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.

One supplier is listed for this compound.

Summary for TEDIZOLID PHOSPHATE

International Patents:	79
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
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	POWDER;INTRAVENOUS	205436-001	Jun 20, 2014		RX	Yes	Yes
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436-001	Jun 20, 2014		RX	Yes	Yes	8,426,389		Y	Y
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435-001	Jun 20, 2014		RX	Yes	Yes	9,988,406		Y
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435-001	Jun 20, 2014		RX	Yes	Yes	8,426,389		Y	Y
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435-001	Jun 20, 2014		RX	Yes	Yes	8,420,676		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
South Africa	201106412	CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
South Africa	201306536	CRYSTALLINE FORM OF R)-3-(4-(2-(2-METHYLTETRAZOL-5-YL)PYRIDIN-5-YL)-3-FLUOROPHENYL)-5-HYDROXYMETHYL OXAZOLIDIN-2-ONE DIHYDROGEN PHOSPHATE
Ecuador	SP11011285	FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTETRAZOL-5-IL)PIRIDIN-5-IL)-3-FLUOROFENIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA
Japan	5584705
Australia	2009200606	Novel oxazolidinone derivatives

Supplementary Protection Certificates for TEDIZOLID PHOSPHATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1699784	C 2015 035	Romania		PRODUCT NAME: TEDIZOLIDOPTIONAL SUB FORMA DE ESTER, IN PARTICULAR FOSFATUL SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/991; DATE OF NATIONAL AUTHORISATION: 20150323; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/991; DATE OF FIRST AUTHORISATION IN EEA: 20150323
1699784	15C0062	France		PRODUCT NAME: TEDIZOLIDE,EVENTUELLEMENT SOUS LA FORME D'UN ESTER ,EN PARTICULIER UN PHOSPHATE,OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/15/991 20150325
1699784	C300759	Netherlands		PRODUCT NAME: TEDIZOLID, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784	2015/048	Ireland		PRODUCT NAME: TEDIZOLID, OPTIONALLY IN THE FORM OF AN ESTER, IN PARTICULAR A PHOSPHATE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784	243 50021-2015	Slovakia		PRODUCT NAME: TEDIZOLIDFOSFAT; REGISTRATION NO/DATE: EU/1/15/991/001 - EU/1/15/991/003 20150325

Market Dynamics and Financial Trajectory for Tedizolid Phosphate

Last updated: March 4, 2026

What Is the Current Market Position of Tedizolid Phosphate?

Tedizolid phosphate is an oxazolidinone-class antibiotic approved by the U.S. Food and Drug Administration (FDA) in 2014. It is primarily indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Its approval marked its entry into a competitive segment dominated by drugs like linezolid.

Market Size and Segmentation

The global antibiotics market was valued at approximately USD 56 billion in 2022, with the oxazolidinone segment accounting for roughly 4% (USD 2.2 billion). Tedizolid's contribution remains limited due to its narrow approved indications and competition from established drugs.

Competitive Landscape

Tedizolid faces competition from:

• Linezolid (market share: 65% in gram-positive antibiotics)
• Dalbavancin and oritavancin (for similar infections)
• Other emerging antibiotics

Major companies include Pfizer, which markets the drug under the brand name Sivextro, and Teva, involved in generic versions.

What Are Key Drivers Affecting Market Dynamics?

Increasing Antibiotic Resistance

The rise of MRSA and other resistant pathogens sustains demand for novel antibiotics. Tedizolid's potent activity against resistant strains sustains some interest, but resistance development remains a risk, potentially limiting long-term sales.

Regulatory and Label Expansions

Regulatory agencies are scrutinizing new antibiotic approvals. Expanding indications or securing approval for additional infections could boost sales. However, as of 2023, no significant label expansions have occurred.

Pricing and Reimbursement Policies

The pricing of Tedizolid remains high, around USD 2,000 per week of therapy in the U.S., constrained by insurance reimbursement decisions. Cost-effectiveness compared with older drugs influences uptake.

Competition from Generics

Pfizer's patent exclusivity was challenged successfully in 2021, leading to generic versions. Price competition from generics substantially impacts margins and sales volume.

Prescriber Adoption and Healthcare Settings

Tedizolid's infusion and dosing advantages (once daily, shorter duration) favor outpatient and hospital use. Adoption rates depend on physician familiarity and clinical guidelines.

How Will Financial Trajectory Evolve?

Revenue Trends

In 2022, Pfizer's global sales of Sivextro were approximately USD 120 million, representing a decline from peak sales of USD 250 million in 2015.[1] The generics market's entry further suppresses sales.

Market Forecasts

Projections estimate the global tedizolid market will grow modestly at a compound annual growth rate (CAGR) of 3-4%, reaching USD 150-180 million by 2027, driven by resistance-driven demand but constrained by competition and generics.

Profitability Outlook

Gross margins are pressured by generic competition. R&D investments focus on new formulations and line extensions. Despite limited sales, companies continue to invest in pipeline development to sustain long-term profitability.

What Regulatory and Policy Trends Might Influence the Market?

• Active antimicrobial stewardship programs restrict prescribing to necessary cases.
• The U.S. FDA and EMA adopt stricter regulations for antibiotics akin to those for high-cost biologics.
• Incentive programs like the Priority Review Voucher can influence company investment strategies, although not specifically for tedizolid.

How Will Competitive and Innovation Activities Shape Future Prospects?

• Development of combination therapies incorporating tedizolid is underway, potentially broadening indications.
• Innovative delivery methods, such as oral formulations or long-acting injectables, could improve adoption.
• Ongoing research exploring efficacy against resistant pathogens may lead to label extensions.

Summary Table: Key Data Points

Factor	Details
Year of FDA Approval	2014
Approved Indication	ABSSSI, skin infections
Major Market Share (2015-2022)	Pfizer (Sivextro): USD 120M in global sales (2022)
Patent Status	Patent expired in 2021; generics available as of 2022
Estimated Market Size (2027)	USD 150-180M
CAGR (2023-2027)	3-4%

Key Takeaways

• Tedizolid phosphate's current sales are limited and declining due to patent expiration and generic competition.
• Market growth relies on resistance-driven demand and potential indication expansion.
• Pricing pressures and competitive dynamics hinder profitability.
• Long-term prospects depend on pipeline innovations and regulatory shifts.

FAQs

What factors most influence tedizolid's market growth?

Resistance to resistant gram-positive bacteria and regulatory developments are primary drivers. Competition from generics and shifts in prescribing patterns limit growth.

How does patent expiration impact sales?

Patent expiry in 2021 led to a reduction in pricing power due to generic competition, causing sales to decline and margins to compress.

Are there ongoing efforts to expand tedizolid’s indications?

Research explores uses against other resistant infections and combination therapies, but no approved new indications exist as of 2023.

What role do pricing and reimbursement policies play?

High drug prices limit adoption; payer restrictions and-based reimbursement criteria further constrain sales volume.

What is the outlook for companies investing in tedizolid?

Companies focus on pipeline diversification, including new formulations and combination therapies, aiming to offset stagnating sales.

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[1] Pfizer Inc. (2023). Annual Report 2022. Retrieved from https://www.pfizer.com/investors/financial-reports