ZOCOR Drug Patent Profile

Which patents cover Zocor, and when can generic versions of Zocor launch?

Zocor is a drug marketed by Organon and is included in one NDA.

The generic ingredient in ZOCOR is simvastatin. There are forty drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the simvastatin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zocor

A generic version of ZOCOR was approved as simvastatin by AUROBINDO PHARMA on December 20^th, 2006.

Summary for ZOCOR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	113
Drug Prices:	Drug price information for ZOCOR
What excipients (inactive ingredients) are in ZOCOR?	ZOCOR excipients list
DailyMed Link:	ZOCOR at DailyMed

See drug prices for ZOCOR

See drug sales revenues for ZOCOR

Pharmacology for ZOCOR

Drug Class	HMG-CoA Reductase Inhibitor
Mechanism of Action	Hydroxymethylglutaryl-CoA Reductase Inhibitors

US Patents and Regulatory Information for ZOCOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-001	Dec 23, 1991	AB	RX	Yes	No
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-004	Dec 23, 1991	AB	RX	Yes	No
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-002	Dec 23, 1991	AB	RX	Yes	No
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-003	Dec 23, 1991	AB	RX	Yes	No
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-005	Jul 10, 1998		DISCN	Yes	No

Expired US Patents for ZOCOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-004	Dec 23, 1991
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-005	Jul 10, 1998
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-002	Dec 23, 1991
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-003	Dec 23, 1991
Organon	ZOCOR	simvastatin	TABLET;ORAL	019766-001	Dec 23, 1991

International Patents for ZOCOR

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0033538	6(R)-(2-(8'-ACYLOXY-2'-METHYL-6'-METHYL (OR HYDROGEN)-POLYHYDRONAPHTHYL-1')-ETHYL)-4(R)-HYDROXY-3,4,5,6-TETRAHYDRO-2H-PYRAN-2-ONES, THE HYDROXY ACID FORM OF SAID PYRANONES, THE PHARMACEUTICALLY ACCEPTABLE SALTS OF SAID HYDROXY ACIDS, AND THE LOWER ALKYL, AND PHENYL, DIMETHYLAMINO OR ACETYLAMINO SUBSTITUTED LOWER ALKYL ESTERS OF SAID HYDROXY ACID, PROCESSES FOR PREPARING THE SAME, AND A PHARMACEUTICAL ANTIHYPERCHOLESTEROLEMIC COMPOSITION CONTAINING THE SAME
Canada	1307263	INHIBITEURS DE LA HMG-COA REDUCTASE (HMG-COA REDUCTASE INHIBITORS)
Germany	3869282
Ecuador	SP941119	COMPUESTOS ANTIHIPERCOLESTEROLEMICOS
Bulgaria	61418

Supplementary Protection Certificates for ZOCOR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	26/2005	Austria		PRODUCT NAME: EZETIMIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON KOMBINIERT MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 1-25673 - 1-25676 20041228; FIRST REGISTRATION: DE 58874.00.00 - 58874.03.00; 58878.00.00 - 20040402
0720599	C300172	Netherlands		PRODUCT NAME: EZETIMIBE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, EN SIMVASTATINE; NAT. REGISTRATION NO/DATE: RVG 30927RVG 30928RVG 30929RVG 30930 2004221122; FIRST REGISTRATION: 58874.00.0058874.01.0058874.02.0058874.03.0058878.00.0058878.01.0058878.02.0058878.03.0058866.00.0058866.01.0058866.02.0058866.03.0058870.00.0058870.01.0058870.02.0058870.03.00 2004020402
0033538	SPC/GB93/005	United Kingdom
0720599	05C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599	122004000026	Germany		PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT SIMVASTATIN; NAT. REGISTRATION NO/DATE: 58866.00.00 58866.01.00 58866.02.00 58866.03.00 58870.00.00 58870.01.00 58870.02.00 58870.03.00 58874.00.00 58874.01.00 58874.02.00 58874.03.00 58878.00.00 58878.01.00 58878.02.00 58878.03.00 20040402 FIRST REGISTRATION: DE 58866.00.00 - 58866.03.00 58870.00.00 - 58870.03.00 58874.00.00 - 58874.03.00 58878.00.00 - 58878.03.00 20040402

ZOCOR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: ZOCOR

Introduction

ZOCOR, known generically as simvastatin, is a widely used statin for managing high cholesterol and reducing the risk of cardiovascular diseases. This article delves into the market dynamics and financial trajectory of ZOCOR, exploring its historical performance, current market trends, and future projections.

Historical Context of ZOCOR

ZOCOR, developed by Merck, was one of the top-selling medicines globally before losing its patent protection. The drug's success was unprecedented, with sales peaking in the early 2000s. However, the expiration of its patent marked a significant turning point in its market dynamics[4].

Impact of Generic Entry

The introduction of generic simvastatin had a profound impact on the market. After losing patent protection, the number of brand-name ZOCOR purchases plummeted. For instance, between 2002 and 2018, the number of brand-name statin purchases, including ZOCOR, decreased by 90.9% nationally and 27.4% individually after the end of market exclusivity. This shift was accompanied by a substantial drop in annual expenditures, reflecting the cost-effectiveness of generic alternatives[4].

Market Share and Revenue

Before the generic entry, ZOCOR commanded a significant market share. However, post-patent expiration, its market share dwindled dramatically. For example, Zocor's global sales were down 14% to $990 million in the second quarter of 2006, just after losing patent protection. This decline was a result of patients switching to generic simvastatin, which offered the same efficacy at a lower cost[5].

Current Market Trends

Despite the decline in brand-name sales, simvastatin remains a crucial drug in the cholesterol management market. Here are some key trends:

Regional Growth

The global simvastatin market is expected to grow at a compound annual growth rate (CAGR) of 5.2% from 2024 to 2031. North America, led by the United States, continues to be a major market, driven by the high prevalence of lifestyle-related diseases and robust healthcare infrastructure. The Asia Pacific region, however, is the fastest-growing market, with a CAGR of 6.6%, driven by increasing awareness about heart health and improving healthcare infrastructure[1].

Demographic Focus

The adult demographic is the primary segment driving the growth of simvastatin in most regions. Increasing urbanization, dietary shifts, and stressful lifestyles have elevated cholesterol-related concerns among adults, making this segment critical for the market's sustained growth[1].

Financial Performance

The financial performance of simvastatin is closely tied to its market dynamics. Here are some key financial insights:

Revenue Projections

The global simvastatin market is projected to expand significantly, with North America contributing a substantial 40% market share. The Asia Pacific region, with its rapid growth, is expected to play a crucial role in the market's financial trajectory[1].

Cost and Pricing Dynamics

The entry of generic simvastatin has significantly impacted pricing dynamics. Generic drugs capture a large share of the market due to their cost-effectiveness. This has led to a reduction in overall expenditures on statins. For instance, the annual expenditures on Crestor, another statin, dropped from $8.79 billion in 2014 to $0.61 billion in 2018 after the introduction of generic rosuvastatin[4].

Role of Intermediaries

Pharmacy Benefit Managers (PBMs) play a crucial role in drug pricing and market dynamics. They influence the formulary inclusion of drugs and can significantly reduce expenditures by excluding certain drugs from insurance coverage. However, their ability to capture a fraction of the savings can impact the overall cost-effectiveness of drug treatments[3].

Future Projections

The simvastatin market is poised for continued growth, driven by several factors:

Increasing Demand

The rising prevalence of cardiovascular diseases and the need for effective cholesterol management solutions will continue to drive demand for simvastatin. The adult demographic, particularly in regions like Asia Pacific, will remain a key driver of this growth[1].

Healthcare Infrastructure

Improving healthcare infrastructure and increasing awareness about heart health will further boost the market. Robust diagnostic capabilities and a proactive approach to managing chronic conditions will also contribute to the sustained growth of the simvastatin market[1].

Competitive Landscape

The market will continue to be competitive, with generic simvastatin playing a dominant role. Newer drugs and innovative formulations may also enter the market, but the affordability and efficacy of simvastatin will ensure its continued relevance[5].

Key Takeaways

• Generic Entry Impact: The introduction of generic simvastatin significantly reduced brand-name sales and expenditures.
• Regional Growth: North America and Asia Pacific are key regions driving the growth of the simvastatin market.
• Demographic Focus: The adult demographic is the primary segment driving market growth.
• Financial Performance: The market is expected to grow at a CAGR of 5.2% from 2024 to 2031, driven by increasing demand and improving healthcare infrastructure.
• Pricing Dynamics: PBMs play a crucial role in pricing and cost-effectiveness.

FAQs

What was the impact of generic entry on ZOCOR sales?

The introduction of generic simvastatin led to a 90.9% national decrease and a 27.4% individual decrease in brand-name ZOCOR purchases after the end of market exclusivity[4].

Which regions are driving the growth of the simvastatin market?

North America, particularly the United States, and the Asia Pacific region are the key drivers of the simvastatin market growth[1].

How do Pharmacy Benefit Managers (PBMs) influence the simvastatin market?

PBMs influence the market by excluding certain drugs from insurance coverage, reducing expenditures, and capturing a fraction of the savings. They play a crucial role in pricing and cost-effectiveness[3].

What is the projected CAGR for the global simvastatin market from 2024 to 2031?

The global simvastatin market is expected to grow at a CAGR of 5.2% from 2024 to 2031[1].

Which demographic segment is primarily driving the growth of the simvastatin market?

The adult demographic is the primary segment driving the growth of the simvastatin market, particularly in regions like Asia Pacific[1].

Sources

1. Cognitive Market Research: Simvastatin Drug Market Report 2024 (Global Edition)
2. AstraZeneca: FY and Q4 2023 results Strong growth and pipeline momentum
3. Josh Feng: Explaining Prescription Drug Pricing Dynamics
4. JAMA Network Open: Use and Expenditures for Brand-name Statins After Introduction of Generic Statins
5. C&EN - American Chemical Society: Life After Zocor