Clopidogrel bisulfate - Generic Drug Details

What are the generic drug sources for clopidogrel bisulfate and what is the scope of patent protection?

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, Prinston Inc, Puracap Labs Blu, Rising, Sciegen Pharms, 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. Thirty-six 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:	36
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	19
Drug Prices:	Drug price trends for clopidogrel bisulfate
Drug Sales Revenues:	Drug sales revenues for clopidogrel bisulfate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-001	Nov 17, 1997	AB	RX	Yes	No
Sciegen Pharms	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	204165-002	Sep 15, 2014	AB	RX	No	No
Rising	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	204359-001	Feb 2, 2017	AB	RX	No	No
Ani Pharms	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	091216-001	May 17, 2012		DISCN	No	No
Chartwell Rx	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	202266-002	Nov 20, 2012		DISCN	No	No
Sciegen Pharms	CLOPIDOGREL BISULFATE	clopidogrel bisulfate	TABLET;ORAL	204165-001	Sep 15, 2014	AB	RX	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	4,529,596

Market Dynamics and Financial Trajectory for Clopidogrel Bisulfate

Last updated: April 20, 2026

What is the Current Market Size and Growth Rate?

The global clopidogrel bisulfate market was valued at approximately USD 5 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 3.8% from 2023 to 2030. The increase aligns with broader trends in cardiovascular disease management.

Regional Distribution:

• North America: 45% of sales
• Europe: 30%
• Asia-Pacific: 15%
• Rest of the world: 10%

Market Drivers:

• Rising incidence of ischemic heart disease and stroke
• Increasing elderly population
• Growing adoption of antiplatelet therapy

Market Constraints:

• Patent expiries for key formulations
• Generic competition reducing prices
• Concerns over bleeding risks

Patent Status and Implications

The original patent for clopidogrel expired in the United States in 2012, opening the market to generics. Since then, multiple manufacturers have launched equivalent formulations. Brand-name versions like Plavix (manufactured by Bristol-Myers Squibb/Sanofi) faced generic competition, leading to significant price erosion.

Patent Timeline:

• Original patent expiry in the US: 2012
• Patent protections in other countries vary, some extending into the early 2020s
• New formulations and combinations continue to be patented, providing limited periods of exclusivity

Competitive Landscape

The market comprises several key players:

• Bristol-Myers Squibb/Sanofi (Plavix)
• Teva Pharmaceuticals
• Mylan
• Sun Pharma

Generics account for approximately 70% of global sales, compressing margins for branded products.

Pricing and Reimbursement Trends

Pricing for generic clopidogrel formulations has declined by approximately 50% since patent expiry. Reimbursement policies favor generic substitution, which constrains branded drug revenue.

Reimbursement Policies:

• In the US, Medicare includes clopidogrel in its formulary with preferred generic status.
• In Europe, national health systems rapidly adopt cost-saving generics.

R&D and Regulatory Opportunities

Research into new indications, combination therapies, and biosimilars influences market trajectory. Regulatory agencies have approved several new formulations with extended-release profiles or combination pills, which can command premium pricing.

Financial Outlook

Revenue projections indicate:

• Sale decline for branded formulations post-2012 patent expiry
• Growth potential for higher-cost, branded, or new formulations
• Increasing reliance on biosimilars and combination drugs

Forecast:	Year	Estimated Revenue (USD billion)
2022	5.0
2025	4.8
2030	6.5

The market is expected to recover and grow due to pipeline drugs targeting resistant cases, improved formulations, and combination therapies.

Key Market Dynamics Summary

• Patent expirations have led to a shift toward generics
• Price erosion constrains branded product revenues
• Demographic trends bolster demand for antiplatelet therapy
• Regulatory pathways for new formulations present growth opportunities

Key Takeaways

• The global market for clopidogrel bisulfate was USD 5 billion in 2022 and is projected to reach USD 6.5 billion by 2030.
• Patent expiries have resulted in significant generic competition, reducing pipeline revenues.
• Reimbursement policies favor generics, constraining branded sales.
• Innovation in formulations and combination therapies sustains product differentiation and potential premium pricing.
• Future growth hinges on pipeline development and regulatory approvals for new indications.

FAQs

1. How does patent expiration affect the clopidogrel market?
Patent expiry allows generic manufacturers to enter the market, increasing competition and reducing prices for branded formulations.

2. What are the main revenue drivers for clopidogrel?
Increasing cardiovascular disease prevalence and aging populations drive demand for antiplatelet drugs, although revenue is decreasing for brands due to generics.

3. Are there new formulations of clopidogrel under development?
Yes, regulatory agencies have approved extended-release and combination formulations aimed at improving compliance and therapeutic outcomes.

4. How do reimbursement policies influence market dynamics?
Reimbursement favors lower-cost generics, which suppresses revenues for branded drugs and incentivizes cost-effective prescribing.

5. What is the outlook for biosimilars in this market?
While biosimilars are more relevant for biologics, improvements in formulation and patent strategies may introduce similar cost-saving products for small-molecule drugs like clopidogrel.

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References

1. MarketWatch. (2023). Clopidogrel bisulfate market analysis.
2. FDA. (2022). Drug patent expiration dates.
3. IQVIA. (2023). Global pharmaceutical market insights.
4. European Medicines Agency. (2022). New drug approvals.
5. Reuters. (2022). Patent and market exit for Plavix.