TEDIZOLID PHOSPHATE - Generic Drug Details

What are the generic sources for tedizolid phosphate and what is the scope of patent protection?

Tedizolid phosphate is the generic ingredient in one branded drug marketed by Cubist Pharms Llc and is included in two NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tedizolid phosphate has seventy-nine patent family members in thirty-nine countries.

Two suppliers are listed for this compound.

Summary for TEDIZOLID PHOSPHATE

International Patents:	79
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	16
What excipients (inactive ingredients) are in TEDIZOLID PHOSPHATE?	TEDIZOLID PHOSPHATE excipients list
DailyMed Link:	TEDIZOLID PHOSPHATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TEDIZOLID PHOSPHATE

Constraining patent/regulatory exclusivity:

8,426,389

Dosage:

POWDER;INTRAVENOUS

Constraining patent/regulatory exclusivity:

8,426,389

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TEDIZOLID PHOSPHATE

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

Sponsor	Phase
Merck Sharp & Dohme LLC	PHASE1
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Phase 2
Los Angeles Biomedical Research Institute	Phase 2

See all TEDIZOLID PHOSPHATE clinical trials

Pharmacology for TEDIZOLID PHOSPHATE

Drug Class	Oxazolidinone Antibacterial
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for TEDIZOLID PHOSPHATE

J01XX	Other antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for TEDIZOLID PHOSPHATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435-001	Jun 20, 2014		RX	Yes	Yes	8,420,676		Y	Y
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436-001	Jun 20, 2014		RX	Yes	Yes	7,816,379		Y	Y
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436-001	Jun 20, 2014		RX	Yes	Yes	9,624,250		Y	Y

EU/EMA Drug Approvals for TEDIZOLID PHOSPHATE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Sivextro	tedizolid phosphate	EMEA/H/C/002846Sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and adolescents 12 years of age and older.	Authorised	no	no	no	2015-03-23

International Patents for TEDIZOLID PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
Singapore	173497	CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Philippines	12014500092	CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Japan	2007514737

Supplementary Protection Certificates for TEDIZOLID PHOSPHATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1699784	132016000024232	Italy		PRODUCT NAME: TEDIZOLID, FACOLTATIVAMENTE IN FORMA DI ESTERE, IN PARTICOLARE UN FOSFATO, O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(SIVEXTRO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/991/001, 20150325
1699784	675	Finland
1699784	122015000078	Germany		PRODUCT NAME: TEDIZOLID, GEGEBENENFALLS IN FORM EINES ESTERS, INSBESONDERE EINES PHOSPHATS, ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/15/991/001-003 20150323

Market Dynamics and Financial Trajectory for Tedizolid Phosphate

Last updated: July 28, 2025

Introduction

Tedizolid phosphate is a novel oxazolidinone-class antibiotic approved for treating acute bacterial skin and skin structure infections (ABSSSI). Developed by active pharmaceutical ingredient (API) innovators, its market performance hinges upon antimicrobial resistance trends, regulatory pathways, clinical efficacy, and competitive landscape. This analysis explores the evolving market dynamics and forecasted financial trajectory of Tedizolid phosphate within the global antibiotics market, emphasizing key drivers, challenges, and strategic considerations influencing its commercial prospects.

Market Landscape and Therapeutic Significance

The global antibiotics market is projected to reach approximately $50 billion by 2027, driven by rising antimicrobial resistance (AMR), increased healthcare spending, and a growing prevalence of bacterial infections [1]. Tedizolid phosphate, marketed notably under the brand name Sivextro, is positioned within this landscape as a second-generation oxazolidinone offering advantages over linezolid, including improved tolerability and a once-daily dosing regimen.

The primary target indication, ABSSSI, accounts for a significant share within the antibiotics market, projected to grow at a compounded annual growth rate (CAGR) of around 3.5% [2]. Although Tedizolid faces competition from established agents such as linezolid, daptomycin, and newer agents like delafloxacin, its enhanced safety profile and efficacy against resistant strains foster clinical acceptance and expansion opportunities.

Regulatory and Clinical Adoption Dynamics

The FDA approved Tedizolid phosphate in 2014, with subsequent approvals in Europe and other regions. Regulatory bodies have recognized its efficacy against resistant Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). The drug’s once-daily oral and intravenous formulations facilitate outpatient management, improving adherence and reducing hospital stays—factors that positively impact its uptake.

Clinical guidelines increasingly incorporate Tedizolid for ABSSSI, especially in patients intolerant to linezolid or requiring shorter therapy durations. Real-world data affirm its safety advantage—lower risk of hematologic side effects—further bolstering prescriber confidence.

Market Drivers

1. Rising Antimicrobial Resistance (AMR): The escalation of resistant pathogens necessitates novel agents. Tedizolid's activity against resistant strains grants it a competitive edge in complicated infections, especially MRSA, fostering sustained demand growth.

2. Regulatory Approvals and Expanding Indications: Ongoing clinical trials investigating Tedizolid's efficacy in gram-positive pneumonia, osteomyelitis, and other infections could broaden its application spectrum, translating into increased sales.

3. Healthcare Infrastructure and Outpatient Initiatives: The convenience of oral dosing aligns with shifting outpatient care trends, reducing hospitalization costs and expanding market reach.

4. Pricing Strategies and Reimbursement Policies: Favorable reimbursement frameworks in developed markets, coupled with tiered pricing in emerging economies, influence revenue streams.

Market Challenges

• Competition from Existing Agents: Linezolid, daptomycin, and newer antibiotics maintain substantial market share, limiting Tedizolid's incremental growth unless differentiated by clinical outcomes or pricing.

• Patent and Pricing Concerns: Patents expiring in the coming years threaten generic competition, potentially eroding profit margins. Additionally, high pricing strategies face resistance from payers seeking cost-effective alternatives.

• Microbial Evolution and Resistance Development: The potential for bacteria to develop resistance to Tedizolid, as observed with other antibiotics, underscores the need for cautious stewardship and limits rapid market expansion.

• Regulatory Hurdles in Emerging Markets: Navigating approvals in diverse geographies, with varying regulatory standards, poses a significant barrier to global penetration.

Financial Trajectory and Revenue Forecasts

The financial outlook for Tedizolid phosphate indicates moderate but steady growth over the next five years:

• Current Market Share and Revenue: Since its launch, Tedizolid has captured an estimated 5-8% of the ABSSSI segment in key markets like the U.S. and Europe, translating roughly to $150–$250 million annually [3].

• Growth Projections: Driven by expanding indications, clinical adoption, and emerging markets, analysts project a CAGR of approximately 4-6% from 2023 to 2028. Revenues could approach $350–$400 million globally by 2028 with conservative market penetration assumptions.

• Impact of Patent Expirations: Patent cliffs scheduled around 2027 could result in sharp revenue declines unless generics or biosimilars enter the market, emphasizing the need for lifecycle management strategies like indication expansion and formulation optimization.

• In-Development and Adjacent Markets: Clinical trials investigating Tedizolid for pneumonia and osteomyelitis could contribute incremental revenues if approved, diversifying income streams.

Strategic Considerations

• Partnerships and Licensing Agreements: To augment market penetration, especially across emerging markets, collaborations with regional pharmaceutical companies are vital.

• Formulation and Delivery Innovation: Developing extended-release formulations or fixed-dose combinations may enhance compliance and market differentiation.

• Pricing and Reimbursement Negotiations: Tailoring value propositions to healthcare payers ensures continued reimbursement and market access.

• Lifecycle Management: Extending patent protection and expanding indications prevents revenue erosion and maintains profitability.

Conclusion

Tedizolid phosphate's market dynamics are shaped by its clinical advantages, resistance management, and evolving healthcare models emphasizing outpatient treatment. While facing competition from entrenched antibiotics, its facilitative dosing regimen, superior safety profile, and increasing resistance crisis support steady growth prospects. The financial trajectory indicates modest but resilient revenue gains, contingent upon strategic expansion, lifecycle management, and navigating patent landscapes. Continuous clinical research and market adaptation are essential for sustaining its position in the competitive global antibiotics market.

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Key Takeaways

• Tedizolid phosphate remains a promising agent within the escalating antibiotics market, driven by its efficacy against resistant bacteria and favorable safety profile.

• Market growth will largely hinge on expanding clinical indications, regulatory approvals, and strategic partnerships, especially in emerging economies.

• Patent expirations pose significant threats; proactive lifecycle management is critical for sustained profitability.

• Competitive pressures from established antibiotics necessitate differentiation through clinical outcomes, pricing, and formulation advancements.

• The ongoing global combat against antimicrobial resistance creates a conducive environment for Tedizolid’s adoption, with projected revenues approaching $400 million by 2028.

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FAQs

1. What are the key advantages of Tedizolid phosphate over linezolid?
Tedizolid offers a once-daily oral and IV dosing regimen, improved safety profile with lower risks of hematologic toxicity, and greater potency against certain resistant strains, enhancing patient compliance and reducing adverse events.

2. How does antimicrobial resistance impact Tedizolid’s market prospects?
The rise of resistant Gram-positive bacteria, especially MRSA, sustains demand for advanced antibiotics like Tedizolid. Its activity against resistant strains positions it favorably, although emerging resistance could eventually limit its efficacy if not managed appropriately.

3. What role do regulatory approvals play in Tedizolid’s financial trajectory?
Regulatory approvals facilitate market entry and segment expansion. Approvals in multiple regions broaden geographic reach, directly influencing sales volumes and revenue growth.

4. How will patent expirations affect Tedizolid’s future revenues?
Patent cliffs scheduled around 2027 could lead to generic competition, significantly reducing prices and sales unless the manufacturer introduces new formulations or indications to extend market exclusivity.

5. What strategic moves can maximize Tedizolid’s market share?
Formulating strategic collaborations, expanding indications through clinical trials, investing in formulation improvements, and engaging in proactive pricing and reimbursement negotiations are key to capturing greater market share.

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References

1. Global Antibiotics Market Report, 2022-2027, Research and Markets.
2. ABSSSI Treatment Trends, 2022, CDC Infectious Disease Reports.
3. Tedizolid Market Analysis and Forecast, 2023, EvaluatePharma.