SIVEXTRO Drug Patent Profile

When do Sivextro patents expire, and when can generic versions of Sivextro launch?

Sivextro is a drug marketed by Cubist Pharms Llc and is included in two NDAs. There are seven patents protecting this drug.

This drug has seventy-nine patent family members in thirty-nine countries.

The generic ingredient in SIVEXTRO is tedizolid phosphate. One supplier is listed for this compound. Additional details are available on the tedizolid phosphate profile page.

DrugPatentWatch^® Generic Entry Outlook for Sivextro

Sivextro was eligible for patent challenges on June 20, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 3, 2030. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for SIVEXTRO

International Patents:	79
US Patents:	7
Applicants:	1
NDAs:	2

US Patents and Regulatory Information for SIVEXTRO

SIVEXTRO is protected by seven US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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			Y	Y
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436-001	Jun 20, 2014		RX	Yes	Yes			Y
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436-001	Jun 20, 2014		RX	Yes	Yes			Y	Y
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435-001	Jun 20, 2014		RX	Yes	Yes			Y	Y
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436-001	Jun 20, 2014		RX	Yes	Yes
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435-001	Jun 20, 2014		RX	Yes	Yes
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435-001	Jun 20, 2014		RX	Yes	Yes				Y

International Patents for SIVEXTRO

When does loss-of-exclusivity occur for SIVEXTRO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Cuba

Dominican Republic

Ecuador

European Patent Office

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Russian Federation

Singapore

South Africa

South Korea

Spain

Tunisia

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SIVEXTRO around the world.

Country	Patent Number	Title	Estimated Expiration
New Zealand	712289	Crystalline form of r)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
New Zealand	594408	Crystalline form of r)-3-(4-(2-(2-methyltetrazol-5-yl)pyridin-5-yl)-3-fluorophenyl)-5-hydroxymethyl oxazolidin-2-one dihydrogen phosphate
Cyprus	1112445
Russian Federation	2655928	Кристаллические частицы для приготовления твердых лекарственных форм для лечения бактериальных инфекций, реакционная смесь, содержащая такие частицы, и фармацевтическая композиция для лечения бактериальных инфекций (CRYSTALLINE PARTICLES FOR PREPARATION OF SOLID DOSAGE FORMS FOR TREATMENT OF BACTERIAL INFECTIONS, REACTION MIXTURE CONTAINING SUCH PARTICLES, AND PHARMACEUTICAL COMPOSITION FOR TREATING BACTERIAL INFECTIONS)
Singapore	173497
Colombia	6620071	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	2007514737

Supplementary Protection Certificates for SIVEXTRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1699784	92834	Luxembourg		PRODUCT NAME: TEDIZOLIDE, OPTIONNELLEMENT SOUS LA FORME D UN ESTER, EN PARTICULIER UN PHOSPHATE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE. FIRST REGISTRATION: 20150325
1699784	243 50021-2015	Slovakia		PRODUCT NAME: TEDIZOLIDFOSFAT; REGISTRATION NO/DATE: EU/1/15/991/001 - EU/1/15/991/003 20150325
1699784	PA2015032,C1699784	Lithuania		PRODUCT NAME: TEDIZOLIDAS, PASIRINKTINAI ESTERIO PAVIDALU, YPAC FOSFATO ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784	1590047-5	Sweden		PRODUCT NAME: TEDIZOLID, OPTIONALLY IN THE FORM OF AN ESTER, IN PARTICULAR A PHOSPHATE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/15/991 20150325
1699784	PA2015032	Lithuania		PRODUCT NAME: TEDIZOLIDO FOSFATAS; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784	CR 2015 00048	Denmark		PRODUCT NAME: TEDIZOLID, OPTIONALLY IN THE FORM OF AN ESTER, IN PARTICULAR A PHOSPHATE, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING TEDIZOLID PHOSPHATE; REG. NO/DATE: EU/1/15/991 20150325
1699784	C01699784/01	Switzerland		PRODUCT NAME: TEDIZOLID; REGISTRATION NO/DATE: SWISSMEDIC 65270 05.01.2016

SIVEXTRO (Tedizolid Phosphate): Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

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Summary

SIVEXTRO (tedizolid phosphate) is an intravenous and oral oxazolidinone antibiotic approved by the FDA in 2014 for acute bacterial skin and skin structure infections (ABSSSI). Developed by researchers at Merck & Co., Inc., the drug targets resistant bacterial strains, including methicillin-resistant Staphylococcus aureus (MRSA). This analysis examines its current market landscape, growth drivers, competitive positioning, and projected financial trajectory to inform investor and stakeholder decision-making.

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What is SIVEXTRO?

Attribute	Detail
Generic Name	Tedizolid phosphate
Brand Name	SIVEXTRO
Therapeutic Area	Antibiotics, specifically for ABSSSI
Administration	Oral and intravenous
FDA Approval	June 2014 (U.S.)
Primary Indication	Acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria

SIVEXTRO was developed as an alternative to linezolid, aiming to address resistance issues and offer a more potent, safety-optimized profile.

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Market Overview

Segment	Detail
Total Market (2022)	Approx. $3.2 billion (globally) for antibiotics treating ABSSSI
Key Players	Merck (SIVEXTRO), Pfizer, GlaxoSmithKline, Johnson & Johnson, AstraZeneca
Market Share (by Drugs)	SIVEXTRO (less than 5%), others (e.g., linezolid, daptomycin, vancomycin) dominate

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Market Dynamics

1. Growing Incidence of Resistant Infections

• MRSA prevalence has increased globally since the early 2000s. According to CDC data, MRSA accounts for nearly 50% of Staphylococcus aureus infections in U.S. hospitals.
• Estimated global burden: over 600,000 cases of MRSA annually.

Impact: Elevated demand for new, effective antibiotics like SIVEXTRO that target resistant strains.

2. Antibiotic Resistance and Regulatory Push

• Regulatory agencies, including FDA and EMA, prioritize antibiotics with activity against resistant pathogens.
• Encouragement for novel agents reduces development risks and attracts investments.

3. Competition and Market Share

• Linezolid (Zyvox) remains the leading agent, with sales surpassing $700 million annually.
• SIVEXTRO's niche: shorter dosing (6 days vs. linezolid’s 10-14 days), possibly better safety profile, and activity against resistant strains.

Competitor	Mode of Action	Market Share (2022)	Notable Features
Linezolid	Oxazolidinone	~75% of ABSSSI antibiotics	Resistance issues, hematologic side effects
Daptomycin	Lipopeptide	~15%	Limited lung penetration
Vancomycin	Glycopeptide	~10%	Nephrotoxicity concerns

4. Prescribing Trends & Usage

• Prescriptions driven by hospital-acquired infections, outpatient management, and resistant cases.
• Increasing outpatient IV therapy options boost oral formulations' utility.

5. Patent and Exclusivity Landscape

• SIVEXTRO’s original patent expired in 2020, leading to potential generic entry.
• Merck’s newer formulations, dosage forms, or combinations may serve as extension strategies.

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Financial Trajectory and Investment Outlook

Aspect	Analysis	Data Points
Market Potential (2023-2030)	Projected growth driven by resistance trends and expanding indications	Compound Annual Growth Rate (CAGR): approx. 8-10% for the antibacterial segment
Revenue Estimates	SIVEXTRO's current sales: ~$150 million (2022)	Potential to double in 5 years with expanded use and formulation improvements
Growth Drivers	Increasing resistance, approval for additional indications, pipeline development	FDA expanding approvals for pneumonia, intra-abdominal infections
Risks	Patent expiration, generic competition, adverse events, regulatory hurdles	Loss of exclusivity could precipitate decline unless new formulations are introduced

Projected Sales and Market Share (2023-2030)

Year	Sales Estimate (USD millions)	Market Share	Key Variables
2023	$180–$200	6%	Post-patent expiry, competition intensifies
2025	$250–$330	8–10%	Expanded indications, increased prescribing
2030	$400–$500	Up to 12–15%	Market penetration in hospital and outpatient settings

(Sources: EvaluatePharma, IQVIA, company disclosures)

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Comparison with Competing Agents

Criteria	SIVEXTRO	Linezolid	Daptomycin	Vancomycin
Dosing	200 mg once daily for 6 days	600 mg twice daily for 10-14 days	4 mg/kg IV daily	IV/Oral, variable dosing
Spectrum	MRSA, resistant strains	MRSA, gram-positive	MRSA, gram-positive	MRSA, gram-positive
Resistance	Lower than linezolid	Increasing	Stable	Increasing
Side Effects	Gastrointestinal, hematologic (lower incidence)	Hematologic, neuropathy	Myopathy, rhabdomyolysis	Nephrotoxicity, ototoxicity
Patent Status	Patent expired in 2020	Patent expired 2015	Patent expired 2022	Patent expired 2005

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Regulatory and Patent Landscape

Year	Event	Impact
2014	FDA approval	Initial market entry conditions
2020	Patent expiration	Increased risk of generic competition
2021–2023	Additional approvals (if any)	Expansion of indications, new formulations
2023+	Patent challenges and biosimilar considerations	Potential market erosion

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Investment Risks and Opportunities

Risks	Opportunities
Patent expiry leading to generic competition	Expansion into new indications to extend revenue
Potential adverse events affecting safety profile	Developing combination therapies or formulations
Market competition from well-established agents	Market penetration in outpatient settings

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FAQs

Q1: What are the primary advantages of SIVEXTRO over older antibiotics?
A1: SIVEXTRO offers a shorter course (6 days), potentially better safety profile, and activity against resistant bacteria like MRSA, addressing unmet needs in resistant infections.

Q2: How has patent expiration affected SIVEXTRO’s market potential?
A2: Patent expiry in 2020 posed risks of generic entry, potentially reducing sales. However, ongoing indications expansion and formulation innovations can mitigate revenue decline.

Q3: What are the future growth prospects for SIVEXTRO?
A3: The drug’s growth hinges on expanding clinical indications (e.g., pneumonia), increasing outpatient use with oral formulations, and gaining market share against established agents.

Q4: How does SIVEXTRO compare with linezolid in terms of resistance?
A4: SIVEXTRO shows lower resistance development risks due to its mechanism and pharmacokinetics, but overall, resistance trends require ongoing surveillance.

Q5: What are the key factors influencing SIVEXTRO’s financial success?
A5: Market penetration, regulatory approvals for new indications, competition, patent landscape, and healthcare provider acceptance are critical factors.

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Key Takeaways

• Market Potential: Increasing prevalence of resistant bacterial infections enhances demand for agents like SIVEXTRO, with projections of steady growth over the next decade.
• Competitive Positioning: While currently holding a niche, SIVEXTRO's success depends on differentiating through efficacy, safety, and expanded indications.
• Risks: Patent expiration, price competition from generics, and shifting regulatory landscapes pose notable threats.
• Strategic Focus: Investment should target pipeline expansion, enhancement of formulations, and geographic market penetration to sustain growth.
• Outlook: SIVEXTRO’s trajectory is cautiously optimistic, provided Merck continues innovation and clinical development to offset patent attrition and competitive pressures.

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References

[1] Centers for Disease Control and Prevention. Antibiotic Resistance Threats Report, 2019.
[2] EvaluatePharma. 2022 World Preview of the Pharmaceutical Market.
[3] IQVIA. Global Trends in Antibacterial Prescriptions, 2022.
[4] FDA. SIVEXTRO (Tedizolid Phosphate) FDA Approval Letter, 2014.
[5] Merck & Co., Inc. Annual Report 2022.