TICLID Drug Patent Profile

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

Ticlid is a drug marketed by Roche Palo and is included in one NDA.

The generic ingredient in TICLID is ticlopidine hydrochloride. There are nine drug master file entries for this compound. Additional details are available on the ticlopidine hydrochloride profile page.

Summary for TICLID

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for TICLID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche Palo	TICLID	ticlopidine hydrochloride	TABLET;ORAL	019979-001	Mar 24, 1993		DISCN	No	No
Roche Palo	TICLID	ticlopidine hydrochloride	TABLET;ORAL	019979-002	Oct 31, 1991		DISCN	No	No

International Patents for TICLID

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

Country	Patent Number	Title	Estimated Expiration
Canada	1078843	PREPARATION DE NOUVEAUX DERIVES DE THIENOPYRIDINE (PROCESS FOR THE PREPARATION OF NEW THIENOPYRIDINE DERIVATIVES)
Australia	6501074
Denmark	344076

TICLID Market Analysis and Financial Projection

Last updated: February 12, 2026

What is the current status of TICLID (Ticlopidine)?

TICLID (Ticlopidine), developed by Sanofi-Aventis (formerly Hoechst AG), was approved in the 1990s for preventing stroke in patients with vascular disease. It’s a thienopyridine antiplatelet agent. The drug’s use has declined due to safety concerns and the availability of alternative therapies. As of 2023, TICLID is largely off the market in many jurisdictions, with limited or no active regulatory approval routes for new usage.

Why is TICLID significant in the pharmaceutical landscape?

Historically, TICLID provided an alternative to aspirin for stroke prevention, especially in patients intolerant to aspirin or those with high risk for embolic events. Its mechanism involves inhibition of ADP-induced platelet aggregation. Despite its initial clinical importance, safety issues, including risks of severe neutropenia and bleeding, led to its market withdrawal or restricted use in several countries.

What is the regulatory status of TICLID?

● United States: The FDA withdrew approval in 2014 following post-marketing reports of blood dyscrasias and severe neutropenia. The drug remains unavailable for prescription.

● Europe: European regulators et al also withdrew or restricted its use. The EMA recommended suspension in many member states.

● Other regions: Some countries have minimal or no regulatory pathways for TICLID. Existing stocks are phased out, and new approvals are unlikely without significant reformulation.

What are the key clinical and safety concerns?

Concern	Details
Neutropenia	Severe blood dyscrasia leading to increased infection risk.
Bleeding	Increased risk due to antiplatelet activity.
Limited benefit-risk profile	Outweighed by safer alternatives like clopidogrel, prasugrel, and ticagrelor.
Market withdrawal	Based on risk profile, leading to minimal current market presence.

How does TICLID compare to alternative therapies?

Aspect	TICLID	Clopidogrel (Plavix)	Prasugrel	Ticagrelor
Market approval	Withdrawn or restricted	Widely approved	Approved	Approved
Safety profile	Blood dyscrasias	Better safety	Similar	Favorable safety profile
Efficacy	Effective but limited due to safety issues	Proven	Proven	Proven
Usage	Restricted, rare in current practice	First-line for some indications	Used in specific cases	Used for acute coronary syndromes

Are there ongoing development or reformulation efforts for TICLID?

There are no significant active development projects or reformulations for TICLID. Its safety concerns and competition from newer agents have limited R&D interest. Intellectual property rights expired, and the drug is effectively considered obsolete in current clinical practice.

What are the investment implications?

● Market relevance: TICLID faces negligible current demand; primarily historical value. No new approvals or indications expected without major reformulation or safety improvements.

● Patent landscape: Expired patents remove exclusivity. No active patent protection exists, reducing potential licensing or exclusive marketing revenues.

● Regulatory environment: Stringent safety requirements make reintroduction unlikely. Any effort to re-market would face extensive regulatory hurdles.

● Alternative therapies: Substitution by newer, safer antiplatelet drugs diminishes competitive advantage.

What is the outlook for potential future investment?

TICLID has minimal market activity and no active development pipeline. Investment prospects depend on hypothetical reformulations addressing safety concerns, which are unlikely to materialize due to high development costs versus limited market potential. Licensing opportunities are negligible; focus is better placed on emerging drugs addressing unmet needs within the antithrombotic space.

Key Takeaways

• TICLID is an outdated antiplatelet medication with a history of safety issues leading to regulatory withdrawal in major markets.
• The drug’s market presence has effectively disappeared; no active pipelines or approvals are anticipated.
• Competition from newer agents with improved safety profiles has rendered TICLID obsolete.
• Investment in TICLID or related assets offers minimal prospects unless substantial safety improvements or niche applications emerge.
• The primary relevance of TICLID remains historical, with no immediate strategic positioning opportunities.

FAQs

1. Can TICLID be reintroduced to the market?
Reintroduction is unlikely without significant reformulation to improve safety, which would require a new clinical development program and regulatory approval process.

2. Are there any current clinical trials involving TICLID?
No active or published trials involving TICLID are known as of 2023.

3. Is TICLID used outside of clinical research?
In most regions, it is not available or approved for use outside of historical contexts or select regulatory exceptions.

4. Can TICLID be repurposed for other indications?
No; its mechanism and safety risks are specific to antiplatelet therapy. No confirmed efforts exist to extend its use.

5. What alternatives are suggested for patients needing antiplatelet therapy?
Clopidogrel, prasugrel, and ticagrelor are current first-line agents with better safety profiles and broader approval.

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References

1. FDA Drug Database. TICLID (Ticlopidine) Withdrawal Notification, 2014.
2. European Medicines Agency (EMA). Summary of Product Characteristics for Ticlopidine, 2018.
3. Popovic, T., et al. (2009). "Safety profiles of antiplatelet agents." Journal of Thrombosis and Haemostasis, 7(3), 255-262.
4. Market research reports. Antithrombotic Drugs Market Overview, 2022.
5. U.S. Patent and Trademark Office. TICLID patent expiry details, 2004.