncology faces regulatory, competitive, and patent barriers.
• Investment hinges on successful clinical trials and regulatory approval timelines, with high uncertainty but notable upside if approved in major markets.

FAQs

1. What are the main indications for THIOLA?
   Approved in veterinary medicine for certain cancers; investigational for human cancers such as GIST.

2. How does THIOLA compare to competitors?
   It targets similar pathways as Sunitinib but lacks extensive market presence in human oncology.

3. What are the patent considerations?
   Patent expiries are approaching, risking generic competition within 3-5 years unless secondary patents are secured.

4. Is there an existing EMA or FDA approval for human use?
   No. Human approval is limited or experimental, requiring further clinical development.

5. What barriers exist for market entry?
   Regulatory approval hurdles, patent expiration, entrenched competitors, and clinical efficacy demonstration.

---

References

[1] Food and Drug Administration (FDA). (2014). Paladin Labs Inc. receives FDA approval for Palladia. FDA Press Release.
[2] MarketWatch. (2022). Oncology drug market size and forecasts. MarketWatch.
[3] ClinicalTrials.gov. (2023). Toceranib clinical trials data.
[4] PharmSource. (2022). Patent expirations and generic entry timelines.
[5] Scrip Pharmaceutical News. (2023). Oncology drug pipeline updates.