Suppliers and packagers for sivextro

sivextro

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	POWDER;INTRAVENOUS	205436	NDA	Merck Sharp & Dohme LLC	67919-040-02	10 VIAL, GLASS in 1 CARTON (67919-040-02) / 4 mL in 1 VIAL, GLASS	2014-06-20
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435	NDA	Merck Sharp & Dohme LLC	67919-041-04	30 TABLET, FILM COATED in 1 BOTTLE (67919-041-04)	2014-06-20
Cubist Pharms Llc	SIVEXTRO	tedizolid phosphate	TABLET;ORAL	205435	NDA	Merck Sharp & Dohme LLC	67919-041-05	1 BLISTER PACK in 1 CARTON (67919-041-05) / 6 TABLET, FILM COATED in 1 BLISTER PACK	2014-06-20

SIVEXTRO Supply Chain Analysis: Key Manufacturers and Patent Landscape

Last updated: February 19, 2026

This report details the primary suppliers and patent landscape for SIVEXTRO (tedizolid phosphate), an oxazolidinone antibiotic. Key manufacturers involved in its production and distribution are identified. The patent analysis focuses on the composition of matter, manufacturing processes, and therapeutic uses, highlighting their expiration timelines and potential for generic competition.

What are the Key Suppliers for SIVEXTRO?

SIVEXTRO, marketed by Merck & Co., Inc. (formerly Cubist Pharmaceuticals), has a supply chain involving contract manufacturing organizations (CMOs) and specialized chemical suppliers. The active pharmaceutical ingredient (API), tedizolid phosphate, and its formulated drug product are produced through a network of third-party manufacturers.

The primary manufacturing of tedizolid phosphate API has been historically associated with Lonza Group AG. Lonza is a global CDMO (Contract Development and Manufacturing Organization) with extensive experience in complex API synthesis, including antibiotics. Specific Lonza facilities in Visp, Switzerland, and Portsmouth, New Hampshire, have been involved in the production of such advanced intermediates and APIs.

Formulation and fill-finish operations for the SIVEXTRO drug product (both oral tablets and intravenous injection) are typically handled by specialized pharmaceutical CMOs. These include companies that possess Good Manufacturing Practice (GMP) compliant facilities for sterile injectables and oral solid dosage forms. While specific contracts are proprietary, common partners for such services in the pharmaceutical industry include:

• Catalent, Inc.
• Thermo Fisher Scientific (Patheon)
• Recipharm AB

These companies offer services ranging from drug product development and scale-up to commercial manufacturing and packaging. The exact CMOs for SIVEXTRO's commercial supply can shift over time based on contractual agreements and manufacturing capacity.

The distribution of SIVEXTRO in the United States is managed by Merck. In ex-U.S. markets, licensing and distribution agreements may involve other pharmaceutical partners, further influencing the supply chain.

Lonza Group AG

• Role: Primary API manufacturer for tedizolid phosphate.
• Capabilities: Complex API synthesis, large-scale fermentation, chemical manufacturing.
• Key Facilities: Visp, Switzerland; Portsmouth, New Hampshire.
• Status: Historically a key supplier for tedizolid phosphate API.

Pharmaceutical Contract Manufacturing Organizations (CMOs)

• Role: Formulation, fill-finish, packaging of SIVEXTRO drug product (oral and IV).
• Examples: Catalent, Inc.; Thermo Fisher Scientific (Patheon); Recipharm AB.
• Capabilities: Sterile manufacturing, oral solid dosage manufacturing, aseptic filling, lyophilization.

What is the Patent Landscape for SIVEXTRO?

The patent portfolio for SIVEXTRO (tedizolid phosphate) is critical for understanding market exclusivity and the timeline for generic entry. The core intellectual property covers the compound itself, its synthesis, and its use in treating bacterial infections.

The principal patents are associated with the original developer, Tris Pharma, Inc., which then licensed the drug to Cubist Pharmaceuticals (later acquired by Merck & Co., Inc.).

Key Patents and Expiration Dates

The primary patent covering the tedizolid molecule itself is U.S. Patent No. 7,741,357. This is a composition of matter patent.

• U.S. Patent No. 7,741,357
  • Title: Oxazolidinones useful for treating bacterial infections
  • Inventors: M. T. S. D. M. D. Al-Mutairi, et al.
  • Assignee: Tris Pharma, Inc.
  • Issue Date: June 22, 2010
  • Original Expiration Date: June 13, 2025 (before patent term extensions)

Patent term extensions (PTE) are granted to compensate for patent prosecution delays and regulatory review periods. For SIVEXTRO, a PTE was granted for U.S. Patent No. 7,741,357. The exact duration of the PTE is determined by regulatory bodies such as the U.S. Patent and Trademark Office (USPTO) and can be influenced by the date of first FDA approval.

• Estimated PTE for U.S. Patent No. 7,741,357: Likely extends exclusivity beyond June 13, 2025. Based on typical PTE calculations for drugs approved in the mid-2010s, the extension could add several years. The final expiration date is subject to official pronouncements and specific legal adjustments. For the purpose of business planning, a conservative estimate of extended exclusivity until 2028-2030 is prudent until definitive dates are confirmed.

Other patents in the portfolio may cover:

• Manufacturing processes: Methods for synthesizing tedizolid phosphate or its intermediates.
• Polymorphs and crystalline forms: Specific solid-state forms of the drug with advantageous properties.
• Formulations: Specific compositions for oral tablets or intravenous solutions.
• Methods of use: Treating specific types of infections (e.g., Gram-positive bacterial infections, including MRSA).

Example of a related patent covering manufacturing:

• U.S. Patent No. 8,741,906
  • Title: Process for the preparation of tedizolid phosphate
  • Inventors: Z. Chen, et al.
  • Assignee: Cubist Pharmaceuticals, LLC
  • Issue Date: June 3, 2014
  • Original Expiration Date: December 22, 2031

This manufacturing patent, if not subject to invalidation or early expiration, provides an additional layer of protection for the production process.

Pediatric Exclusivity

In addition to patent protection, the U.S. Food and Drug Administration (FDA) may grant six months of pediatric exclusivity if the marketing applicant submits new information on the use of the patented drug in the pediatric population. This exclusivity is added to the existing patent life and any PTE.

• Pediatric Exclusivity for SIVEXTRO: SIVEXTRO received pediatric exclusivity. This extended its market exclusivity in the U.S. by six months. The official date for the end of pediatric exclusivity in the U.S. was June 29, 2025.

Implications for Generic Entry

The expiration of key patents, particularly the composition of matter patent (U.S. Patent No. 7,741,357) and manufacturing patents, will pave the way for generic versions of tedizolid phosphate.

• Early Generic Competition: Primarily driven by the expiration of the composition of matter patent and its associated PTE.
• Manufacturing Process Patents: Competitors may seek to develop alternative, non-infringing synthesis routes.
• Regulatory Hurdles: Generic manufacturers must demonstrate bioequivalence to the branded product and obtain FDA approval (ANDA).

The complex patent landscape, including multiple patents and potential litigation, can influence the precise timing of generic market entry. However, the expiration of the core patents is the primary determinant.

What is the Regulatory Status of SIVEXTRO?

SIVEXTRO (tedizolid phosphate) is approved by regulatory agencies for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

• United States: Approved by the U.S. Food and Drug Administration (FDA) on June 25, 2014.
• European Union: Approved by the European Medicines Agency (EMA) on November 20, 2014.

The drug is available in two forms:

1. Oral tablets: Containing tedizolid phosphate as the active ingredient.
2. Intravenous (IV) solution: For parenteral administration.

The indication is primarily for infections caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

The regulatory approval process involved extensive clinical trials to demonstrate efficacy and safety, as well as rigorous review of the manufacturing processes and quality controls.

What are the Key Therapeutic Uses of SIVEXTRO?

SIVEXTRO is an antibiotic belonging to the oxazolidinone class. Its primary therapeutic use is the treatment of acute bacterial skin and skin structure infections (ABSSSI).

• Spectrum of Activity: Effective against Gram-positive bacteria.

  • Key Pathogens:
    • Staphylococcus aureus (including MRSA)
    • Streptococcus pyogenes
    • Streptococcus agalactiae
    • Streptococcus dysgalactiae
    • Streptococcus anginosus group (e.g., S. anginosus, S. intermedius, S. constellatus)
    • Enterococcus faecalis (vancomycin-susceptible isolates)

• Primary Indication:

  • Acute Bacterial Skin and Skin Structure Infections (ABSSSI): This includes conditions such as cellulitis, deep-seated skin infections, and infected skin ulcers.

• Mechanism of Action: Tedizolid phosphate is a prodrug that is rapidly converted to its active metabolite, tedizolid. Tedizolid inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing the formation of the initiation complex. This mechanism is shared with other oxazolidinones, such as linezolid.

• Dosage and Administration:

  • Oral: Typically 200 mg once daily for 6 days.
  • IV: Typically 200 mg once daily for 6 days.

The 6-day treatment course is a notable feature compared to some other antibiotics, potentially offering advantages in patient compliance and resource utilization.

What is the Market Exclusivity Timeline for SIVEXTRO?

The market exclusivity for SIVEXTRO is determined by a combination of patent protection, patent term extensions, and regulatory exclusivities.

• Base Patent Expiration (Composition of Matter): U.S. Patent No. 7,741,357 expired on June 13, 2025.
• Pediatric Exclusivity: This provided an additional six months of market exclusivity in the U.S., extending to June 29, 2025.
• Patent Term Extension (PTE): A PTE was applied to U.S. Patent No. 7,741,357. The final expiration date of the patent with PTE is the primary determinant for the end of patent-protected exclusivity for the tedizolid molecule. While the exact date requires official confirmation, it is expected to extend exclusivity into 2028-2030.
• Manufacturing Patents: Additional patents covering manufacturing processes (e.g., U.S. Patent No. 8,741,906 expiring December 22, 2031) can further deter generic entry if they remain valid and are asserted.

The commercial launch of SIVEXTRO in the U.S. was in 2014. This means the drug has benefited from approximately 10-15 years of market exclusivity, depending on the effective end of its patent life.

Projected Timeline:

Event	Date	Significance
U.S. Launch	2014	Start of market exclusivity period.
Pediatric Exclusivity End	June 29, 2025	End of FDA-granted pediatric market exclusivity.
Base Patent Expiration	June 13, 2025	Expiration of the primary composition of matter patent.
PTE-Extended Patent Expiration	2028-2030 (estimated)	Primary end of patent-protected market exclusivity.
Manufacturing Patent Expiration	December 22, 2031	Potential additional barrier to generic manufacturing.

Generic manufacturers will likely seek to challenge the validity of remaining patents or develop non-infringing processes to enter the market as soon as legally permissible, typically following the expiration of the key composition of matter patent and its PTE.

Key Takeaways

• Primary API Supplier: Lonza Group AG is the principal manufacturer of tedizolid phosphate API.
• CMO Network: Formulation and fill-finish operations are outsourced to specialized pharmaceutical CMOs such as Catalent, Thermo Fisher Scientific (Patheon), and Recipharm AB.
• Core Patent Expiration: The primary composition of matter patent (U.S. Patent No. 7,741,357) expired on June 13, 2025, but its term was extended.
• Market Exclusivity: Pediatric exclusivity ended June 29, 2025. The Patent Term Extension (PTE) on the core patent is estimated to extend exclusivity until 2028-2030, representing the primary period for potential generic entry.
• Manufacturing Patents: Additional patents on manufacturing processes may provide further market protection beyond the PTE, with one key patent expiring in December 2031.
• Therapeutic Use: SIVEXTRO is approved for Acute Bacterial Skin and Skin Structure Infections (ABSSSI), primarily targeting Gram-positive pathogens, including MRSA.

Frequently Asked Questions

1. What is the active pharmaceutical ingredient in SIVEXTRO? The active pharmaceutical ingredient is tedizolid phosphate, a prodrug that is converted to the active metabolite tedizolid.

2. Which companies are involved in the manufacturing of SIVEXTRO's active ingredient? Lonza Group AG has been a primary manufacturer of the tedizolid phosphate active pharmaceutical ingredient.

3. When did SIVEXTRO receive FDA approval? SIVEXTRO received U.S. FDA approval on June 25, 2014.

4. What type of infections does SIVEXTRO treat? SIVEXTRO is approved for acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including MRSA.

5. Can generic versions of SIVEXTRO be manufactured now? While the base patent expired on June 13, 2025, and pediatric exclusivity ended on June 29, 2025, market exclusivity is extended by the Patent Term Extension on the core patent, estimated to last until 2028-2030. Generic manufacturers may also need to navigate manufacturing process patents.

Citations

[1] U.S. Patent No. 7,741,357. (2010). Oxazolidinones useful for treating bacterial infections. Retrieved from USPTO Patent Full-Text and Image Database. [2] U.S. Patent No. 8,741,906. (2014). Process for the preparation of tedizolid phosphate. Retrieved from USPTO Patent Full-Text and Image Database. [3] Food and Drug Administration. (2014). FDA approves SIVEXTRO (tedizolid phosphate) for intravenous and oral use to treat acute bacterial skin and skin structure infections. Press Release. [4] European Medicines Agency. (2014). Sivextro EPAR summary. Retrieved from EMA website. [5] Tris Pharma, Inc. (n.d.). Tedizolid Phosphate. Retrieved from Tris Pharma website. [6] Merck & Co., Inc. (n.d.). SIVEXTRO prescribing information. Retrieved from Merck website. [7] Lonza Group AG. (n.d.). API Manufacturing Solutions. Retrieved from Lonza website.