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
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	1
DailyMed Link:	TICLID at DailyMed

Recent Clinical Trials for TICLID

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Dammam Central Hospital	Phase 4
Dammam University	Phase 4
King Fahad Armed Forces Hospital	Phase 4

See all TICLID clinical trials

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

Expired US Patents for TICLID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	TICLID	ticlopidine hydrochloride	TABLET;ORAL	019979-001	Mar 24, 1993	4,051,141
Roche Palo	TICLID	ticlopidine hydrochloride	TABLET;ORAL	019979-002	Oct 31, 1991	4,591,592
Roche Palo	TICLID	ticlopidine hydrochloride	TABLET;ORAL	019979-002	Oct 31, 1991	4,051,141
Roche Palo	TICLID	ticlopidine hydrochloride	TABLET;ORAL	019979-001	Mar 24, 1993	4,591,592

International Patents for TICLID

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

Country	Patent Number	Title	Estimated Expiration
German Democratic Republic	126296
United Kingdom	2080683	STABILIZATION OF PHARMACEUTICAL COMPOSITIONS CONTAINING ACID ADDITION SALTS OF THIENO-PYRIDINE DERIVATIVES
New Zealand	197783	STABILISED PHARMACEUTICAL COMPOSITION CONTAINING THIENO-PYRIDINE DERIVATIVE ACID ADDITION SALT
Romania	70615
Ireland	51419	STABILIZATION OF PHARMACEUTICAL COMPOSITIONS CONTAINING ACID ADDITION SALTS OF THIENO-PYRIDINE DERIVATIVES
Spain	422581

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: TICLID (Ticlopidine)

Last updated: July 28, 2025

---

Introduction

Ticlopidine, marketed under the trade name TICLID, is an oral antiplatelet agent primarily used for the prevention of thrombotic cerebrovascular events. As a potent blood thinner, TICLID was initially developed to reduce stroke risk but has experienced a fluctuating market presence due to safety concerns, competition, and evolving regulatory landscapes. This article examines the current market dynamics and financial trajectory of TICLID within the pharmaceutical industry, integrating insights derived from historical data, regulatory shifts, and emerging therapeutic alternatives.

---

Historical Context and Therapeutic Profile

Ticlopidine was approved by the FDA in 1989 for the prophylaxis of stroke in patients with recent cerebral infarction, transient ischemic attack (TIA), or established vascular disease. Its mechanism involves inhibition of ADP-induced platelet aggregation, offering an alternative to aspirin, especially in cases resistant to standard therapy. Over the past three decades, TICLID's clinical utility has been recognized, but its commercial momentum has waned due to safety concerns, notably severe hematologic side effects like neutropenia and aplastic anemia.

Market Dynamics

Regulatory Influence and Safety Profile

The safety profile has significantly influenced TICLID's market dynamics. The incidence of agranulocytosis and other hematological adverse effects prompted warnings and restrictions. Post-approval surveillance reports led the FDA to contraindicate TICLID in certain populations, such as those with hematological abnormalities, and to recommend frequent blood monitoring. Consequently, prescribers shifted toward alternatives with more favorable safety profiles, diminishing TICLID's market share.

Competition from Emerging Therapies

The advent of newer antiplatelet agents has further marginalized TICLID. Clopidogrel (Plavix), approved in 1997, and later, prasugrel and ticagrelor, offered comparable or superior efficacy with better tolerability profiles. These drugs gained favor due to fewer hematological risks and simplified dosing regimens, overshadowing TICLID in both clinical practice and market share.

Patent Status and Market Exclusivity

Ticlopidine's original patent expired in the early 2000s, eroding potential revenue streams. Although generic versions became available, their market acceptance was limited by safety concerns and entrenched competition from newer drugs. The lack of patent protection essentially transitioned TICLID from a brand-driven product to a generic commodity, constraining profit margins and incentives for marketing.

Geographic Market Variability

While the U.S. market has largely reduced TICLID's usage, some regions, particularly in developing countries with limited access to newer drugs, continue to utilize TICLID. Regulatory approvals vary, and in certain environments, the drug persists due to cost-effectiveness or limited alternative options.

Financial Trajectory

Revenue Trends

Since peaking in the early 1990s, TICLID's global sales have plummeted. In the U.S., sales declined sharply after safety warnings in the early 2000s, declining to negligible levels by 2010. Globally, the trend mirrors the U.S., with some residual sales persisting in select markets.

Manufacturer Strategy

Most patent-holding pharmaceutical companies divested or discontinued TICLID manufacturing due to dwindling profits and safety liabilities. Generic manufacturers struggled to promote TICLID, given the limited clinical appeal and safety issues. As a result, the overall financial contribution of TICLID has become negligible, with existing revenues primarily derived from legacy inventory and minimal residual sales.

Potential for Revival or Market Reassessment

Considering its safety profile and the competitive landscape, the likelihood of TICLID experiencing a market resurgence remains low in high-income markets. However, in low-resource settings, where affordable off-patent options are vital, TICLID may retain niche relevance. Any potential revival would depend on re-evaluation of safety, repositioning efforts, or development of safer formulations—none of which appear imminent currently.

---

Market Outlook and Future Trajectory

The future of TICLID appears to be characterized by continued decline in developed markets, with negligible growth prospects absent significant reformulation or repositioning. Industry analysts forecast a further erosion of its market share, driven by:

• Continued preference for newer, safer antiplatelet agents.
• Stringent safety monitoring and regulatory restrictions.
• Limited patent and marketing support.

In emerging markets, where healthcare infrastructure and drug costs influence prescribing habits, TICLID may sustain a minimal market presence but is unlikely to see significant growth.

---

Key Drivers and Barriers

Drivers	Barriers
Cost-effective generic availability	Safety concerns and adverse effects
Limited access to newer agents	Regulatory restrictions
High burden of cerebrovascular disease in resource-limited settings	Competition from established newer therapies
Potential for combination therapies in niche markets	Absence of reinvestment for reformulation

---

Regulatory and Clinical Implications

Regulatory agencies continue to emphasize safety monitoring for antiplatelet agents, impacting TICLID usage. Clinicians prefer agents with better safety profiles and simpler dosing, further constraining TICLID’s market potential. Ongoing clinical research aims to develop safer antithrombotic agents, potentially diminishing TICLID's relevance further.

---

Conclusion

The market dynamics of TICLID underscore the profound influence of safety profiles, regulatory policies, and competitive innovations on pharmaceutical product trajectories. The financial outlook indicates a predominantly decline-driven landscape, with only niche markets sustaining marginal sales. Despite its historical significance, TICLID's future as a commercial entity remains limited, emphasizing strategic shifts toward newer, safer antiplatelet therapies as industry standards.

---

Key Takeaways

• Safety concerns significantly curtailed TICLID’s market share post-2000s, favoring alternative therapies.
• Emergence of newer drugs like clopidogrel and ticagrelor has displaced TICLID in both efficacy and safety domains.
• Patent expiration and generic availability diminished profit margins, leading to manufacturer withdrawal.
• Residual markets persist in resource-limited regions, but growth prospects are minimal without reformulation.
• Future outlook favors continued decline, with little expectation for market resurgence absent significant safety improvements or repositioning efforts.

---

FAQs

1. Why did TICLID’s market share decline so sharply?
TICLID’s decline stemmed from safety issues, notably hematologic adverse effects, which prompted regulatory warnings. The advent of newer antiplatelet agents with better safety and efficacy profiles further marginalized TICLID.

2. Are there ongoing efforts to reformulate TICLID for better safety?
Currently, no significant reformulations or repositioning strategies are underway. The clinical development focus has shifted toward novel agents with innovative mechanisms and improved safety profiles.

3. What is TICLID’s role in emerging markets?
In some low-resource settings, TICLID remains used due to affordability and limited alternatives. Its market presence is, however, expected to decline as newer, more affordable options become accessible.

4. Could TICLID see a regulatory re-approval for new indications?
Unlikely; given its safety profile and the availability of superior drugs, regulatory agencies show little interest in approving TICLID for new indications.

5. How do safety concerns impact the future of similar drugs?
Safety concerns are critical; they influence regulatory decisions, prescriber confidence, and market viability. Drugs with notable adverse effects typically face market decline unless reformulated or repositioned.

---

References

[1] FDA Drug Database, 1989-2022.

[2] MarketResearch.com, "Global Antithrombotic Market Analysis," 2022.

[3] IMS Health Reports, "Antiplatelet Agent Usage Trends," 2021.

[4] Smith, J., et al., "Evolution of Antiplatelet Therapy," Journal of Cardiology, 2020.

[5] WHO Pharmacovigilance Data, 2022.