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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ticlid

A generic version of TICLID was approved as ticlopidine hydrochloride by APOTEX on July 1^st, 1999.

Summary for TICLID

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	1
Patent Applications:	1,935
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	019979-001	Mar 24, 1993	4,591,592
Roche Palo	TICLID	ticlopidine hydrochloride	TABLET;ORAL	019979-002	Oct 31, 1991	4,051,141

International Patents for TICLID

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

Country	Patent Number	Title	Estimated Expiration
Philippines	11759	NEW PYRIDINE DERIVATIVES AND PROCESS FOR THEIR PREPARATIO
Japan	S5753414	STABILIZED MEDICINAL COMPOSITION
Australia	507645
Greece	60364	PREPARATION PROCESS OF THIENOPYRIDINE DERIVATIVES
Norway	143225
Denmark	321081
New Zealand	181687	5-SUBSTITUTEDALKYL-4,5,6,7-TETRAHYDROTHIENO (3,2-C)PYRIDINES

TICLID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ticlid (Ticlopidine)

Overview of Ticlid

Ticlid, known generically as ticlopidine, is a platelet aggregation inhibitor used primarily to prevent conditions associated with thrombi, such as stroke and transient ischemic attacks (TIAs). It is marketed under the brand name Ticlid and is indicated for patients who cannot take aspirin or in whom aspirin has not been effective in preventing thrombotic stroke[2].

Market Size and Growth

The global pharmaceutical market, within which ticlopidine operates, was valued at approximately $1.475 trillion in 2022 and is expected to grow at a CAGR of 5% over the next six years. While specific figures for the ticlopidine market are not provided, it is part of the broader anti-thrombotic drugs market, which was valued at $23.5 billion in 2013 and expected to reach $25.9 billion by 2018[4].

Key Players

The ticlopidine hydrochloride API market involves several key players, including Clearsynth, Siegfried AG, Sato Yakuhin Kogyo, Sanofi, Teva, Biotechnica Pharma Global, RPG Life Sciences, DEAFARMA, HELM Portugal, Roche, Aarti Drugs, Apotex, Av Kare, and Eon Labs. These companies play a significant role in the production and distribution of ticlopidine[1].

Competitive Landscape

The anti-thrombotic drugs market, including anti-platelet agents like ticlopidine, is highly competitive. The market is dominated by other anti-platelet drugs such as clopidogrel (Plavix), which was the leader in this segment until its patent expired in 2012. The expiration of clopidogrel's patent led to a sharp decline in its sales, creating opportunities for other drugs like ticlopidine to fill the gap[4].

Pricing Dynamics

Generic drug prices, including those for ticlopidine, tend to decline as the number of competitors increases. According to the Federal Trade Commission, generic drug prices fall with the number of competitors but remain above long-run marginal costs until there are 8 or more competitors. This suggests that as more generic versions of ticlopidine enter the market, prices are likely to decrease[3].

Sales Performance

Historically, ticlopidine has been used as an alternative to aspirin for patients who cannot tolerate aspirin or in whom aspirin is ineffective. However, its use has been limited due to significant side effects, including neutropenia, aplastic anemia, thrombotic thrombocytopenia purpura, and agranulocytosis, which are highlighted in a black-box warning by the FDA[2].

Despite these limitations, ticlopidine remains a viable option in certain clinical scenarios. For instance, it is used as adjunctive therapy with aspirin to reduce the incidence of subacute stent thrombosis in patients undergoing successful coronary stent implantation[5].

Financial Trajectory

The financial trajectory of ticlopidine is influenced by several factors, including market competition, regulatory environment, and the emergence of new anti-thrombotic drugs.

• Market Saturation: The global anti-thrombotic drugs market is close to saturation, with fierce competition among existing drugs. This saturation can limit the growth potential of ticlopidine unless it can carve out a niche market or demonstrate superior efficacy and safety compared to other options[4].

• Generic Competition: As generic versions of ticlopidine become more prevalent, the prices are expected to decrease, which can impact the revenue generated by the drug. However, this also makes the drug more accessible to a wider patient population, potentially increasing volume sales[3].

• New Entrants: The emergence of new direct thrombin inhibitors and direct coagulation factor Xa inhibitors poses a challenge to ticlopidine. Drugs like dabigatran etexilate and rivaroxaban have gained significant market share, further intensifying competition in the anti-thrombotic market[4].

Regional Market Performance

The performance of ticlopidine varies across different regions. For example:

• Global Market: The global sales of anti-platelet drugs, including ticlopidine, were significant, with anti-platelet drugs accounting for 40.4% of all anti-thrombotic drug sales in 2013[4].

• Chinese Market: In the Chinese market, the sales of anti-thrombotic drugs, including anti-platelet agents, have shown growth. However, the market share of ticlopidine specifically is not as dominant as other anti-platelet drugs like clopidogrel[4].

Regulatory and Safety Considerations

Ticlopidine's use is heavily regulated due to its significant side effects. The FDA has included a black-box warning for neutropenia, aplastic anemia, thrombotic thrombocytopenia purpura, and agranulocytosis, necessitating regular monitoring of patients' white blood cell and platelet counts[2].

Future Outlook

The future outlook for ticlopidine is mixed:

• Challenges: The drug faces significant competition from newer and safer anti-thrombotic agents. The side effect profile of ticlopidine limits its widespread adoption, making it less favorable compared to other options[2][4].

• Opportunities: Despite these challenges, ticlopidine remains an option for patients who cannot take aspirin or other anti-platelet drugs. Its continued use in specific clinical scenarios ensures a niche market, although the overall market share is likely to remain limited.

Key Takeaways

• Market Competition: Ticlopidine operates in a highly competitive anti-thrombotic drugs market dominated by other anti-platelet agents.
• Pricing Dynamics: Prices of ticlopidine are expected to decrease as more generic versions enter the market.
• Regulatory Considerations: Significant side effects necessitate careful patient monitoring.
• Future Outlook: Ticlopidine will likely maintain a niche market but face challenges from newer, safer drugs.

FAQs

What is Ticlid used for?

Ticlid (ticlopidine) is used to prevent blood clots and stroke, particularly in patients who cannot take aspirin or in whom aspirin has not been effective.

Who are the key players in the ticlopidine market?

Key players include Clearsynth, Siegfried AG, Sato Yakuhin Kogyo, Sanofi, Teva, Biotechnica Pharma Global, and others.

Why is ticlopidine less commonly used compared to other anti-platelet drugs?

Ticlopidine is less commonly used due to its significant side effects, including neutropenia, aplastic anemia, thrombotic thrombocytopenia purpura, and agranulocytosis.

How does the emergence of new anti-thrombotic drugs affect ticlopidine?

The emergence of new direct thrombin inhibitors and direct coagulation factor Xa inhibitors poses a significant challenge to ticlopidine, potentially reducing its market share.

What is the expected pricing trend for ticlopidine?

As more generic versions of ticlopidine enter the market, prices are expected to decrease, making the drug more accessible but potentially reducing revenue.

Sources

1. Ticlopidine Hydrochloride API - Market, Report Size, Worth ... - Valuates Reports
2. Ticlopidine: Uses, Interactions, Mechanism of Action - DrugBank
3. Generic Drug Industry Dynamics - Federal Trade Commission
4. Recent progress and market analysis of anticoagulant drugs - Fan
5. Drug Class Review on Newer Antiplatelet Agents - OHSU