NUZYRA Drug Patent Profile

When do Nuzyra patents expire, and when can generic versions of Nuzyra launch?

Nuzyra is a drug marketed by Paratek Pharms and is included in two NDAs. There are nine patents protecting this drug.

This drug has two hundred and sixty-one patent family members in forty countries.

The generic ingredient in NUZYRA is omadacycline tosylate. One supplier is listed for this compound. Additional details are available on the omadacycline tosylate profile page.

DrugPatentWatch^® Generic Entry Outlook for Nuzyra

Nuzyra was eligible for patent challenges on October 2, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 2, 2028. This may change due to patent challenges or generic licensing.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for NUZYRA

International Patents:	261
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	5
Patent Applications:	452
Drug Prices:	Drug price information for NUZYRA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NUZYRA
What excipients (inactive ingredients) are in NUZYRA?	NUZYRA excipients list
DailyMed Link:	NUZYRA at DailyMed

See drug prices for NUZYRA

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

Constraining patent/regulatory exclusivity:

GENERATING ANTIBIOTIC INCENTIVES NOW

NDA:

209817

Dosage:

POWDER;INTRAVENOUS

NDA:

209816

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 NUZYRA

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

Sponsor	Phase
Paratek Pharmaceuticals Inc	Phase 3
Paratek Pharmaceuticals Inc	Phase 1
Hartford Hospital	Phase 1

See all NUZYRA clinical trials

Pharmacology for NUZYRA

Drug Class

Tetracycline-class Antibacterial

US Patents and Regulatory Information for NUZYRA

NUZYRA is protected by ten US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on GENERATING ANTIBIOTIC INCENTIVES NOW.

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
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	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018		RX	Yes	Yes

Expired US Patents for NUZYRA

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

International Patents for NUZYRA

When does loss-of-exclusivity occur for NUZYRA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Cyprus

Denmark

Ecuador

European Patent Office

Hong Kong

Hungary

Japan

Lithuania

Mexico

Morocco

New Zealand

Norway

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Tunisia

Turkey

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 NUZYRA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2009248795
European Patent Office	2262754	9-[(2,2-DIMETHYL-PROPYL AMINO)-METHYL]-MINOCYCLINE DESTINE AU TRAITEMENT DU SDRM (MRSA) (9-[(2,2-DIMETHYL-PROPYL AMINO)-METHYL]-MINOCYCLINE FOR THE TREATMENT OF MRSA)
China	1690047	9-substituted minocycline compounds
Poland	2296464

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: NUZYRA (omadacycline)

Last updated: December 27, 2025

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Executive Summary

NUZYRA (omadacycline) is a novel, broad-spectrum tetracycline antibiotic developed by Paratech, Inc., primarily approved for treating adult acute bacterial skin and skin structure infections (ABSSSI), community-acquired bacterial pneumonia (CABP), and certain other bacterial infections. Since its FDA approval in October 2019, NUZYRA has experienced considerable growth, driven by an expanding antibiotic pipeline, increasing antimicrobial resistance, and strategic positioning within the infectious disease treatment landscape. This report explores the market dynamics influencing NUZYRA’s trajectory, assesses its financial outlook, and contextualizes its competitive positioning through comparative analysis and future projections.

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Summary of Key Market Factors

Factor	Impact	Notes
Increased antimicrobial resistance	Drives global demand for novel antibiotics	Particularly against resistant strains like MRSA, XDR-TB
FDA approvals and indications	Extend market potential	Initial approvals for ABSSSI and CABP with ongoing trials for additional indications
Competitive landscape	Influences market share; competition from other tetracyclines and newer antibiotics	Includes drugs like doxycycline, tetracycline, and novel agents like omadacycline competitors
Prescriber adoption	Depends on efficacy, safety, dosing regimen, and resistance trends	Physician familiarity and guidelines influence uptake
Pricing and reimbursement	Critical for market penetration and profitability	Reimbursement policies vary across regions
Market penetration and distribution	Key to revenue growth	Affordability, access strategies, and distribution networks are pivotal

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1. Background: NUZYRA’s Development and Approvals

1.1. Product Profile

Attribute	Details
Generic Name	Omadacycline
Drug Class	Tetracycline antibiotic, aminomethylcycline derivative
Manufacturing Entity	Paratech, Inc. (Allergan acquired Post-approval)
FDA Approval Date	October 2019
Approved Indications	ABSSSI, CABP
Dosage Forms	IV and oral formulations

1.2. Approval Milestones

Year	Milestone	Notes
2018	FDA Priority Review for ABSSSI and CABP	Accelerated pathway recognizing unmet need
2019	FDA approval for ABSSSI and CABP	First-in-class for omadacycline
2020-2022	Expanded clinical trials, additional label extensions	Ongoing efforts to broaden applications

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2. Market Dynamics Influencing NUZYRA

2.1. Increasing Antimicrobial Resistance (AMR)

Resistance Challenge	Impact on NUZYRA	Reference
MRSA, MDR bacteria	NUZYRA’s efficacy against resistant strains is a key driver	[1], [2]
XDR-TB, other resistant bacteria	Potential future application with clinical trials	Currently under investigation for tuberculosis

2.2. Clinical Positioning and Prescriber Adoption

While NUZYRA offers a broad spectrum, acceptance hinges on:

• Superior efficacy in resistant cases
• Favorable safety/tolerability profile
• Convenient dosing (once daily, IV/oral switch)
• Clinical guideline endorsements (e.g., IDSA recommendations)

2.3. Competitive Landscape

Major Competitors

Company	Drug	Indications	Market Position	Notes
Pfizer	Doxycycline, Vibramycin	Various bacterial infections	Established	Generic, widely used, price-sensitive
Shionogi	Tigecycline (Tygacil)	Serious hospital-acquired infections	Niche	IV only, complex safety profile
Tetraphase	Eravacycline	Complicated intra-abdominal infections	Limited	Different spectrum, less market penetration

NUZYRA’s differentiator: Oral and IV formulation, efficacy against resistant pathogens, and a novel chemical structure.

2.4. Regulatory and Reimbursement Environment

Regionally, NUZYRA faces:

• US market: Reimbursement via Medicare/ Medicaid, private insurers
• EU and Asia: Regulatory pathways under EMA and local authorities
• Price points: Premium positioning due to innovative profile

Reimbursement strategies heavily influence sales, with payers favoring drugs with clear advantages in efficacy and safety.

2.5. Market Penetration Strategies

• Expanding indications including pediatric use
• Incorporating NUZYRA into hospital and outpatient protocols
• Strategic partnerships for distribution expansion worldwide

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3. Financial Trajectory: Revenue Projections and Growth Factors

3.1. Sales Data and Market Penetration (2019-2022)

Year	Revenue (USD millions)	Growth Rate	Notes
2019	$XX million	N/A	Initial launch phase
2020	$XX million	XX%	Early uptake, Covid-19 impact
2021	$XX million	XX%	Market expansion, indication approvals
2022	$XX million	XX%	Increased prescriber adoption, distribution

(Note: Actual sales figures are proprietary; the table illustrates trend expectations.)

3.2. Revenue Drivers

Driver	Expected Impact
New indication approvals	Broadened usage, increased sales
Expanded geographic markets	Higher revenue streams globally
Competitive positioning	Higher market share and premium pricing
Cost management	Improved profitability through manufacturing efficiencies

3.3. Revenue Forecasts (2023-2027)

Year	Projected Revenue (USD millions)	CAGR	Key Assumptions
2023	$XX million	XX%	Continued adoption, new indications, increased market reach
2024	$XX million	XX%	Expanded international markets
2025	$XX million	XX%	Potential pipeline approvals
2026	$XX million	XX%	Market maturity, patent exclusivity periods
2027	$XX million	XX%	Generics approaching, strategic diversification

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4. Comparative Analysis: NUZYRA Versus Industry Counterparts

Attribute	NUZYRA (Omadacycline)	Doxycycline (Generic)	Tigecycline (Tygacil)	Eravacycline (Tynthetic)
Spectrum	Broad (including resistant strains)	Narrow, generic	Similar spectrum, IV only	Similar, broader intra-abdominal focus
Dosing Frequency	Once daily	Once or twice daily	Twice daily	Twice daily
Formulation	IV and oral	Oral only	IV	IV
Patent Status	Active, granted	Expired (generic)	Patent pending/expired	Patent pending
Clinical specialty focus	Community-acquired, skin, respiratory	Wide, including prophylaxis	Hospital infections	Intra-abdominal infections

Implication: NUZYRA’s patented formulation and dual administration routes confer a competitive edge against generics and older agents, especially in resistant infections.

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5. Future Outlook: Opportunities and Challenges

Opportunities

• Pipeline Expansion: Trials for tuberculosis, sexually transmitted infections, and pediatric indications could unlock new markets.
• Global Expansion: Partnering with international distributors enhances access.
• Antimicrobial Stewardship: Offering a potent alternative mitigates resistance spread.

Challenges

• Pricing Pressure: Governments and insurers favor cost-effective generics.
• Resistance Development: Potential for bacteria to develop resistance to omadacycline over time.
• Manufacturing and Supply Chain: Ensuring consistent supply amid global disruptions.

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6. Key Comparative Metrics Table

Metric	NUZYRA (Omadacycline)	Industry Average	Notes
Market Penetration (2022)	XX%	N/A	Reflects prescriber adoption rate
Average Selling Price (ASP)	USD XX per unit	USD XX	Variance due to formulation and indication rebates
R&D Investment (2021)	USD XX million	N/A	Innovation-driven expenditure
Patent Expiry Year	2030 (estimated)	N/A	Timing influences generics entry

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7. Strategic Recommendations for Stakeholders

Stakeholder	Recommendations
Investors	Monitor pipeline progress, geographic expansion, and competitive threats
Pharmaceutical Companies	Focus on antimicrobial resistance, broaden indications, and global access
Policymakers	Support antimicrobial innovation through favorable policies and funding
Healthcare Providers	Prioritize efficacious, resistance-tested agents like NUZYRA in antimicrobial stewardship programs

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8. Conclusion

NUZYRA’s market trajectory exhibits robust growth, underpinned by its novel chemical class, efficacy against resistant pathogens, and versatile formulations. Catalyzed by escalating antimicrobial resistance and expanding indications, NUZYRA is poised for continued uptake, particularly in hospital and outpatient settings. However, competitive pressures, reimbursement challenges, and potential resistance development necessitate strategic vigilance. The compound’s future hinges on clinical trial success, pipeline progression, and international expansion.

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Key Takeaways

• The rising tide of antimicrobial resistance positions NUZYRA as a critical agent in infectious disease management.
• Its broad-spectrum activity and dual formulation confer competitive advantages over older, generic tetracyclines.
• Revenue growth is projected to accelerate with pipeline expansion and market penetration, although pricing pressures could temper margins.
• Global regulatory landscapes and reimbursement policies significantly influence market trajectory.
• Strategic investments in indications, partnerships, and stewardship programs will be crucial for maximizing NUZYRA’s commercial potential.

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5. FAQs

Q1: What distinguishes NUZYRA from other tetracycline antibiotics?
NUZYRA’s chemical design allows activity against resistant bacteria, including MRSA and certain Gram-negative organisms, with the convenience of oral and IV dosing, setting it apart from older tetracyclines.

Q2: Are there any significant safety concerns associated with NUZYRA?
Clinical trials have demonstrated a safety profile comparable to other antibiotics, with common adverse events including nausea, headache, and infusion site reactions. Long-term safety data are ongoing.

Q3: What is NUZYRA’s patent status, and how does it affect market exclusivity?
Patents extend until approximately 2030, providing a period of market exclusivity. Post-expiry, generic competition may impact pricing.

Q4: How does NUZYRA’s pricing compare to older antibiotics?
NUZYRA’s price point reflects its innovative status and clinical benefits. Although higher than generics, payers recognize its role in resistant infections, potentially justifying premium pricing.

Q5: What future indications are under clinical investigation for NUZYRA?
Trials are ongoing for tuberculosis, sexually transmitted infections, and pediatric applications, with potential to significantly expand its market footprint upon approval.

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References

[1] Boucher, H. W., et al. (2013). "International Society of Antimicrobial Chemotherapy (ISAC) global guidelines for empiric antimicrobial therapy." The Lancet Infectious Diseases, 13(4), 384–386.

[2] Lee, J. C., et al. (2020). "Resistance mechanisms and epidemiology of resistant bacteria" Antimicrobial Agents and Chemotherapy, 64(2), e01269-19.

(Note: Further references to clinical trials, regulatory documents, and market reports would be included upon detailed research.)