TIROFIBAN HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for tirofiban hydrochloride and what is the scope of patent protection?

Tirofiban hydrochloride is the generic ingredient in two branded drugs marketed by Medicure, Eugia Pharma, Gland Pharma Ltd, and Nexus, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for tirofiban hydrochloride. Five suppliers are listed for this compound.

Summary for TIROFIBAN HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	5
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	128
Clinical Trials:	54
Patent Applications:	2,194
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TIROFIBAN HYDROCHLORIDE
What excipients (inactive ingredients) are in TIROFIBAN HYDROCHLORIDE?	TIROFIBAN HYDROCHLORIDE excipients list
DailyMed Link:	TIROFIBAN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TIROFIBAN HYDROCHLORIDE

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

Sponsor	Phase
The First Affiliated Hospital of University of Science and Technology of China	Phase 3
Peking Union Medical College Hospital	Phase 3
Pharmaron (Chengdu) Clinical Services Co., Ltd.	Phase 3

See all TIROFIBAN HYDROCHLORIDE clinical trials

Pharmacology for TIROFIBAN HYDROCHLORIDE

Drug Class	Platelet Aggregation Inhibitor
Physiological Effect	Decreased Platelet Aggregation

Anatomical Therapeutic Chemical (ATC) Classes for TIROFIBAN HYDROCHLORIDE

B01AC	Platelet aggregation inhibitors excl. heparin
B01A	ANTITHROMBOTIC AGENTS
B01	ANTITHROMBOTIC AGENTS
B	Blood and blood forming organs

Paragraph IV (Patent) Challenges for TIROFIBAN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
AGGRASTAT	Injection	tirofiban hydrochloride	5 mg/100 mL	020913	1	2019-08-29
AGGRASTAT	Injection	tirofiban hydrochloride	12.5 mg/250 mL	020913	1	2018-10-03

US Patents and Regulatory Information for TIROFIBAN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nexus	TIROFIBAN HYDROCHLORIDE	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	213947-001	Feb 7, 2023	AP	RX	No	No
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-001	May 14, 1998		DISCN	No	No
Eugia Pharma	TIROFIBAN HYDROCHLORIDE	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	216379-002	May 1, 2023	AP	RX	No	No
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-002	May 17, 2002	AP	RX	Yes	No
Gland Pharma Ltd	TIROFIBAN HYDROCHLORIDE	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	206888-001	Apr 8, 2021	AP	RX	No	No
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-003	Apr 20, 2000	AP	RX	Yes	Yes
Nexus	TIROFIBAN HYDROCHLORIDE	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	213947-002	Jul 24, 2023	AP	RX	No	No

Expired US Patents for TIROFIBAN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-001	May 14, 1998
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-003	Apr 20, 2000
Medicure	AGGRASTAT	tirofiban hydrochloride	INJECTABLE;INJECTION	020912-001	May 14, 1998
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-001	May 14, 1998
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-002	May 17, 2002
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-003	Apr 20, 2000
Medicure	AGGRASTAT	tirofiban hydrochloride	SOLUTION;INTRAVENOUS	020913-002	May 17, 2002

TIROFIBAN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Tirofiban Hydrochloride

Introduction

Tirofiban hydrochloride, a non-peptide tyrosine derivative, is a potent inhibitor of the glycoprotein IIb/IIIa receptor, playing a crucial role in the management of acute coronary syndromes. This article delves into the market dynamics and financial trajectory of tirofiban hydrochloride, highlighting its current market status, growth projections, and economic impact.

Market Size and Growth Projections

The global tirofiban hydrochloride API market is anticipated to experience significant growth. As of 2024, the market size is estimated to be USD 328.5 million, with projections indicating it will reach USD 455.6 million by 2031. This growth is driven by a Compound Annual Growth Rate (CAGR) of 5.60% over the forecast period[1].

Key Market Segments

The tirofiban hydrochloride market is segmented based on type and application. The types include purity levels of ≥99% and <99%, while the applications are primarily categorized into injection and other uses. Understanding these segments is crucial for manufacturers and investors to target specific market needs and opportunities[1].

Driving Factors

Several factors are driving the growth of the tirofiban hydrochloride market. These include the increasing incidence of cardiovascular diseases, the need for effective antithrombotic therapies, and stringent regulatory requirements for drug safety and efficacy. Additionally, advancements in medical technology and the expanding geriatric population, which is more prone to cardiovascular conditions, contribute to the market's growth[1].

Economic Impact

The use of tirofiban hydrochloride in managing acute coronary ischemic syndromes has been shown to be economically beneficial. A study conducted in Switzerland revealed that the additional use of tirofiban, along with heparin and aspirin, resulted in net savings of CHF 54,899 (approximately ECU 33,418) per 100 patients. These savings were achieved through a reduction in the costs associated with treating refractory ischemic conditions and myocardial infarctions[3].

Clinical Efficacy and Cost Savings

Clinical trials, such as the RESTORE study, have demonstrated the efficacy of tirofiban in reducing cardiac ischemic events. The study showed a significant risk reduction in the composite endpoint of refractory ischemia, new myocardial infarction, and death at 7 days and 30 days post-treatment. This clinical efficacy translates into cost savings by reducing the need for prolonged hospital stays, intensive care, and revascularization procedures[2].

Stability and Compatibility

The stability and compatibility of tirofiban hydrochloride are critical for its clinical use. Studies have shown that tirofiban hydrochloride injection remains stable for at least four hours when combined with various other drugs, except for diazepam, which results in immediate precipitation. This stability ensures that tirofiban can be safely administered in combination with other necessary medications without compromising its efficacy[5].

Market Dynamics

The market for tirofiban hydrochloride is influenced by several dynamics, including the competitive landscape, regulatory environment, and technological advancements. The market is characterized by a few key players, and competition is driven by the quality and purity of the API, as well as the ability to meet stringent regulatory standards. Technological advancements in manufacturing processes and the development of new formulations are also shaping the market[4].

Regional Market Analysis

The global tirofiban hydrochloride market is diverse, with different regions exhibiting varying growth rates and market demands. Factors such as healthcare infrastructure, regulatory frameworks, and economic conditions in each region influence the market's growth. For instance, regions with well-developed healthcare systems and high prevalence of cardiovascular diseases are expected to drive the market's growth[4].

Challenges and Opportunities

Despite the positive growth projections, the tirofiban hydrochloride market faces several challenges. These include the high cost of production, stringent regulatory requirements, and the presence of generic competitors. However, opportunities exist in the form of expanding into emerging markets, developing new formulations, and leveraging advancements in medical technology to improve patient outcomes[1].

Financial Trajectory

The financial trajectory of tirofiban hydrochloride is promising, with steady growth anticipated over the next several years. The market's expansion is supported by increasing demand for effective antithrombotic therapies and the economic benefits associated with reduced healthcare costs. Investors and manufacturers are likely to see returns on their investments as the market continues to grow and mature[1].

Key Takeaways

• The global tirofiban hydrochloride API market is projected to grow from USD 328.5 million in 2024 to USD 455.6 million by 2031.
• The market is driven by increasing cases of cardiovascular diseases and stringent regulatory requirements.
• Tirofiban hydrochloride has been shown to be economically beneficial by reducing healthcare costs associated with treating acute coronary ischemic syndromes.
• Clinical efficacy and stability of the drug are crucial for its market success.
• Regional market dynamics and technological advancements play significant roles in shaping the market.

FAQs

What is the projected market size of tirofiban hydrochloride by 2031?

The tirofiban hydrochloride API market is anticipated to touch USD 455.6 million by 2031[1].

What is the CAGR of the tirofiban hydrochloride market?

The tirofiban hydrochloride market is anticipated to exhibit a CAGR of 5.60% by 2031[1].

What are the key segments of the tirofiban hydrochloride market?

The key market segments include purity levels (≥99% and <99%) and applications (injection and others)[1].

How does tirofiban hydrochloride impact healthcare costs?

The use of tirofiban hydrochloride has been shown to result in net savings by reducing the costs associated with treating refractory ischemic conditions and myocardial infarctions[3].

Is tirofiban hydrochloride stable when combined with other drugs?

Tirofiban hydrochloride is stable when combined with most other drugs, except for diazepam, which results in immediate precipitation[5].

Sources

1. Proficient Market Insights, Tirofiban Hydrochloride API Market Size, Share, Growth.
2. FDA, Aggrastat (tirofiban HCl Injection premixed).
3. PubMed, Economic assessment of tirofiban in the management of acute coronary ischaemic syndromes.
4. Market Research Reports, Global Tirofiban Hydrochloride Monohydrate Market 2024 by Manufacturers, Regions, Type and Application, Forecast to 2030.
5. PubMed, Stability and compatibility of tirofiban hydrochloride during simulated Y-site administration with various other drugs.