OMADACYCLINE TOSYLATE - Generic Drug Details

What are the generic drug sources for omadacycline tosylate and what is the scope of patent protection?

Omadacycline tosylate is the generic ingredient in one branded drug marketed by Paratek Pharms and is included in two NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Omadacycline tosylate has two hundred and sixty-one patent family members in forty countries.

One supplier is listed for this compound.

Summary for OMADACYCLINE TOSYLATE

International Patents:	261
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	12
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OMADACYCLINE TOSYLATE
DailyMed Link:	OMADACYCLINE TOSYLATE at DailyMed

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

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.

Pharmacology for OMADACYCLINE TOSYLATE

Drug Class

Tetracycline-class Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for OMADACYCLINE TOSYLATE

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for OMADACYCLINE TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Paratek Pharms	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018		RX	Yes	Yes
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes
Paratek Pharms	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018		RX	Yes	Yes
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes				Y
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes

Expired US Patents for OMADACYCLINE TOSYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018
Paratek Pharms	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018
Paratek Pharms	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018
Paratek Pharms	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018

International Patents for OMADACYCLINE TOSYLATE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1301467	COMPOSES DE MONOCYCLINE 9-SUBSTITUES (9-SUBSTITUTED MINOCYCLINE COMPOUNDS)
Taiwan	202423450
China	100473644
Taiwan	201000433
Ukraine	109627	КОМПОЗИЦІЇ ТЕТРАЦИКЛІНОВИХ СПОЛУК ДЛЯ ОРАЛЬНОГО ВВЕДЕННЯ ТА ІН'ЄКЦІЙ
Denmark	2296464

Market Dynamics and Financial Trajectory for OMADACYCLINE TOSYLATE

Last updated: July 27, 2025

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Introduction

Omadacycline tosylate, a novel aminomethylcycline antibiotic, has emerged as a significant candidate within the global antimicrobial market. Approved by the U.S. Food and Drug Administration (FDA) in 2018 for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), omadacycline's unique pharmacological profile positions it as a promising solution against resistant bacterial strains. This article analyzes the prevailing market dynamics and forecasts the financial trajectory of omadacycline tosylate, providing critical insights for stakeholders, investors, and healthcare strategists.

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Market Landscape

Antimicrobial Market Overview

The antimicrobial market, valued at approximately USD 50 billion in 2022, is driven by increasing antibiotic resistance, a rising prevalence of infectious diseases, and the slow pace of novel antibiotic development. According to the CDC, antibiotic-resistant bacteria cause over 2.8 million infections annually in the U.S., with more than 35,000 deaths—a clear impetus for innovative antimicrobial agents such as omadacycline.

Positioning of Omadacycline in the Antibiotic Market

Omadacycline belongs to the tetracycline class but advances the field through its enhanced activity against resistant strains, including MRSA, VRE, and atypical pathogens. Its broad-spectrum activity, oral and intravenous formulations, and consistent efficacy in both respiratory and skin infections position it favorably within the competitive landscape.

Major competitors include drugs like doxycycline, tigecycline, levofloxacin, and newer agents such as delafloxacin. However, omadacycline’s clinical advantages in resistant infections and patient compliance could establish it as a preferred therapy in specific segments.

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Market Drivers

1. Rising Antibiotic Resistance

Healthcare providers face mounting challenges from multidrug-resistant organisms (MDROs). Omadacycline's efficacy against resistant pathogens enhances its appeal as a treatment option where conventional antibiotics falter [1].

2. Unmet Clinical Needs

The advent of omadacycline addresses gaps in treating resistant pneumonia and skin infections, often caused by pathogens unresponsive to standard therapies, fostering demand.

3. Regulatory Approvals and Geographic Expansion

Following FDA approval, regulatory bodies in Europe and Asia have expressed interest in approving omadacycline, indicating potential for international market penetration. Expansion into these markets hinges on additional clinical approvals and post-marketing data.

4. Rising Healthcare Expenditure

Increased healthcare spending, especially in developed markets, coupled with rising prevalence of respiratory and skin infections, benefits omadacycline’s market viability.

5. Formulation Flexibility

Omadacycline's dual oral and IV formulations improve treatment compliance and outpatient management, critical for reducing hospital stays, thus appealing to payers and providers.

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Market Challenges

1. Pricing and Reimbursement

Being a novel agent, omadacycline’s pricing remains high relative to generic antibiotics. Securing reimbursement and convincing payers of its cost-benefit ratio pose hurdles, especially in cost-sensitive markets.

2. Competition from Existing and Emerging Antibiotics

Established antibiotics with generic status and new entrants aiming at resistant infections threaten omadacycline’s market share. Its long-term success depends on clinical differentiation and stewardship.

3. Limited Indications and Off-label Risks

Currently approved for specific indications, expansion into broader infectious diseases necessitates additional clinical trials, delaying revenue growth.

4. Antibiotic Stewardship Policies

Global efforts to curb antibiotic misuse may restrict omadacycline’s deployability, especially in outpatient settings, impacting sales volume.

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Financial Trajectory and Forecast

Revenue Projections

Based on current prescriptions, market penetration, and pending approvals, analysts project a compound annual growth rate (CAGR) of roughly 15-20% for omadacycline sales from 2023 through 2030 [2].

Initial revenue streams are constrained, primarily driven by high prices and limited indication approval. However, as approved indications expand and awareness spreads, revenues are expected to accelerate.

Key factors influencing revenue include:

• Commercial acceptance in the U.S. and Europe: Early adoption stems from infectious disease specialists and hospital formularies, with outpatient clinics following.

• Expansion into new indications: Pending FDA and international approvals for other infectious diseases could serve as catalysts.

• Market penetration strategies: Strategic partnerships and aggressive marketing will be vital for capturing market share, particularly against entrenched generics.

Profitability Outlook

While initial sales may be modest due to high R&D and marketing expenses, profitability trends depend on volume growth, pricing strategies, and reimbursement negotiations. Cost efficiencies from manufacturing and potential biosimilar competition will influence margins.

Regulatory and Clinical Development Impact

Success in ongoing clinical trials for indications like complicated urinary tract infections (cUTI) or gonorrhea could diversify revenue streams. Conversely, regulatory setbacks or adverse clinical data could hinder growth prospects.

Global Market Opportunities

Emerging markets offer substantial growth opportunities owing to high infectious disease burdens and increasing antibiotic resistance, albeit with pricing sensitivities and regulatory uncertainties.

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Key Market Trends and Strategic Outlook

• Increased Focus on Antibiotic Stewardship: To balance effective usage with resistance mitigation, stewardship programs will influence prescribing behaviors.
• Personalized Therapy and Diagnostics: Advances in rapid diagnostics may enhance omadacycline’s targeted application, expanding usage.
• Integration with Hospital Formularies: Favorable inclusion in hospital protocols will boost short-term sales.
• Partnerships and Licensing Agreements: Collaborations with regional players can accelerate market penetration and financial returns.

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Conclusion

Omadacycline tosylate stands at a pivotal juncture. Its unique efficacy against resistant pathogens, flexible formulation, and approved indications position it as a promising asset within the global antibiotic market. Nonetheless, its financial trajectory hinges on overcoming pricing challenges, expanding indications, and navigating competitive and regulatory landscapes. The product's long-term success will depend on strategic market expansion, clinical validation, and effective stakeholder engagement.

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Key Takeaways

• Growing Resistance and Unmet Needs: Omadacycline’s efficacy against multidrug-resistant organisms grants it strategic significance in combating the global antibiotic resistance crisis.
• Market Penetration Potential: The drug’s dual formulation and broad-spectrum activity support adoption in inpatient and outpatient settings.
• Revenue Growth Prospects: Projected CAGR of 15-20% through 2030, contingent upon indication expansion and regulatory approvals.
• Pricing and Reimbursement: High drug costs and reimbursement policy nuances could temper initial sales but are offset by clinical advantages.
• Strategic Positioning: Successful integration into treatment guidelines, international expansion, and partnerships will be critical for financial outperforming.

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FAQs

1. What are the primary indications for omadacycline tosylate?
Approved by the FDA for community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI), omadacycline offers broad-spectrum activity against resistant pathogens, filling critical gaps in current antimicrobial therapy.

2. How does omadacycline compare to other antibiotics in terms of resistance?
Omadacycline demonstrates superior activity against several resistant bacteria, including MRSA and VRE, owing to its structural modifications that confer stability against common tetracycline resistance mechanisms.

3. What are the main barriers to omadacycline’s market growth?
Pricing, reimbursement hurdles, limited initial indications, competition from generics, and stewardship policies restrict rapid uptake, requiring strategic mitigation.

4. Which markets hold the greatest potential for omadacycline expansion?
The U.S., Europe, and Asia-Pacific represent high-growth regions, with emerging markets offering additional opportunities amid rising infectious disease burdens.

5. What factors could significantly influence omadacycline’s financial success in the coming decade?
Successful indication expansion, broad reimbursement coverage, strategic global partnerships, and evolving resistance patterns are key determinants of its long-term profitability.

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References

[1] CDC Antibiotic Resistance Threats Report. (2022). Centers for Disease Control and Prevention.

[2] MarketWatch. (2023). Antimicrobial Market Outlook and Forecasts.