ZYVOX Drug Patent Profile

When do Zyvox patents expire, and what generic alternatives are available?

Zyvox is a drug marketed by Pfizer and is included in three NDAs.

The generic ingredient in ZYVOX is linezolid. There are twenty-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the linezolid profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Zyvox

A generic version of ZYVOX was approved as linezolid by HIKMA on June 3^rd, 2015.

Summary for ZYVOX

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	121
Patent Applications:	4,240
Drug Prices:	Drug price information for ZYVOX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ZYVOX
What excipients (inactive ingredients) are in ZYVOX?	ZYVOX excipients list
DailyMed Link:	ZYVOX at DailyMed

See drug prices for ZYVOX

Pharmacology for ZYVOX

Drug Class

Oxazolidinone Antibacterial

Paragraph IV (Patent) Challenges for ZYVOX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZYVOX	Injection	linezolid	2 mg/mL, 100 mL bag	021131	1	2009-12-29
ZYVOX	Injection	linezolid	2 mg/mL, 300 mL bag	021131	1	2009-09-01
ZYVOX	Oral Suspension	linezolid	100 mg/5 mL	021132	1	2009-08-03
ZYVOX	Tablets	linezolid	600 mg	021130	1	2005-12-21

US Patents and Regulatory Information for ZYVOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	ZYVOX	linezolid	FOR SUSPENSION;ORAL	021132-001	Apr 18, 2000	AB	RX	Yes	Yes
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-003	Apr 18, 2000	AP	RX	Yes	Yes
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-001	Apr 18, 2000	AP	RX	Yes	No
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-002	Apr 18, 2000		DISCN	Yes	No
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-002	Apr 18, 2000	AB	RX	Yes	Yes

Expired US Patents for ZYVOX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-002	Apr 18, 2000
Pfizer	ZYVOX	linezolid	SOLUTION;INTRAVENOUS	021131-002	Apr 18, 2000
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-001	Apr 18, 2000
Pfizer	ZYVOX	linezolid	FOR SUSPENSION;ORAL	021132-001	Apr 18, 2000
Pfizer	ZYVOX	linezolid	TABLET;ORAL	021130-001	Apr 18, 2000

International Patents for ZYVOX

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

Country	Patent Number	Title	Estimated Expiration
Spain	2139093
South Korea	20070094673
Ecuador	SP013979	FORMULACIÓN DE TABLETAS DE OXAZOLIDINONA
Slovenia	1255754
Norway	20065836

Supplementary Protection Certificates for ZYVOX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0717738	PA2004004	Lithuania		PRODUCTNAME: LINEZOLIDUM - (S)-N-[[3-FLUOR-4-(4-MORFOLINIL)FENIL]-2-OKSO-5-OKSAZOLIDINIL]METIL]-ACETAMIDAS
0717738	SPC/GB01/025	United Kingdom		PRODUCT NAME: LINEZOLID; REGISTERED: UK PL 00032/0259 20010105; UK PL 00032/0260 20010105; UK PL 00032/0261 20010105; UK PL 00032/0262 20010105
0717738	CA 2002 00004	Denmark
0717738	02C0005	France		PRODUCT NAME: LINEZOLIDE; NAT. REGISTRATION NO/DATE: NL 26 660 20010831; FIRST REGISTRATION: GB - PL 00 32/0261 20010105
0717738	SPC001/2002	Ireland		SPC001/2002: 20031204, EXPIRES: 20160104

ZYVOX Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: ZYVOX (Linezolid)

Introduction

ZYVOX, known generically as linezolid, is a potent antibiotic belonging to the oxazolidinone class, primarily used to treat serious Gram-positive infections. This article delves into the market dynamics and financial trajectory of linezolid, highlighting its current market position, future projections, and the factors influencing its growth.

Market Size and Forecast

The global linezolid drug market is anticipated to grow at a Compound Annual Growth Rate (CAGR) of 3 to 5% from 2024 to 2031. This growth is driven by the increasing incidence of Gram-positive infections, including those caused by multidrug-resistant pathogens such as MRSA and vancomycin-resistant Enterococcus (VRE)[1].

Segmentation and Applications

The linezolid market is segmented based on application, product form, and geographical regions. Key applications include:

• Hospital Acquired Pneumonia (HAP)
• Community Acquired Pneumonia (CAP)
• Complex Skin or Skin Soft Tissue Infections (SSTI)
• Vancomycin-Resistant Enterococcus (VRE) Infection
• Other infections

The drug is available in two primary forms: injections and tablets. Geographically, the market spans North America, Europe, Asia-Pacific, South America, and the Middle East & Africa[1].

Regional Insights

The Asia-Pacific region is expected to play a significant role in the growth of the linezolid market, similar to the broader antibiotics market. This region accounted for the highest market share in 2023, driven by advanced healthcare infrastructure, government initiatives, and the availability of low-cost generic antibiotics[3].

Key Companies and Market Players

Several major pharmaceutical companies are involved in the production and distribution of linezolid. These include:

• Pfizer
• Fresenius
• Auro Pharma
• TEVA
• Panda Pharmaceuticals
• ZHENGDA Tianqing Pharmaceutical Group
• Jamp Pharma
• Jiangsu Haosen Pharmaceutical Group
• Sandoz (Novartis)[1].

Cost and Pricing Dynamics

The cost of linezolid can vary significantly based on factors such as treatment plan, insurance coverage, and the pharmacy used. Linezolid is available as both a generic and the brand-name drug Zyvox. The price comparison between linezolid and other antibiotics like vancomycin depends on the form of the drug, treatment length, and payment assistance programs[2].

Financial Impact of Linezolid

Despite its higher acquisition cost compared to vancomycin, linezolid can offer cost savings through reduced hospital stay lengths and lower total hospitalization costs. Pharmacoeconomic analyses indicate that linezolid has a favorable incremental cost-effectiveness ratio, particularly for patients with ventilator-associated pneumonia[4].

Market Drivers

Several factors drive the growth of the linezolid market:

• Increasing Incidence of Gram-Positive Infections: The rise in infections caused by multidrug-resistant pathogens necessitates the use of effective antibiotics like linezolid.
• Economic Growth and Antibiotic Consumption: Economic prosperity in developing countries has enhanced access to antibiotics, contributing to increased consumption[3].
• Advantages Over Other Antibiotics: Linezolid's oral bioavailability and ability to be administered sequentially from intravenous to oral without changing the dosage regimen make it a preferred option in certain clinical scenarios[4].

Market Challenges

Despite the growth potential, the linezolid market faces several challenges:

• High Development Costs: The development of new antibiotics is a lengthy and expensive process, often resulting in high failure rates and limited market opportunities[3].
• Antibiotic Resistance: The sparing use of new antibiotics to mitigate resistance development can limit their market growth and profitability[3].

Competitive Landscape

The antibiotics market, including linezolid, is highly competitive with several key players. The market is characterized by the presence of both branded and generic products, with companies like Pfizer, Abbott Laboratories, and GlaxoSmithKline playing significant roles[3].

Pharmacoeconomic Considerations

Linezolid's pharmacoeconomic profile is favorable in certain patient subgroups. It offers advantages such as reduced hospital stay lengths and lower total hospitalization costs, which can offset its higher acquisition cost. For example, modelled analyses indicate that linezolid has a favorable incremental cost-effectiveness ratio of approximately $30,000 per Quality-Adjusted Life Year (QALY) gained for patients with ventilator-associated pneumonia[4].

Future Outlook

The future outlook for the linezolid market is positive, driven by the increasing need for effective treatments against Gram-positive infections. The Asia-Pacific region is expected to continue its dominance, and advancements in healthcare infrastructure and government initiatives will further boost the market.

Key Takeaways

• Market Growth: The linezolid market is expected to grow at a CAGR of 3 to 5% from 2024 to 2031.
• Segmentation: The market is segmented by application, product form, and geographical regions.
• Regional Dominance: Asia-Pacific is expected to dominate the market due to advanced healthcare infrastructure and government initiatives.
• Cost-Effectiveness: Linezolid offers cost savings through reduced hospital stay lengths and lower total hospitalization costs despite its higher acquisition cost.
• Market Drivers: Increasing incidence of Gram-positive infections and economic growth in developing countries drive the market.

FAQs

What are the primary applications of linezolid?

Linezolid is primarily used to treat serious Gram-positive infections, including Hospital Acquired Pneumonia (HAP), Community Acquired Pneumonia (CAP), Complex Skin or Skin Soft Tissue Infections (SSTI), and Vancomycin-Resistant Enterococcus (VRE) Infection.

How does the cost of linezolid compare with other antibiotics?

The cost of linezolid can vary based on factors like treatment plan, insurance coverage, and pharmacy used. Despite its higher acquisition cost, linezolid can offer cost savings through reduced hospital stay lengths and lower total hospitalization costs.

What are the key companies involved in the production of linezolid?

Key companies involved include Pfizer, Fresenius, Auro Pharma, TEVA, Panda Pharmaceuticals, ZHENGDA Tianqing Pharmaceutical Group, Jamp Pharma, Jiangsu Haosen Pharmaceutical Group, and Sandoz (Novartis).

What are the advantages of linezolid over other antibiotics?

Linezolid offers advantages such as high oral bioavailability, allowing sequential intravenous-to-oral administration without changing the dosage regimen, and it is particularly useful in patients with impaired renal function or poor intravenous access.

How does the Asia-Pacific region influence the linezolid market?

The Asia-Pacific region dominates the linezolid market due to its advanced healthcare infrastructure, government initiatives, and the availability of low-cost generic antibiotics, making it a significant driver of market growth.

Sources

1. Market Research Intellect, "Global Linezolid Drug Market Size and Forecast," December 2024.
2. MedicalNewsToday, "Linezolid cost 2024: Coupons and more," November 14, 2023.
3. Biospace, "Antibiotics Market Size to Reach USD 85.80 Billion by 2033," May 24, 2024.
4. PubMed, "Linezolid: a pharmacoeconomic review of its use in serious Gram-positive infections," 2005.
5. ACS Omega, "Overcoming Mycobacterium tuberculosis Drug Resistance: Novel Approaches," August 31, 2023.