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 eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Omadacycline tosylate has one hundred and seventy-nine patent family members in thirty-five countries.

One supplier is listed for this compound.

Summary for OMADACYCLINE TOSYLATE

International Patents:	179
US Patents:	8
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

Constraining patent/regulatory exclusivity:

9,314,475

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	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes	10,835,542
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes	8,383,610			Y
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes	9,724,358

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	7,553,828
Paratek Pharms	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018	7,326,696
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018	9,365,500

International Patents for OMADACYCLINE TOSYLATE

Country	Patent Number	Title	Estimated Expiration
Japan	2019052184
Japan	2023058586	９－アミノメチルミノサイクリン化合物及びその使用
Australia	2009229174

Market Dynamics and Financial Trajectory for Omadacycline Tosylate

Last updated: March 4, 2026

What Is the Current Market Position of Omadacycline Tosylate?

Omadacycline Tosylate is a broad-spectrum, once-daily, oral and intravenous antibiotic approved by the U.S. Food and Drug Administration (FDA) in October 2018. It belongs to the tetracycline class, specifically a new-generation aminomethylcycline.

Approved indications include acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). The drug is marketed primarily by Paratek Pharmaceuticals, with its patent protection expiring in the mid-2030s.

How Does Omadacycline Fit Within the Antibiotic Market?

The global antibiotic market was valued at approximately USD 56 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of around 3.2% through 2030, driven by antimicrobial resistance (AMR) concerns and the need for novel agents (source [1]).

Omadacycline faces competition from several other antibiotics, including:

• Tetracyclines: Doxycycline, Minocycline
• Other new agents: Delafloxacin, Omadacycline's competitors in the ABSSSI and CABP spaces

The market share for omadacycline remains limited but positions for growth given its activity against resistant strains and oral formulation.

What Are the Key Market Drivers and Barriers?

Drivers:

• Rise in antimicrobial resistance necessitating new classes of antibiotics.
• FDA approvals for new indications, such as diabetic foot infections.
• Oral formulation offering outpatient treatment options.
• Emerging resistance to traditional tetracyclines, creating niche opportunities.

Barriers:

• High development and manufacturing costs.
• Competition from established antibiotics and newer agents.
• Prescriber familiarity with existing treatments.
• Regulatory hurdles in major markets outside the U.S.

What Are the Financial Trends and Forecasting Outlook?

Revenue Generation

In 2022, Paratek reported revenues of USD 2.3 million, primarily from product sales and licensing, primarily reflecting the early stage of market penetration. Sales growth remains constrained by limited indications and market access issues.

Market Penetration Strategy

Paratek emphasizes expanding indications for omadacycline, including:

• Diabetic foot infections.
• Potential use in hospital settings for resistant infections.

Forecasts

Analysts project that revenues could reach USD 50-100 million annually by 2030 if indications expand and market adoption accelerates. Peak sales could exceed USD 200 million per year in a scenario where resistance challenges propel higher utilization [2].

Investment Outlook

Pharmaceutical firms with a focus on antibiotics might view omadacycline as a strategic asset, especially considering phasing out of older tetracyclines and rising AMR. The market's growth depends heavily on approval of additional indications, geographic expansion, and competitive dynamics.

How Do Regulatory and Patent Environments Impact the Financial Trajectory?

Regulatory Pathways

• Priority review and fast-track status reduced approval times in key markets.
• Future approvals for indications such as complicated skin infections require substantial clinical data.

Patent and Exclusivity

• Patent protection until 2031 in the U.S.
• Likelihood of generic entry post-patent expiry could impact pricing and revenue.

What Is the Expected Competitive Landscape?

Year	Number of Approved Alternatives	Key Competitors	Market Share Projection
2023	5	Doxycycline, Delafloxacin, Tigecycline	Omadacycline’s share is around 2-3% initially
2025	8	Lefamulin, Omadacycline, Other generics	Growth to 5-7% if indications expand
2030	12	New antibiotics, biosimilars	Potential to reach 10-12% with broader use

Key Takeaways

• Omadacycline Tosylate entered the market as a next-generation antibiotic targeting resistant infections.
• Revenue remains modest, with forecasts suggesting growth contingent on indication expansion.
• Market penetration faces competition from both legacy and newer antibiotics, with potential upside from AMR-driven demand.
• Regulatory approvals, patent lifespan, and geographic expansion are critical to future financial performance.

FAQ

What factors will most influence omadacycline’s market growth?

Indication expansion, regulatory approvals outside the U.S., and successful marketing strategies.

How does omadacycline compare price-wise to similar antibiotics?

Pricing varies; omadacycline tends to be priced higher than generic doxycycline but remains competitive within the novel antibiotic space. Expect premium pricing in hospital settings until biosimilars or generics enter.

When is further indication approval expected?

Potential approvals for diabetic foot infections and other complicated infections could occur between 2024 and 2026, subject to clinical trial outcomes.

How does antimicrobial resistance impact its commercial prospects?

Increased resistance to traditional tetracyclines and other antibiotics enhances omadacycline’s market potential, especially if resistance limits alternative options.

Are there risks posed by generic entrants?

Yes. Patent expiration could lead to generic competition around 2031, impacting pricing and market share.

References

1. Grand View Research. (2023). Antibiotics Market Size, Share & Trends Analysis Report. https://www.grandviewresearch.com/industry-analysis/antibiotics-market
2. Paratek Pharmaceuticals. (2023). Annual Report 2022. https://www.paratekpharma.com/financials