SIVEXTRO Drug Patent Profile

« Back to Dashboard

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

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

The generic ingredient in SIVEXTRO is tedizolid phosphate. There is one drug master file entry for this compound. 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

US Patents:	7
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	5
Patent Applications:	153
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:

10,065,947

NDA:

205436

Dosage:

POWDER;INTRAVENOUS

Constraining patent/regulatory exclusivity:

10,065,947

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
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Phase 2
Los Angeles Biomedical Research Institute	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 10,065,947.

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

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
African Regional IP Organization (ARIPO)	2987
Australia	2010210627
Brazil	PI1008829

Supplementary Protection Certificates for SIVEXTRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1699784	C300759	Netherlands		PRODUCT NAME: TEDIZOLID, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/15/991 20150323
1699784	PA2015032	Lithuania		PRODUCT NAME: TEDIZOLIDO FOSFATAS; REGISTRATION NO/DATE: EU/1/15/991 20150323
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

SIVEXTRO Market Dynamics, Financial Trajectory, Patents, and Generic Entry Risk

Last updated: October 30, 2026

SIVEXTRO, the brand name for tedizolid phosphate, is a niche anti-infective marketed by Merck for acute bacterial skin and skin-structure infections. Its commercial profile is constrained by the size of the approved market, competition from generic linezolid and long-acting antibiotics, hospital antibiotic stewardship, and the absence of separately reported revenue in Merck’s financial statements. The product retains commercial value through once-daily dosing, a six-day treatment course, and oral and intravenous formulations, but it is not a major contributor to Merck’s pharmaceutical revenue.

What is SIVEXTRO and how is it used?

SIVEXTRO is an oxazolidinone antibiotic containing tedizolid phosphate. The FDA approved it on June 20, 2014, for the treatment of acute bacterial skin and skin-structure infections caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus.[1]

Attribute	SIVEXTRO profile
Active ingredient	Tedizolid phosphate
Brand owner and marketer	Merck & Co., Inc., through Merck Sharp & Dohme
FDA approval	June 20, 2014
FDA indication	Acute bacterial skin and skin-structure infections
Dosage	200 mg once daily
Treatment duration	Six days
Formulations	Oral tablets and intravenous injection
Drug class	Oxazolidinone antibacterial
Main comparator	Linezolid, including generic linezolid
Regulatory pathway	New drug application, NDA 205435

SIVEXTRO was designed to preserve the oxazolidinone mechanism of linezolid while reducing dosing frequency and treatment duration. The six-day regimen is shorter than the usual 10- to 14-day linezolid course for comparable infections. The label does not establish broad clinical superiority over linezolid across all relevant endpoints.[1]

How has the SIVEXTRO market developed since launch?

SIVEXTRO entered the market during a period of intense competition in hospital and infectious-disease medicine. Its launch was supported by a differentiated dosing profile, but uptake was limited by several factors:

1. Generic linezolid was already available or approaching broad generic availability.
2. Vancomycin remained a widely used inpatient standard.
3. Long-acting agents such as dalbavancin and oritavancin offered less frequent administration.
4. Hospitals imposed antibiotic stewardship restrictions on newer agents.
5. Acute bacterial skin infections are a meaningful clinical category but not a large chronic-use market.

SIVEXTRO’s principal commercial advantage is operational rather than transformational. Once-daily oral and intravenous administration can simplify treatment, particularly when a patient transitions from inpatient intravenous therapy to outpatient oral therapy. The six-day course can reduce pill burden and treatment duration.

The principal commercial disadvantage is that generic linezolid provides a lower-cost alternative with extensive clinical familiarity. SIVEXTRO also competes with agents that offer different value propositions, including long-acting intravenous therapies that can eliminate daily dosing.

SIVEXTRO competitive landscape

Product	Company or market position	Dosing and positioning	Competitive effect
SIVEXTRO	Merck	Once daily for six days; oral and IV	Short-course oxazolidinone option
Generic linezolid	Multiple generic manufacturers	Usually twice daily; generally longer course	Major price competitor
Zyvox	Pfizer, originator brand	Linezolid, oral and IV	Brand reference product, limited price advantage
Vancomycin	Multiple manufacturers	IV, monitoring often required	Hospital standard and low-cost option
Dalbavancin	AbbVie, formerly Melinta	Long-acting IV therapy	Reduces administration frequency
Oritavancin	Melinta	Single-dose IV option	Competes in outpatient treatment
Delafloxacin	Melinta	Oral and IV fluoroquinolone	Alternative for selected ABSSSI cases
Omadacycline	Paratek	Oral and IV tetracycline-class agent	Alternative for resistant infections

The product’s economic value depends heavily on local formularies, infectious-disease protocols, hospital acquisition costs, and reimbursement. SIVEXTRO is most defensible where clinicians value short treatment duration, oral bioavailability, and avoidance of linezolid-associated monitoring or tolerability concerns.

What is the financial trajectory of SIVEXTRO?

Merck does not report SIVEXTRO as a standalone revenue line in its public annual reports. The company reports major products individually but places smaller products within broader pharmaceutical or other-product categories.[2-5] As a result, there is no reliable public series for annual SIVEXTRO net sales, gross margin, or operating profit.

The available financial interpretation is therefore directional:

Period	Commercial development	Financial implication
2014	FDA approval and launch	Initial launch investment and hospital formulary buildout
2015-2017	Early commercialization amid generic-linezolid competition	Limited contribution relative to Merck’s major products
2018-2020	Mature niche positioning	Revenue likely stabilized within Merck’s smaller-product portfolio
2021 onward	Continued availability without separate public reporting	Product remained commercially relevant but immaterial to consolidated Merck revenue

SIVEXTRO was acquired as part of Merck’s 2015 purchase of Cubist Pharmaceuticals. The transaction was valued at approximately $9.5 billion, including assumed debt, and gave Merck a portfolio of anti-infective products, including Cubicin, Zerbaxa, and SIVEXTRO.[6] The acquisition thesis relied more heavily on Cubicin and the broader hospital anti-infective portfolio than on SIVEXTRO alone.

SIVEXTRO’s revenue trajectory has likely been shaped by portfolio-level cost controls rather than standalone expansion. The lack of individual disclosure indicates that sales have not met Merck’s threshold for separate reporting. This does not establish that the product is unprofitable. A mature branded hospital antibiotic can remain commercially attractive if manufacturing costs are controlled and promotional requirements are limited.

When does SIVEXTRO lose exclusivity?

SIVEXTRO’s key regulatory exclusivity expired in 2019, five years after FDA approval. New chemical entity exclusivity generally prevents submission of an abbreviated new drug application for five years, subject to the statutory patent-challenge exception.[1][7]

The commercial protection period is longer than the FDA exclusivity period because patent rights may continue after regulatory exclusivity ends.

Protection type	Relevant date or period
FDA approval	June 20, 2014
Five-year NCE exclusivity	Generally through June 20, 2019
Earliest routine ANDA submission date	Generally June 20, 2018, if accompanied by a Paragraph IV certification
Core U.S. patent commonly associated with tedizolid	U.S. Patent No. 8,716,294
Reported expiration for core patent	December 24, 2028, subject to applicable patent-term adjustments or extensions
Generic launch risk	Highest after expiration or upon a successful Paragraph IV challenge

The patent term shown in commercial patent databases and Orange Book records should be distinguished from FDA regulatory exclusivity. Patent expiry does not automatically produce generic entry if other listed patents remain enforceable, if a court blocks launch, or if a settlement delays entry.

What patents protect SIVEXTRO?

The principal patent estate protects tedizolid-related compounds and pharmaceutical uses. Public patent records identify U.S. Patent No. 8,716,294 as a core patent associated with tedizolid phosphate and the SIVEXTRO product.[8]

The relevant protection categories are:

Composition and active-ingredient patents

Composition patents provide the strongest protection because they cover the active pharmaceutical ingredient or closely related chemical compounds. A valid composition patent can block commercial sale of a generic product regardless of whether the generic manufacturer changes excipients or packaging.

Formulation patents

SIVEXTRO is available as oral tablets and an intravenous formulation. Formulation claims may cover dosage forms, salts, solid-state properties, excipients, or methods for preparing the dosage form. Formulation patents are generally narrower than composition patents and may be easier to design around.

Method-of-use patents

The approved use is treatment of acute bacterial skin and skin-structure infections. Method-of-use patents can create targeted protection if they cover a specific patient population, dosage regimen, or treatment protocol. They generally do not prevent an ANDA applicant from marketing a product for unpatented uses if the applicant properly labels the product.

The commercial strength of the estate is therefore highest at the active-ingredient level and lower for narrow formulation or method-of-use claims. Tedizolid’s six-day regimen may support regimen-specific claims, but the scope and enforceability of any such claims depend on the live Orange Book listing and the patent language.

What is the Orange Book status of SIVEXTRO?

SIVEXTRO is listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the Orange Book, under NDA 205435.[7] The Orange Book is the controlling public source for listed patents, pediatric exclusivity, therapeutic-equivalence information, and patent certification context.

The relevant Hatch-Waxman pathways are:

• Paragraph I: no patent information is listed.
• Paragraph II: the listed patent has expired.
• Paragraph III: the applicant accepts delayed approval until the patent expires.
• Paragraph IV: the applicant asserts that the patent is invalid, unenforceable, or will not be infringed.

A Paragraph IV certification can trigger patent litigation by the NDA holder or patent owner. If suit is filed within the statutory period, FDA approval may be stayed for up to 30 months, subject to court decisions and statutory exceptions.[9]

No major publicly reported Paragraph IV litigation has established an earlier SIVEXTRO generic launch. The absence of a prominent public challenge does not remove future risk, particularly as the core patent approaches expiration.

Which companies could challenge SIVEXTRO?

Potential generic challengers include large ANDA manufacturers with hospital-antibiotic portfolios and smaller companies specializing in difficult-to-manufacture oral and injectable products. The most likely entrants would seek approval for tedizolid phosphate tablets, with injectable competition requiring additional manufacturing, sterility, and supply-chain capabilities.

Potential entrants would evaluate:

• The scope and remaining term of the core composition patent.
• Orange Book-listed formulation or use patents.
• Availability and cost of tedizolid phosphate active ingredient.
• Bioequivalence requirements for oral tablets.
• Injectable manufacturing and sterile-filling requirements.
• Expected generic price erosion.
• Hospital formulary adoption and market size.

Because SIVEXTRO is a small market relative to high-volume oral drugs, a generic launch may attract fewer competitors. That could moderate the speed of price erosion. The opposite risk is that one approved generic could materially reduce branded volume because hospital purchasers are highly price-sensitive.

What generic launch scenarios exist for SIVEXTRO?

Scenario 1: Launch after core patent expiry

A generic manufacturer launches after the principal patent expires, subject to any remaining listed patents. This is the lowest litigation-risk scenario and the most predictable pathway.

Scenario 2: Paragraph IV challenge

An ANDA applicant challenges the core patent before expiry. Merck or the relevant patent owner may file suit, potentially producing a 30-month stay. The result could be an earlier launch, a delayed launch, or a settlement with a licensed entry date.

Scenario 3: Authorized generic or licensed entry

Merck could authorize another manufacturer to sell a generic or near-generic version. No major publicly disclosed SIVEXTRO authorized-generic transaction is established in the cited sources.

Scenario 4: Formulation-specific entry

A challenger could enter with tablets while avoiding injectable competition, or vice versa, depending on patent scope and manufacturing economics. This would create partial rather than full generic pressure.

How strong is the SIVEXTRO patent estate?

SIVEXTRO has moderate remaining protection value but limited long-term commercial leverage.

Factor	Assessment
Core active-ingredient protection	Stronger than formulation or use claims
Regulatory exclusivity	Expired
Time to reported core-patent expiry	Limited but material
Generic substitution risk	High after core patent expiry
Biosimilar risk	None, because SIVEXTRO is a small-molecule drug
Formulation complexity	Moderate for tablets; higher for sterile injectable
Market attractiveness to generics	Moderate to low because of niche volume
Pricing durability	Vulnerable to hospital purchasing pressure
Litigation value	Dependent on remaining listed patents and claim scope

The main commercial barrier is not biosimilar regulation. Tedizolid is a chemically synthesized small molecule and would be challenged through the ANDA pathway, not the biosimilar pathway under the Public Health Service Act.

What manufacturing and intellectual-property barriers affect SIVEXTRO?

The oral tablet is likely easier to reproduce than the intravenous product. Generic manufacturers must establish pharmaceutical equivalence, bioequivalence, quality controls, and reliable supply of the active ingredient. The injectable formulation adds sterile manufacturing, container-closure integrity, stability, and injectable-product quality requirements.

Manufacturing barriers may slow entry but are unlikely to prevent competition permanently if the market supports adequate returns. Intellectual-property barriers are more consequential before the core patent expires. After that date, remaining formulation and use patents may affect specific presentations or labels but are less likely to preserve broad branded exclusivity.

What is the commercial outlook for SIVEXTRO?

SIVEXTRO is best viewed as a mature, defensible niche antibiotic rather than a growth product. Its near-term value rests on continued formulary access, physician familiarity, supply reliability, and the clinical convenience of a six-day oral or intravenous course.

The main risks are:

• Generic linezolid price pressure.
• Hospital stewardship restrictions.
• Substitution by long-acting antibiotics.
• Limited expansion of the approved indication.
• Generic entry after core patent expiry.
• Low standalone revenue relative to Merck’s reporting threshold.

The main support factors are:

• Once-daily administration.
• Oral and intravenous availability.
• Short treatment duration.
• Established use in resistant Gram-positive infections.
• Potentially limited generic participation because of market size and sterile manufacturing requirements.

Key Takeaways

• SIVEXTRO is Merck’s tedizolid phosphate antibiotic for acute bacterial skin and skin-structure infections.
• FDA approval occurred on June 20, 2014, and five-year NCE exclusivity ended in 2019.
• Merck does not separately disclose SIVEXTRO revenue, preventing a verified standalone sales series.
• The product is a mature niche asset, not a material contributor to Merck’s consolidated revenue.
• U.S. Patent No. 8,716,294 is a core patent publicly associated with tedizolid, with reported expiration on December 24, 2028.
• The product faces substantial competition from generic linezolid, vancomycin, dalbavancin, oritavancin, delafloxacin, and omadacycline.
• SIVEXTRO has no biosimilar risk because it is a small-molecule drug. Its relevant future challenge pathway is an ANDA Paragraph IV filing.
• Generic entry risk rises sharply after core patent expiry, although sterile injectable manufacturing may limit the number of entrants.
• The product’s commercial value depends on formulary positioning and convenience rather than broad market expansion.

FAQs

Is SIVEXTRO still patent protected?

The core U.S. patent publicly associated with tedizolid is reported to expire in December 2028. The live Orange Book listing controls the current patent position, including any additional formulation or use patents.

Does SIVEXTRO have orphan-drug exclusivity?

SIVEXTRO was approved for acute bacterial skin and skin-structure infections, not a designated rare disease indication. Its principal regulatory protection was five-year new chemical entity exclusivity rather than orphan-drug exclusivity.

Is tedizolid a generic version of linezolid?

No. Tedizolid and linezolid are different active ingredients within the oxazolidinone class. Generic linezolid competes with SIVEXTRO but is not a generic version of tedizolid.

Can a generic manufacturer launch SIVEXTRO before 2028?

A manufacturer could seek an earlier launch through a Paragraph IV patent challenge, a successful noninfringement or invalidity position, a license, or a settlement. Without such an outcome, broad generic entry would generally be expected after enforceable patent protection expires.

Why has Merck not disclosed SIVEXTRO sales separately?

Merck’s public reporting separately identifies major products but groups smaller products into broader categories. SIVEXTRO sales are therefore not sufficiently material, or are not separately reported, for investors to verify a standalone annual revenue trend from company filings.

References

1. U.S. Food and Drug Administration. (2014). SIVEXTRO (tedizolid phosphate) prescribing information.
2. Merck & Co., Inc. (2014). 2014 annual report.
3. Merck & Co., Inc. (2015). 2015 annual report.
4. Merck & Co., Inc. (2020). 2020 annual report.
5. Merck & Co., Inc. (2023). 2023 annual report.
6. Merck & Co., Inc. (2015). Merck completes acquisition of Cubist Pharmaceuticals.
7. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations.
8. U.S. Patent and Trademark Office. (2014). U.S. Patent No. 8,716,294, oxazolidinone derivatives.
9. U.S. Food and Drug Administration. (2024). Abbreviated new drug application approvals and patent certifications.

DrugChatter Q&A for SIVEXTRO

Is sivextro available as an oral tablet?
Is sivextro effective against mrsa?