TEDIZOLID PHOSPHATE - Generic Drug Details

What are the generic sources for tedizolid phosphate and what is the scope of patent protection?

Tedizolid phosphate is the generic ingredient in one branded drug marketed by Cubist Pharms Llc and is included in two NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Tedizolid phosphate has seventy-eight patent family members in thirty-nine countries.

Two suppliers are listed for this compound.

Summary for TEDIZOLID PHOSPHATE

International Patents:	78
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	14
Patent Applications:	181
What excipients (inactive ingredients) are in TEDIZOLID PHOSPHATE?	TEDIZOLID PHOSPHATE excipients list
DailyMed Link:	TEDIZOLID PHOSPHATE at DailyMed

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

Dosage:

POWDER;INTRAVENOUS

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 TEDIZOLID PHOSPHATE

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

Sponsor	Phase
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center	Phase 2
Los Angeles Biomedical Research Institute	Phase 2
University of Southern California	Phase 4

See all TEDIZOLID PHOSPHATE clinical trials

Pharmacology for TEDIZOLID PHOSPHATE

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

Anatomical Therapeutic Chemical (ATC) Classes for TEDIZOLID PHOSPHATE

J01XX	Other antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for TEDIZOLID PHOSPHATE

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

EU/EMA Drug Approvals for TEDIZOLID PHOSPHATE

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/002846 Sivextro 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 TEDIZOLID PHOSPHATE

Country	Patent Number	Title	Estimated Expiration
South Korea	100854211
Ecuador	SP11011285
Russian Federation	2414469	НОВЫЕ ПРОИЗВОДНЫЕ ОКСАЗОЛИДИНОНА (NOVEL OXAZOLIDINONE DERIVATIVES)

Supplementary Protection Certificates for TEDIZOLID PHOSPHATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	C20150036 00229	Estonia		PRODUCT NAME: TEDISOLIIDFOSFAAT;REG NO/DATE: EU/1/15/991 25.03.2015
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

TEDIZOLID PHOSPHATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tedizolid Phosphate

Introduction

Tedizolid phosphate, a novel oxazolidinone antibiotic, has been gaining traction in the pharmaceutical market, particularly for the treatment of acute bacterial skin and skin structure infections (ABSSSIs). Here, we delve into the market dynamics and financial trajectory of this drug.

Market Size and Growth Projections

The global tedizolid phosphate market has shown significant growth and is expected to continue this trend. As of 2023, the market size was valued at approximately USD 1.2 billion and is forecasted to reach around USD 2.7 billion by 2032[1][4].

Clinical Utility and Efficacy

Tedizolid phosphate has demonstrated its efficacy in treating ABSSSIs, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). Clinical trials have shown that a 200-mg once-daily dose over 6 days is noninferior to a 10-day course of linezolid, another oxazolidinone antibiotic[5].

Market Drivers

Several factors are driving the growth of the tedizolid phosphate market:

• Increasing Incidence of ABSSSIs: The rising number of bacterial skin infections, particularly those resistant to traditional antibiotics, has created a significant demand for effective treatments like tedizolid phosphate.
• Antimicrobial Resistance: The growing concern over antimicrobial resistance has led to increased investment in and demand for new antibiotics, including tedizolid phosphate.
• Clinical Benefits: The drug's shorter treatment duration and once-daily dosing regimen enhance patient compliance and reduce the risk of resistance development[5].

Financial Performance of Key Players

Merck, one of the major players in the pharmaceutical industry, has been involved in the development and marketing of tedizolid phosphate under the brand name SIVEXTRO. However, the financial performance of SIVEXTRO has had its challenges:

• Impairment Charges: Merck reported a $612 million impairment charge related to SIVEXTRO in 2019, reflecting lower-than-expected sales and market performance[2].
• Revenue Impact: Despite this, the overall pharmaceutical revenue of Merck has continued to grow, with the company achieving solid growth in other segments like oncology and vaccines.

Competitive Landscape

The antimicrobial drugs market is competitive, with several other antibiotics available for treating ABSSSIs. However, tedizolid phosphate stands out due to its:

• Comparative Added Clinical Benefit: Studies have shown that antimicrobial drugs, including tedizolid phosphate, tend to have higher early market sales if they offer significant clinical benefits compared to existing treatments[3].
• Development and Approval Costs: Tedizolid phosphate, like other antimicrobial drugs, has relatively lower development and approval costs compared to oncology drugs, making it a more viable option for pharmaceutical companies[3].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the pharmaceutical industry:

• Reduced Access to Healthcare: The pandemic led to reduced access to healthcare providers, negatively impacting vaccine sales and other non-COVID-19 related treatments. However, this did not significantly affect the sales of antibiotics like tedizolid phosphate, as bacterial infections continued to be a healthcare concern[2].
• Research and Development: The pandemic accelerated research and development in the pharmaceutical sector, including investments in antimicrobial drugs, which could indirectly benefit the market for tedizolid phosphate.

Market Segmentation

The market for tedizolid phosphate can be segmented based on:

• Geography: The drug is approved and marketed in various regions, with different regulatory environments and market dynamics.
• Indication: Primarily used for ABSSSIs, but potential applications in other bacterial infections are being explored.
• Distribution Channels: Hospital pharmacies, retail pharmacies, and online platforms play crucial roles in the distribution of tedizolid phosphate.

Regulatory Environment

The regulatory approval process for tedizolid phosphate has been a critical factor in its market success:

• FDA Approval: The drug received FDA approval for the treatment of ABSSSIs, which has been a significant milestone in its market trajectory[5].
• Global Approvals: Approvals in other regions have further expanded its market reach.

Future Outlook

The future outlook for tedizolid phosphate is optimistic:

• Growing Demand: The increasing incidence of bacterial infections and the need for effective antibiotics will continue to drive demand.
• Research and Development: Ongoing research may expand the indications for tedizolid phosphate, further boosting its market potential.
• Market Expansion: Entry into new markets and regions will contribute to the growth of the tedizolid phosphate market.

Key Takeaways

• Market Growth: The global tedizolid phosphate market is projected to grow significantly, reaching USD 2.7 billion by 2032.
• Clinical Efficacy: Tedizolid phosphate has demonstrated efficacy in treating ABSSSIs, including MRSA infections.
• Financial Performance: Despite initial impairment charges, the drug's market performance is expected to improve with growing demand and expanded indications.
• Competitive Advantage: The drug's shorter treatment duration and once-daily dosing regimen offer a competitive edge in the antimicrobial market.

FAQs

What is tedizolid phosphate used for?

Tedizolid phosphate is primarily used for the treatment of acute bacterial skin and skin structure infections (ABSSSIs), including those caused by MRSA.

How effective is tedizolid phosphate compared to other antibiotics?

Tedizolid phosphate has been shown to be noninferior to linezolid in clinical trials, with a shorter treatment duration and once-daily dosing regimen, enhancing patient compliance and reducing the risk of resistance development[5].

What are the market drivers for tedizolid phosphate?

The market drivers include the increasing incidence of ABSSSIs, the growing concern over antimicrobial resistance, and the drug's clinical benefits such as shorter treatment duration and once-daily dosing.

How has the COVID-19 pandemic affected the market for tedizolid phosphate?

The pandemic has had a mixed impact, with reduced access to healthcare providers affecting some pharmaceutical sales but not significantly impacting the demand for antibiotics like tedizolid phosphate.

What is the projected market size for tedizolid phosphate by 2032?

The global tedizolid phosphate market is forecasted to reach approximately USD 2.7 billion by 2032[1][4].

Sources

1. Dataintelo: Global Tedizolid Phosphate Market Research Report 2032.
2. Merck: Merck Announces Fourth-Quarter and Full-Year 2020 Financial Results.
3. ASPE: Antimicrobial Drugs Market Returns Analysis.
4. Market Research Intellect: Global Tedizolid Phosphate Market Size, Scope And Forecast Report.
5. PubMed: Tedizolid phosphate for the management of acute bacterial skin and skin structure infections (ABSSSIs).