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. Two suppliers are 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 December 31, 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
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	5
Patent Applications:	172
Drug Prices:	Drug price information for SIVEXTRO
What excipients (inactive ingredients) are in SIVEXTRO?	SIVEXTRO excipients list
DailyMed Link:	SIVEXTRO at DailyMed

See drug prices for SIVEXTRO

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

Constraining patent/regulatory exclusivity:

8,426,389

NDA:

205436

Dosage:

POWDER;INTRAVENOUS

Constraining patent/regulatory exclusivity:

8,426,389

NDA:

205435

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 SIVEXTRO

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

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 2
Los Angeles Biomedical Research Institute	Phase 2
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Phase 2

See all SIVEXTRO clinical trials

Pharmacology for SIVEXTRO

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

US Patents and Regulatory Information for SIVEXTRO

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

This potential generic entry date is based on patent 8,426,389.

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	8,426,389		Y	Y
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436-001	Jun 20, 2014		RX	Yes	Yes	10,065,947		Y
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436-001	Jun 20, 2014		RX	Yes	Yes	9,624,250		Y	Y
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435-001	Jun 20, 2014		RX	Yes	Yes	9,624,250		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

EU/EMA Drug Approvals for SIVEXTRO

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 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
Russian Federation	2010149618	НОВЫЕ ПРОИЗВОДНЫЕ ОКСАЗОЛИДИНОНА, СПОСОБ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЕ
Peru	20120585	FORMA CRISTALINA DEL FOSFATO DE DIHIDROGENO R)-3-(4-(2-(2-METILTETRAZOL-5-IL) PIRIDIN-5-IL)-3-FLUOROFENSIL)-5-HIDROXIMETIL OXAZOLIDIN-2-ONA
Japan	5584705
Ukraine	114068	КРИСТАЛІЧНІ ЧАСТИНКИ (R)-3-(4-(2-(2-МЕТИЛТЕТРАЗОЛ-5-ІЛ)ПІРИДИН-5-ІЛ)-3-ФТОРФЕНІЛ)-5-ГІДРОКСИМЕТИЛОКСАЗОЛІДИН-2-ОНДИВОДЕНЬФОСФАТУ
Singapore	173497
New Zealand	575842	NOVEL OXAZOLIDINONE DERIVATIVES

Supplementary Protection Certificates for SIVEXTRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1699784	CA 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	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	C300759	Netherlands		PRODUCT NAME: TEDIZOLID, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/15/991 20150323
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	52/2015	Austria		PRODUCT NAME: TEDIZOLID, WAHLWEISE IN DER FORM EINES ESTERS, INSBESONDERE EINES PHOSPHATS, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784	675	Finland

Market Dynamics and Financial Trajectory for SIVEXTRO

Last updated: July 27, 2025

---

Introduction

SIVEXTRO (tedizolid phosphate) is an oral and intravenous antibiotic developed by Melinta Therapeutics. Approved by the U.S. Food and Drug Administration (FDA) in 2019 for the treatment of acute bacterial skin and skin structure infections (ABSSSI), SIVEXTRO represents a significant advancement in the management of resistant Gram-positive pathogens, notably methicillin-resistant Staphylococcus aureus (MRSA). As the landscape of bacterial resistance intensifies, understanding the market dynamics and financial outlook for SIVEXTRO is crucial for stakeholders, including investors, healthcare providers, and pharmaceutical strategists.

---

Market Landscape and Key Drivers

1. Growing Antibiotic Resistance and Unmet Medical Need

The surge in antibiotic-resistant infections, particularly MRSA, underpins the demand for novel antibiotics like SIVEXTRO. According to the CDC, MRSA causes over 80,000 invasive infections annually in the U.S., with a significant portion being skin infections suitable for SIVEXTRO treatment [1]. The limited pipeline of new anti-MRSA agents further underscores the importance of SIVEXTRO's role, especially as traditional therapies face diminishing efficacy.

2. Competitive Positioning and Differentiation

SIVEXTRO's mechanism as a once-daily oxazolidinone offers advantages over existing agents such as linezolid, including a potentially reduced side-effect profile and improved dosing convenience. Its approval for both oral and IV administration enables flexible treatment settings—from inpatient to outpatient care—further broadening its user base.

3. Regulatory and Reimbursement Environment

While initial approvals have been secure, ongoing negotiations with payers influence market penetration. Favorable formulary positioning and reimbursement schemes are critical to driving adoption among clinicians, especially amid increasing cost pressures on healthcare systems.

---

Market Penetration and Adoption Trends

1. Initial Market Reception

Post-launch analysis indicates cautious adoption, primarily driven by prescribers' familiarity with oxazolidinones and the competitive landscape. Melinta's sales figures for SIVEXTRO in the first two years suggest modest uptake, with total revenues approaching approximately $20 million in 2021 [2]. Factors limiting growth include constrained marketing resources and competition from established antibiotics.

2. Expansion Opportunities

Market expansion hinges on several factors:

• Geographic Expansion: While initially FDA-approved in the U.S., potential collaborations or licensing agreements could facilitate regulatory approvals in Europe and other markets.
• New Indications: Clinical trials evaluating SIVEXTRO in pneumonia and other serious infections could diversify revenue streams.
• Outpatient Use Growth: The ability to transition patients to oral SIVEXTRO enhances outpatient therapy, reducing hospital stays and costs.

3. Challenges in Uptake

Barriers include clinician conservatism toward novel antibiotics, concerns over resistance development, and pricing considerations. Additionally, competition from generic agents and newer drugs like delafloxacin or omadacycline presents ongoing threats.

---

Financial Trajectory and Forecasts

1. Revenue Projections

Given current sales figures and market constraints, projections estimate SIVEXTRO's revenue growth at a CAGR of approximately 10-15% over the next five years, contingent on successful expansion and approval of new indications [3]. Market penetration could reach sales exceeding $100 million annually by 2027, assuming increased adoption.

2. Cost and Profitability Factors

Despite modest current revenues, profit margins are affected by development costs and marketing expenses. As production scales and adoption rises, economies of scale could improve margins. Strategic investments in clinical trials and marketing are essential for growth.

3. Impact of Strategic Alliances

Partnerships with larger pharmaceutical entities could accelerate market penetration, enable broader marketing, and facilitate pipeline expansion. Licensing agreements in international markets could contribute significant revenue streams.

---

Regulatory and Competitive Risks

Regulatory shifts, such as new guidelines for antibiotic stewardship or resistance management, can influence market attractiveness. Additionally, the emergence of alternative therapies and generic competitors threaten SIVEXTRO's market share.

Future Outlook and Strategic Implications

The trajectory of SIVEXTRO hinges on effective market positioning, clinical development, and strategic collaborations. The increasing prevalence of resistant infections creates a favorable environment for its growth, provided these strategic elements are optimized.

---

Key Takeaways

• Unmet Need Driving Growth: Rising antibiotic resistance fuels demand for SIVEXTRO—yet, market penetration remains modest.
• Market Expansion is Critical: Geographic and indication expansions are vital to realizing its full revenue potential.
• Competitive Landscape: Established antibiotics and upcoming alternatives underscore the importance of differentiation.
• Financial Outlook: Moderate revenue growth projected over the next five years, with strategic initiatives necessary to accelerate trajectory.
• Risk Factors: Regulatory changes, resistance evolution, and competition pose ongoing challenges.

---

FAQs

1. What differentiates SIVEXTRO from other oxazolidinones like linezolid?
SIVEXTRO offers once-daily dosing, potentially fewer side effects, and the flexibility for oral and IV use, enhancing outpatient treatment options. Its design aims to reduce adverse events associated with prolonged oxazolidinone therapy.

2. What are the primary hurdles to wider adoption of SIVEXTRO?
Barriers include clinician familiarity with existing therapies, cost considerations, and limited marketing resources for widespread awareness.

3. Are there ongoing clinical trials expanding SIVEXTRO’s indications?
Yes, clinical studies are investigating its efficacy in pneumonia and other resistant infections, which could broaden its approved uses and impact sales.

4. How does the competitive landscape influence SIVEXTRO’s market prospects?
Competing agents, such as newer antibiotics and generics, challenge market share. Strategic differentiation and evidence of superior efficacy or safety are essential for growth.

5. What strategic initiatives could enhance SIVEXTRO’s market penetration?
Formulary inclusion, international regulatory approvals, expanded clinical evidence, and strategic partnerships are pivotal in boosting adoption and revenue.

---

References

[1] Centers for Disease Control and Prevention. Antibiotic Resistance threats in the United States, 2019.
[2] Melinta Therapeutics. Financial Reports and Press Releases, 2021.
[3] Industry Forecasting Reports. Market Analysis for Novel Antibiotics, 2022.

---

Note: Financial projections and market estimations are based on current data and trends and are subject to change due to market dynamics.