SIVEXTRO Drug Patent Profile

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.

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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	62
Clinical Trials:	5
Patent Applications:	149
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
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 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
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
African Regional IP Organization (ARIPO)	2987
Australia	2010210627
Brazil	PI1008829
Canada	2751392
Chile	2011001855
China	102439006

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
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	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	300759	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME

Last updated: June 1, 2026

SIVEXTRO (tedizolid phosphate) Market Dynamics and Financial Trajectory: Pricing, Uptake, Exclusivity, and Generic/Biosimilar Threats

Executive summary: SIVEXTRO (tedizolid phosphate) is a niche, label-limited oxazolidinone antibiotic with U.S. revenue that peaked early after launch and has since faced slower life-cycle growth due to higher acquisition friction versus linezolid and strong formulary incumbency. The product’s market trajectory is driven by (1) inpatient/outpatient stewardship protocols favoring narrow-spectrum options when appropriate, (2) hospital formulary and substitution dynamics within Gram-positive and MRSA coverage, (3) limited competitive headroom once linezolid is established across institutions, and (4) the IP and exclusivity schedule shaping generic entry timing in the U.S. The commercial ceiling is further constrained by the short-course regimen and restricted indications (skin infections; later expansion to CABP), which reduces switching incentives compared with chronic therapies.

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What is SIVEXTRO (tedizolid phosphate) and how does it compete in the antibiotic market?

SIVEXTRO is a prescription antibiotic in the oxazolidinone class. In the U.S., it is positioned against Gram-positive pathogens, including MRSA, with a clinical value proposition around short duration dosing compared with older comparators. Its commercialization hinges on stewardship, formulary placement, and empiric treatment patterns in targeted settings.

Where does SIVEXTRO sit in hospital antibiotic decision-making?

Competition is predominantly against:

• Linezolid (oral and IV, older, widely adopted)
• Vancomycin (common MRSA backbone in inpatient protocols)
• Other MRSA-active agents used depending on allergy, renal function, and local resistance patterns

Hospital buyers typically weigh:

• Drug acquisition cost versus total course costs
• Administration workflow (IV-to-PO transitions, dosing frequency)
• Clinical pathway fit (empiric MRSA coverage policies)
• Stewardship restrictions and prior-authorization criteria

Why do antibiotics like SIVEXTRO often show “shape” revenue curves?

Antibiotic uptake commonly follows a pattern:

• Rapid post-launch penetration in early adopters
• Slower growth once hospital formularies stabilize
• Revenue volatility tied to seasonal infections, payer contracting, and stewardship policy changes

For SIVEXTRO, the short-course regimen limits the number of treated cases per patient over time, which caps unit demand growth even if per-course adoption improves.

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What are the key drivers of SIVEXTRO sales growth or decline?

1) Formulary placement and contracting

SIVEXTRO’s sales are sensitive to:

• National and regional group purchasing organization (GPO) contracts
• Hospital-specific pharmacy and therapeutics committee decisions
• National payer tiering and outpatient pharmacy reimbursement

In hospital antibiotics, formulary access is a major determinant of volume. Once linezolid is embedded, switching requires clear economic or workflow advantage.

2) Indication scope and use-case volume

SIVEXTRO’s addressable market is constrained by its labeled uses relative to broader antibacterial classes. Expansions (if any within the life cycle) can help, but the total number of eligible patients remains smaller than for broad-spectrum antibiotics.

3) Stewardship and MRSA epidemiology

Changes in:

• MRSA prevalence
• guideline adherence
• de-escalation practices
• culture-confirmed therapy rates affect drug selection intensity

When MRSA rates rise, MRSA-active agents gain relative share. When de-escalation is prompt, narrow agents can displace empiric options.

4) Buyer behavior under short-course regimens

Short-course therapies can win share in “time-to-discharge” and care pathway optimization, but they still face:

• benchmark competition from long-established products with known acquisition and ordering habits
• switching costs across inventory, order sets, and prescriber familiarity

5) Safety and tolerability positioning versus linezolid

SIVEXTRO is often evaluated through the lens of oxazolidinone class differences. Uptake depends on whether clinicians perceive a meaningful advantage in tolerability, especially for patients with risk factors where linezolid monitoring is a concern.

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When does SIVEXTRO lose exclusivity in the U.S., and what generic entry risks exist?

Executive answer: The generic entry risk is governed by the FDA exclusivity landscape (Orange Book patents and any data exclusivity) and the earliest filing/approval pathway that can legally launch while patents remain listed. Without the specific Orange Book patent list and FDA exclusivity codes tied to SIVEXTRO for the exact NDA product/strength, a precise date cannot be stated here.

How to interpret exclusivity timing for antibiotic brands

For antibiotics, commercial impact usually appears:

• at the first lawful generic launch date
• at subsequent waves when multiple ANDAs enter, pressuring net price

The market commonly reacts after:

• local contract renegotiations
• pharmacy switching protocols
• payer medical policy updates

Paragraph IV challenges: what matters for timing

For timing certainty, the decisive facts are:

• whether any ANDA has a Paragraph IV certification versus listed patents
• the patent(s) asserted in the first litigation
• settlement terms that can delay effective launch (including authorized generic provisions)

Without the Orange Book list of patent numbers and the litigation record for those patents, this cannot be grounded in hard dates.

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What is the Orange Book status of SIVEXTRO (tedizolid phosphate)?

Executive answer: A definitive Orange Book status summary (listed patents by use/formulation/method, expiration dates, and any exclusivity-patent interplay) cannot be produced without the Orange Book listing data for the specific SIVEXTRO NDA, strengths, dosage forms, and patent identifiers.

Why Orange Book data is central to market modeling

Orange Book status determines:

• likelihood of timely generic approvals
• whether the brand remains protected for specific formulations or methods of use
• how quickly pricing pressure emerges after first ANDA entry

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How strong is the patent estate for SIVEXTRO and which filings protect formulations or methods?

Executive answer: A defensible assessment of patent strength requires a mapped set of:

• Orange Book-listed patents
• non-listed secondary patents that can still be asserted
• relevant district court case law tied to those patents
• geographic coverage of filings (primarily U.S., but also WO/PCT families for overseas launch timing)

Without a patent list and litigation docket citations, patent strength cannot be quantified in a way that supports licensing or investment decisions.

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What patent litigation affects SIVEXTRO generic launch in the U.S.?

Executive answer: Litigation-driven delays are material for antibiotics because settlements can shift the practical launch timeline by years. A hard, decision-grade litigation summary requires:

• asserted patent numbers
• filing dates for ANDAs and Paragraph IV notices
• case numbers and settlement/consent-decree terms

Those records are not provided here, so a factual litigation narrative cannot be constructed.

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How do SIVEXTRO’s commercial economics compare with linezolid and vancomycin?

Pricing and net revenue pressure

In antibiotics, net price depends on:

• hospital contract concessions and rebates
• shift from branded to contracted equivalent therapy
• the breadth of formulary coverage

Linezolid has scale advantage, which often compresses branded premium. SIVEXTRO’s net price premium can persist only if it earns a formulary “preferred” slot or if clinical pathway incentives outweigh cost.

Unit economics

For an acute-care short-course therapy:

• volume is case-driven and protocol-driven
• net revenue is sensitive to hospital penetration rather than patient lifetime value
• adoption tends to plateau quickly absent guideline changes

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What is the SIVEXTRO financial trajectory: revenue drivers, decline phases, and inflection points?

Executive answer: A quantified revenue trajectory (e.g., annual U.S. sales, net price trends, and market share) cannot be stated here without the relevant financial datasets or drug-specific sales figures. A directional model can still be stated from market structure:

Typical life-cycle dynamics for SIVEXTRO-like antibiotics

• Early growth phase: penetration across early-adopter hospitals; payers establish coverage; prescriber adoption builds.
• Maturing phase: competition tightens against linezolid and generics; formulary access stabilizes.
• Pressure phase: when generics enter competitors or when formulary committees prefer established low-cost pathways.
• Late life-cycle: use becomes more protocol-specific, shrinking addressable volume.

For SIVEXTRO, the constrained indication footprint and reliance on MRSA-relevant decision points tend to produce a faster plateau than in broad-spectrum or chronic categories.

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Which companies market SIVEXTRO, and how does the competitive landscape shape share?

SIVEXTRO’s competitive landscape is not only drug-to-drug. It is also:

• contracting and pharmacy benefit leverage
• antimicrobial stewardship and guideline committees
• institutional stock management and IV-to-PO protocols

Competitive set: likely substitutes

• Generic or branded linezolid variants, where formularies allow substitution
• Vancomycin where local protocols use it as default MRSA coverage
• Other MRSA-active agents used by institutional pathways

Brand share depends on whether clinicians view SIVEXTRO as “preferred” for specific patient subsets or if it is a fallback after first-line options.

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What generic entry scenarios could affect SIVEXTRO pricing and volume?

Executive answer: The entry scenarios that matter commercially are:

1. A first ANDA launch on the earliest legally permitted date for the listed product(s)
2. Follow-on entrants that intensify price competition
3. Authorized generic or settlement-linked entry that accelerates net price erosion

A precise scenario analysis cannot be produced without Orange Book patent granularity and FDA approval timelines.

Market impact mechanics

When an antibiotic brand loses exclusivity:

• wholesaler distribution shifts with contract renewals
• hospital pharmacy systems update order sets
• prescribers face fewer formulary barriers to substitute

The result is typically:

• steep initial net price declines
• partial volume maintenance only when clinical preference is strong or when substitution restrictions apply

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How does the outpatient versus inpatient channel split drive SIVEXTRO outcomes?

SIVEXTRO’s regimen design affects channel mix:

• inpatient use is tied to empiric pathways and stewardship controls
• outpatient use depends on payer coverage, antibiotic stewardship in community settings, and the availability of oral alternatives

Channel differences matter because contracting and substitution rules differ by:

• institutional purchasing models (inpatient)
• pharmacy benefit design (outpatient)

Without dispensing data and claims-derived mix, the channel contribution cannot be quantified.

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Key Takeaways

• SIVEXTRO’s market performance is shaped primarily by hospital formulary decisions, antibiotic stewardship protocols, and substitution pressure from linezolid and other MRSA-active agents.
• The revenue curve for short-course acute-care antibiotics typically peaks early and then plateaus as formularies stabilize and cost benchmarks tighten.
• Generic entry risk is governed by Orange Book patents and exclusivity events; a decision-grade timeline requires the exact SIVEXTRO Orange Book listing and the Paragraph IV/litigation record tied to it.
• Commercial downside risk usually manifests first through net price erosion and then through volume substitution following lawful generic launches or authorized generic strategies.

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FAQs

1) What portion of SIVEXTRO use is driven by MRSA-focused empiric protocols versus culture-confirmed therapy?
2) How do stewardship prior-authorization criteria affect SIVEXTRO hospital uptake?
3) What hospital contracting levers most influence SIVEXTRO net pricing versus linezolid?
4) What settlement terms in antibiotic Paragraph IV cases typically shift practical launch timing?
5) How do oral step-down pathways change the economics of short-course antibiotics like SIVEXTRO?

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References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (U.S.).
2. FDA drug label and prescribing information for SIVEXTRO (tedizolid phosphate).

DrugChatter Q&A for SIVEXTRO

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