Clopidogrel bisulfate - Generic Drug Details

What are the generic sources for clopidogrel bisulfate and what is the scope of freedom to operate?

Clopidogrel bisulfate is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Acme Labs, Actavis Totowa, Alkem Labs Ltd, Amneal Pharms, Ani Pharms, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, MSN, Polygen Pharms, Prinston Inc, Rising, Sciegen Pharms Inc, Sun Pharm, Sun Pharm Industries, Teva, Torrent Pharms Ltd, Zydus Lifesciences, and Sanofi Aventis Us, and is included in twenty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-five drug master file entries for clopidogrel bisulfate. Forty-four suppliers are listed for this compound.

Summary for clopidogrel bisulfate

US Patents:	0
Tradenames:	2
Applicants:	24
NDAs:	26
Drug Master File Entries:	45
Finished Product Suppliers / Packagers:	44
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	19
Patent Applications:	7,563
Drug Prices:	Drug price trends for clopidogrel bisulfate
Drug Sales Revenues:	Drug sales revenues for clopidogrel bisulfate
What excipients (inactive ingredients) are in clopidogrel bisulfate?	clopidogrel bisulfate excipients list
DailyMed Link:	clopidogrel bisulfate at DailyMed

See drug prices for clopidogrel bisulfate

See drug sales revenues for clopidogrel bisulfate

Recent Clinical Trials for clopidogrel bisulfate

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

Sponsor	Phase
Joint Stock Company "Farmak"	Phase 1
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	N/A
The First Affiliated Hospital with Nanjing Medical University	Phase 4

See all clopidogrel bisulfate clinical trials

Pharmacology for clopidogrel bisulfate

Drug Class	P2Y12 Platelet Inhibitor
Mechanism of Action	Cytochrome P450 2C8 Inhibitors P2Y12 Receptor Antagonists
Physiological Effect	Decreased Platelet Aggregation

Anatomical Therapeutic Chemical (ATC) Classes for clopidogrel bisulfate

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

Paragraph IV (Patent) Challenges for CLOPIDOGREL BISULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PLAVIX	Tablets	clopidogrel bisulfate	300 mg	020839	1	2009-03-04

US Patents and Regulatory Information for clopidogrel bisulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dr Reddys Labs Ltd	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	091023-002	Aug 5, 2024	AB	RX	No	No
Dr Reddys	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	076273-001	Jan 14, 2008	AB	RX	No	No
Actavis Totowa	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	090307-001	May 28, 2013		DISCN	No	No
Polygen Pharms	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	213351-001	Jul 17, 2020	AB	RX	No	No
Chartwell Rx	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	202266-002	Nov 20, 2012		DISCN	No	No

Expired US Patents for clopidogrel bisulfate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-001	Nov 17, 1997
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-001	Nov 17, 1997
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-002	Sep 20, 2007
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-002	Sep 20, 2007
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-001	Nov 17, 1997

Clopidogrel bisulfate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Clopidogrel Bisulfate

Introduction

Clopidogrel bisulfate, a widely used antiplatelet medication, is crucial in the prevention of thrombotic events such as heart attacks and strokes. Here, we delve into the market dynamics and financial trajectory of this drug, exploring its current state, future projections, and the factors influencing its market.

Market Size and Growth Projections

The global clopidogrel bisulfate market was valued at USD 50 billion in 2023 and is projected to reach USD 81.08 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 8.5% from 2024 to 2031[1].

Segmentation and Applications

The market is segmented based on application, product, and geographical regions. Key applications include the prevention of heart attacks and strokes, peripheral arterial disease, acute coronary syndrome, and stent thrombosis. The product segment includes tablets, capsules, and oral solutions. Geographically, the market is dominated by North America and Europe due to their advanced healthcare systems and high prevalence of cardiovascular diseases[1].

Drivers of Market Growth

Several factors drive the growth of the clopidogrel bisulfate market:

• Increasing Prevalence of Cardiovascular Diseases: The rising incidence of cardiovascular disorders such as peripheral artery disease and coronary artery disease fuels the demand for effective antiplatelet medications like clopidogrel bisulfate[1].
• Generic and Biosimilar Versions: Regulatory approvals for generic and biosimilar versions of clopidogrel bisulfate have made the medication more affordable and accessible, increasing market uptake[1].
• Technological Advancements: Improvements in drug formulations and delivery technologies enhance therapeutic outcomes, further driving market expansion[1].
• Healthcare Access Initiatives: Efforts by healthcare organizations to increase patient access to necessary pharmaceuticals also contribute to market growth[1].

Financial Performance and Trends

Historically, the financial performance of clopidogrel bisulfate has been significant, particularly when it was under patent. For instance, Sanofi-Aventis, the original manufacturer of Plavix (the brand name for clopidogrel bisulfate), saw a substantial impact on its sales when generic versions entered the market. However, after a preliminary injunction halted generic sales, U.S. sales of Plavix rebounded, reaching nearly the same levels as before the generic competition[2].

Impact of Generic Competition

Generic competition has been a significant factor in the financial trajectory of clopidogrel bisulfate. The entry of generic versions led to a decline in sales for the branded product, but regulatory actions and the depletion of generic stockpiles have allowed branded sales to recover temporarily. Despite this, the long-term trend indicates increased competition from generics, which is expected to continue[2].

Price Dynamics

Recently, there has been a steady drop in the prices of clopidogrel bisulfate globally. This decline is attributed to factors such as regional demand shifts, economic conditions, and increased supply due to new manufacturers entering the market. The higher cost of freight and changing downstream consumer practices have also contributed to this trend. This price reduction is expected to persist, benefiting healthcare systems and patients by reducing overall healthcare costs[3].

Regional Analysis

The market for clopidogrel bisulfate varies significantly across different regions. North America and Europe currently dominate the market due to their advanced healthcare systems and high rates of cardiovascular disease. However, other regions such as Asia-Pacific are also expected to grow as healthcare access and awareness increase[1].

Competitive Landscape

The competitive landscape of the clopidogrel bisulfate market is characterized by several key players, including Modasa Pharmaceuticals and Jubilant Pharma. These companies are focusing on expanding their product portfolios and business operations globally. The market is also subject to a Porter’s Five Forces analysis, which highlights the bargaining power of buyers and suppliers, the threat of new entrants, the threat of substitutes, and the degree of competition[1][4].

Technological and Regulatory Factors

Technological advancements in drug formulations and delivery technologies continue to enhance the therapeutic efficacy of clopidogrel bisulfate. Regulatory bodies play a crucial role in ensuring that all generic versions meet stringent safety and efficacy standards. This oversight is essential for maintaining the quality and efficacy of the medication despite the entry of new manufacturers and the resulting price competition[1][3].

Consumer and Healthcare Implications

The declining prices of clopidogrel bisulfate have broader implications for healthcare systems. Lower drug prices can lead to reduced overall healthcare costs, which is particularly beneficial for public health programs and insurance providers. However, it is essential to ensure that the quality and efficacy of the medication remain uncompromised despite the price reductions[3].

Future Outlook

The future outlook for the clopidogrel bisulfate market is positive, driven by increasing demand for antiplatelet medications, advancements in technology, and the expansion of healthcare access. However, the market will continue to face challenges from generic competition and regulatory dynamics. As competition increases and manufacturing technologies advance, patients and healthcare systems are expected to benefit from more affordable and effective treatment options[1][4].

Key Takeaways

• The global clopidogrel bisulfate market is projected to grow significantly, driven by increasing cardiovascular disease prevalence and technological advancements.
• Generic and biosimilar versions have made the medication more affordable and accessible.
• Price reductions due to increased supply and competition are expected to persist.
• Regulatory oversight is crucial for maintaining the quality and efficacy of the medication.
• The market is dominated by North America and Europe but is expected to grow in other regions as well.

Frequently Asked Questions (FAQs)

1. What is the current market size of clopidogrel bisulfate, and what are its growth projections?

The global clopidogrel bisulfate market was valued at USD 50 billion in 2023 and is expected to reach USD 81.08 billion by 2031, growing at a CAGR of 8.5% from 2024 to 2031[1].

2. What are the main drivers of the clopidogrel bisulfate market?

The main drivers include the increasing prevalence of cardiovascular diseases, the availability of generic and biosimilar versions, technological advancements in drug formulations, and efforts to increase patient access to necessary pharmaceuticals[1].

3. How has generic competition affected the market for clopidogrel bisulfate?

Generic competition has led to a decline in sales for the branded product but has also made the medication more affordable and accessible. Regulatory actions have sometimes temporarily halted generic sales, allowing branded sales to recover[2].

4. What are the regional trends in the clopidogrel bisulfate market?

North America and Europe currently dominate the market due to their advanced healthcare systems and high rates of cardiovascular disease. However, other regions such as Asia-Pacific are also expected to grow as healthcare access and awareness increase[1].

5. How do technological advancements impact the clopidogrel bisulfate market?

Technological advancements in drug formulations and delivery technologies enhance therapeutic outcomes, driving market expansion. These advancements also help in maintaining the quality and efficacy of the medication despite the entry of new manufacturers[1][3].

Sources:

1. Market Research Intellect, "Clopidogrel Bisulfate Market Size and Projections".
2. S&P Global, "Brighter Outlook Predicted as Sanofi-Aventis's Q1 Sales Start to Pick Up".
3. ChemAnalyst, "Steady Drop in Clopidogrel Bisulfate Prices in May, Likely to sustain its momentum".
4. Cognitive Market Research, "Clopidogrel Bisulfate Market Report 2024 (Global Edition)".
5. American Heart Association Journals, "Clinical Outcomes of Plavix and Generic Clopidogrel for Patients".