PLAVIX Drug Patent Profile

Which patents cover Plavix, and what generic alternatives are available?

Plavix is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in PLAVIX is clopidogrel bisulfate. There are fifty-four drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the clopidogrel bisulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Plavix

A generic version of PLAVIX was approved as clopidogrel bisulfate by DR REDDYS on January 14^th, 2008.

Summary for PLAVIX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	222
Patent Applications:	2,900
Drug Prices:	Drug price information for PLAVIX
Drug Sales Revenues:	Drug sales revenues for PLAVIX
What excipients (inactive ingredients) are in PLAVIX?	PLAVIX excipients list
DailyMed Link:	PLAVIX at DailyMed

See drug prices for PLAVIX

See drug sales revenues for PLAVIX

Recent Clinical Trials for PLAVIX

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

Sponsor	Phase
Pakistan Chest Society, Pakistan	Phase 3
Lady Reading Hospital, Pakistan	Phase 3
ClinPharmInvest, LLC	Phase 1

See all PLAVIX clinical trials

Pharmacology for PLAVIX

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

Paragraph IV (Patent) Challenges for PLAVIX

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 PLAVIX

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
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-002	Sep 20, 2007	AB	RX	Yes	No

Expired US Patents for PLAVIX

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	6,504,030*PED
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-001	Nov 17, 1997	4,529,596
Sanofi Aventis Us	PLAVIX	clopidogrel bisulfate	TABLET;ORAL	020839-002	Sep 20, 2007	6,429,210*PED

International Patents for PLAVIX

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

Country	Patent Number	Title	Estimated Expiration
Canada	2334870	FORME POLYMORPHE DE L'HYDROGENOSULFATE DE CLOPIDOGREL (POLYMORPHIC FORM OF CLOPIDOGREL HYDROGEN SULPHATE)
Slovakia	286340
Algeria	558	Nouveaux dérivés de la thiéno (3,2-c) pyridine, leur procédé de préparation et leur application thérapeutique.

Supplementary Protection Certificates for PLAVIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0281459	98C0036	France		PRODUCT NAME: CLOPIDOGREL HYDROGENE SULFATE; REGISTRATION NO/DATE IN FRANCE: EU/1/98 /069/001 DU 19980715; REGISTRATION NO/DATE AT EEC: DU EU/1-/98/069/001
0281459	SPC/GB99/001	United Kingdom		PRODUCT NAME: CLOPIDOGREL HYDROGEN SULPHATE, THE DEXTROROTATORY ISOMER OF ALPHA-(4,5,6,7-TETRAHYDROTHIENO(3,2-C)PYRID-5-YL)(2-CHLOROPHENYL) METHYL ACETATE AS THE HYDROGEN SULPHATE SALT; REGISTERED: UK EU/1/98/069/001 19980715; UK EU/1/98/069/002 19980715; UK EU/1/98/069/003 19980715
0281459	C990002	Netherlands		PRODUCT NAME: CLOPIDOGREL WATERSTOFSULFAAT; REGISTRATION NO/DATE: EU 1/98/069/001 - EU 1/98/069/003 19980715

PLAVIX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: Plavix

Introduction

Plavix, known generically as clopidogrel, is a widely used antiplatelet medication that has been a cornerstone in the prevention of strokes and heart attacks. Here, we delve into the market dynamics and financial trajectory of Plavix, exploring its historical performance, current challenges, and future outlook.

Historical Performance of Plavix

Peak Sales and Patent Expiry

Plavix, developed and marketed by Sanofi and Bristol Myers Squibb (BMS), was one of the most successful drugs in the early 2000s. In 2007, Plavix drove significant growth for BMS, with pharmaceutical sales increasing by 24% year-over-year, largely due to a 42% growth in U.S. sales and a 99% increase in international sales[2].

However, the patent for Plavix expired in May 2012, which led to a sharp decline in global sales. The entry of generic versions post-patent expiry reduced the overall profitability of the market, although the demand for clopidogrel remained robust[1][4].

Market Share and Sales

Global Sales Figures

At its peak, Plavix was a blockbuster drug, with global sales reaching $2.3 billion in 2013. Despite the decline following patent expiry, Plavix remained a significant player in the anti-thrombotic drug market. Anti-platelet drugs, led by clopidogrel, accounted for 40.4% of all anti-thrombotic drug sales, with a global market size of $9.5 billion[1].

Current Sales Performance

In recent years, Plavix has continued to generate revenue, albeit at a lower level. For instance, in the second quarter of 2024, Plavix sales were €235 million, representing a 2.1% increase, primarily driven by use in the Rest of World markets[5].

Challenges Facing Plavix

Supply Chain Disruptions and Price Increases

The pharmaceutical industry, including the market for clopidogrel, has faced significant challenges due to global supply chain disruptions, soaring demand, and escalating production costs. The cost of raw materials and energy, along with higher labor costs, has led to a notable increase in the prices of clopidogrel bisulfate, the active pharmaceutical ingredient (API) in Plavix. This has been exacerbated by freight cost increases and ongoing disruptions from the COVID-19 pandemic[3].

Genetic Limitations and FDA Warnings

Clopidogrel has genetic limitations, particularly for patients with CYP2C19 gene mutations, which affects its metabolism. This has led to a black-box warning from the FDA, highlighting a potential reduction in efficacy for these patients[1].

Market Trends and Future Outlook

Growing Demand for Antiplatelet Medications

The demand for clopidogrel is expected to continue growing due to an aging population and an increasing prevalence of cardiovascular diseases globally. Emerging economies in the Asia Pacific region, such as China, India, and Japan, are anticipated to be major consumers of clopidogrel in the coming years[4].

Geographical Outlook

North America and Europe currently contribute to the maximum demand for clopidogrel, driven by robust healthcare infrastructure and high affordability. However, the Asia Pacific region is expected to play a significant role in the future, given its large patient base and improving healthcare sector[4].

Competitive Landscape

The anti-thrombotic drug market is evolving with the introduction of new direct thrombin inhibitors and direct coagulation factor Xa inhibitors. These new drugs pose a challenge to the dominance of anti-platelet drugs like clopidogrel, potentially altering the market dynamics in the future[1].

Financial Impact on Manufacturers

Revenue and Profitability

The financial performance of manufacturers like Sanofi and BMS has been impacted by the changes in the Plavix market. While Plavix continues to contribute to their revenue, the decline in sales post-patent expiry has reduced overall profitability. Sanofi's Q2 2024 report showed a modest increase in Plavix sales, but this was overshadowed by the strong performance of other drugs like Dupixent[5].

Cost and Pricing Pressures

The rising costs of raw materials, production, and freight have forced manufacturers to increase the prices of clopidogrel bisulfate, which can affect their market share and profitability. The industry is calling for greater transparency in pricing mechanisms and supply chain processes to mitigate future price volatility[3].

Key Takeaways

• Historical Success: Plavix was a blockbuster drug with peak sales of $2.3 billion in 2013.
• Post-Patent Decline: Sales declined sharply after the patent expired in 2012, but the drug remains significant in the anti-thrombotic market.
• Current Challenges: Supply chain disruptions, increasing production costs, and genetic limitations affect the market.
• Growing Demand: The demand for clopidogrel is expected to grow due to an aging population and increasing cardiovascular diseases.
• Geographical Shifts: The Asia Pacific region is becoming a key market for clopidogrel.
• Competitive Landscape: New drugs are challenging the dominance of anti-platelet medications.

FAQs

What was the impact of the patent expiry on Plavix sales?

The patent expiry of Plavix in May 2012 led to a sharp decline in global sales due to the entry of generic versions.

Why are clopidogrel bisulfate prices increasing?

Prices are increasing due to global supply chain disruptions, soaring demand, escalating production costs, and higher freight costs.

What are the genetic limitations of clopidogrel?

Clopidogrel has limitations for patients with CYP2C19 gene mutations, which affects its metabolism and has led to an FDA black-box warning.

Which regions are expected to drive future demand for clopidogrel?

The Asia Pacific region, particularly countries like China, India, and Japan, are expected to be major consumers of clopidogrel in the coming years.

How are new drugs affecting the market for Plavix?

New direct thrombin inhibitors and direct coagulation factor Xa inhibitors are posing a challenge to the dominance of anti-platelet drugs like clopidogrel.

Sources

1. Fan, Recent progress and market analysis of anticoagulant drugs, Journal of Thoracic Disease, 2023.
2. S&P Global, Strong Plavix Sales Growth Drives BMS's Q3 Net Profit, 2007.
3. ChemAnalyst, Clopidogrel Bisulfate Prices Continue to Soar with Supply-Demand Imbalance, 2024.
4. BioSpace, Clopidogrel Market Latest Trends and Future Growth Detailed Analysis to 2025, 2020.
5. Sanofi, Q2 2024 Financial Report, 2024.