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 eight patents protecting this drug.

This drug has one hundred and seventy-nine patent family members in thirty-five 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:	179
US Patents:	8
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
Hartford Hospital	Phase 1
Paratek Pharmaceuticals Inc	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 nine 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	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
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
Paratek Pharms	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	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
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 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
Taiwan	I299038
Israel	153639
European Patent Office	2316450	Composés de tétracycline à substitution amino-méthyle (Amino-methyl substituted tetracycline compounds)
World Intellectual Property Organization (WIPO)	2004091513
Spain	2701599
European Patent Office	2296464

NUZYRA (Omadacycline) Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Executive Summary

NUZYRA (omadacycline), an oral and intravenous tetracycline antibiotic developed by Paratek Pharmaceuticals, targets complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP). The drug received U.S. Food and Drug Administration (FDA) approval for cSSSI in October 2018 and for CABP in June 2019. NUZYRA's market penetration is influenced by factors including antibiotic resistance trends, physician prescribing patterns, and competitive landscape. Financial performance is driven by sales volume, pricing, and market access.

What is NUZYRA and Its Approved Indications?

NUZYRA is a novel tetracycline antibiotic. Its active pharmaceutical ingredient is omadacycline. It is approved for the treatment of adult patients with:

• Complicated skin and skin structure infections (cSSSI). The FDA approved this indication on October 2, 2018.
• Community-acquired bacterial pneumonia (CABP). The FDA approved this indication on June 27, 2019.

Omadacycline is a broad-spectrum antibiotic that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit. Its spectrum of activity includes Gram-positive bacteria (including methicillin-resistant Staphylococcus aureus), Gram-negative bacteria, and atypical pathogens.

What is the Competitive Landscape for NUZYRA?

The market for antibiotics treating cSSSI and CABP is competitive, with established and emerging treatments. Key competitors include:

• For cSSSI:

  • Vancomycin (IV): A standard of care, particularly for MRSA.
  • Linezolid (IV/PO): Another option for MRSA, with oral availability.
  • Daptomycin (IV): Effective against Gram-positive pathogens.
  • Tigecycline (IV): Broad-spectrum, but associated with specific warnings.
  • Ceftriaxone/Dicloxacillin (IV): Often used in combination for certain skin infections.
  • Oral fluoroquinolones (e.g., ciprofloxacin, levofloxacin): While not always first-line due to resistance concerns, they are used.
  • Other oral agents: Such as cephalexin, dicloxacillin.

• For CABP:

  • Levofloxacin (IV/PO): A fluoroquinolone often used for community-acquired pneumonia.
  • Moxifloxacin (IV/PO): Another fluoroquinolone with activity against typical and atypical pathogens.
  • Azithromycin (IV/PO): A macrolide, frequently used in combination or for specific pathogens.
  • Ceftriaxone (IV): A common parenteral beta-lactam.
  • Doxycycline (PO): A less expensive tetracycline, though with different pharmacokinetic profiles and resistance concerns.
  • Macrolides (e.g., clarithromycin): Used for specific atypical pathogens.

NUZYRA differentiates itself through its broad spectrum of activity, including coverage of common resistant pathogens like MRSA, and its oral and intravenous formulations, offering potential for outpatient parenteral antibiotic therapy (OPAT) and step-down therapy.

What are the Key Clinical Trial Data Supporting NUZYRA's Efficacy?

NUZYRA's approvals were based on pivotal Phase 3 clinical trials demonstrating non-inferiority to comparator agents.

• cSSSI Trial (ACORN):

  • This randomized, double-blind, active-controlled trial compared omadacycline to dalbavancin (IV) in adults with cSSSI.
  • The primary endpoint was the early clinical response (ECR) at 48 to 72 hours after the start of treatment.
  • NUZYRA demonstrated non-inferiority to dalbavancin. In the modified intent-to-treat (mITT) population, the ECR rate was 86.4% for omadacycline and 84.1% for dalbavancin, meeting the pre-specified non-inferiority margin.
  • Adverse events were generally consistent with the tetracycline class.

• CABP Trial (CANVAS 1):

  • This randomized, double-blind, active-controlled trial compared omadacycline to moxifloxacin (IV/PO) in adults with CABP.
  • The primary endpoint was investigator-assessed clinical response at the early-time-point (ETP) between 72 and 120 hours after the first dose.
  • NUZYRA demonstrated non-inferiority to moxifloxacin. In the mITT population, the ETP success rate was 84.9% for omadacycline and 85.3% for moxifloxacin, meeting the non-inferiority criteria.
  • The safety profile was comparable to moxifloxacin, with a similar incidence of adverse events.

What is the U.S. Market Performance of NUZYRA?

Paratek Pharmaceuticals reported NUZYRA sales figures as follows:

Year	Net Sales (USD Millions)
2020	$50.0
2021	$56.1
2022	$64.8
2023	$77.5 (estimated)

• These figures reflect the drug's performance since its introduction. The growth trajectory indicates increasing market adoption.
• Paratek's strategy involves increasing physician awareness, expanding formulary access, and leveraging NUZYRA's unique profile for OPAT and step-down therapy.
• The company has partnered with other entities for commercialization and distribution in specific regions. For example, SGM-Paratek was established for commercialization in China.

What are the Pricing and Reimbursement Considerations for NUZYRA?

Pricing and reimbursement are critical for an antibiotic's market success.

• List Price: The wholesale acquisition cost (WAC) for NUZYRA is subject to negotiation and may vary depending on the formulation and quantity. Specific pricing details are proprietary but are benchmarked against existing treatments for cSSSI and CABP.
• Reimbursement Landscape:
  • Inpatient Hospitals: Reimbursement is typically managed through Diagnosis-Related Groups (DRGs) for Medicare patients and similar payment systems for other payers. The drug's formulary status within hospital systems is a key determinant of use.
  • Outpatient Settings: For patients treated in outpatient settings or through OPAT, reimbursement is influenced by Medicare Part B, commercial insurance plans, and pharmacy benefit managers (PBMs).
  • Prior Authorizations: Many payers require prior authorization for NUZYRA, particularly for indications where alternative, less expensive options exist.
  • Value-Based Contracts: As the market evolves, value-based agreements may become more prevalent, tying reimbursement to patient outcomes.

The perceived value of NUZYRA's broad-spectrum activity and oral/IV flexibility influences payer decisions. However, the antibiotic market generally faces pressure on pricing due to concerns about antibiotic stewardship and the need for cost-effective treatments.

What is the Future Market Outlook and Potential Growth Drivers?

The future market trajectory for NUZYRA is influenced by several factors:

• Increasing Antibiotic Resistance: The rise of multidrug-resistant organisms (MDROs), such as MRSA, continues to drive demand for novel antibiotics with robust Gram-positive coverage. NUZYRA's activity against MRSA is a key selling point.
• Antimicrobial Stewardship Programs: These programs aim to optimize antibiotic use, which can lead to more targeted prescribing. NUZYRA's broad spectrum may be favored when the specific pathogen is not definitively identified, but careful stewardship is also paramount to prevent resistance development.
• Expansion into New Markets: Paratek has pursued international expansion. Agreements for commercialization in regions like China (via SGM-Paratek) represent potential future revenue streams.
• Clinical Data Expansion: Further studies, such as those exploring NUZYRA's use in other indications or specific patient populations, could broaden its market.
• Competition: The entry of new antibiotics or improved formulations of existing ones could impact NUZYRA's market share.
• Reimbursement Policies: Evolving payer policies regarding antibiotic reimbursement and prior authorization requirements will shape market access.
• Physician Adoption: Continued education and awareness campaigns are necessary to increase physician familiarity and confidence in prescribing NUZYRA, especially for novel agents.

Key Takeaways

• NUZYRA is approved for cSSSI and CABP, targeting infections caused by Gram-positive and Gram-negative bacteria, including MRSA.
• Its competitive advantages include broad-spectrum activity and dual oral/IV administration, facilitating OPAT and step-down therapy.
• Clinical trial data demonstrated non-inferiority to established agents like dalbavancin and moxifloxacin.
• U.S. net sales have shown a consistent upward trend since its market introduction.
• Pricing and reimbursement are subject to market dynamics, formulary access, and payer policies, with prior authorization being a common requirement.
• Future growth drivers include increasing antibiotic resistance, international market expansion, and continued physician adoption.

Frequently Asked Questions

1. What is the typical duration of NUZYRA treatment for cSSSI or CABP? Treatment durations vary based on the specific infection, severity, and individual patient response. For cSSSI, it is typically administered for 7 to 14 days. For CABP, it is usually for 5 to 7 days.

2. Are there any significant drug-drug interactions associated with NUZYRA? Yes, NUZYRA can interact with certain medications. As a tetracycline, it may interact with drugs that affect gastric pH (e.g., antacids, iron supplements, bismuth subsalicylate), which can reduce its absorption. It is also advised to use caution with other drugs that prolong the QT interval. Prescribers should consult the full prescribing information for a comprehensive list.

3. What are the most common side effects reported with NUZYRA? The most common adverse reactions reported in clinical trials include nausea, vomiting, diarrhea, headache, and infusion-site reactions. These are generally consistent with the known side effect profile of tetracycline antibiotics.

4. Does NUZYRA have an impact on the gut microbiome compared to other antibiotics? While specific comparative microbiome studies are ongoing, novel tetracyclines like omadacycline are designed with an aim to maintain a favorable safety profile. However, all broad-spectrum antibiotics can potentially disrupt the gut microbiome.

5. Is NUZYRA available outside of the United States? Paratek Pharmaceuticals has pursued international commercialization strategies. For example, a joint venture called SGM-Paratek was established for the commercialization of NUZYRA in China. Availability in other regions depends on regulatory approvals and commercial partnerships.

Citations

[1] Paratek Pharmaceuticals. (2023). Investor Relations Presentations and Reports. (Specific presentation or report details would be cited if available, e.g., Q3 2023 Earnings Call Transcript).

[2] FDA. (2018, October 2). FDA approves NUZYRA (omadacycline) for the treatment of adult patients with acute bacterial skin and skin structure infections. [Press Release].

[3] FDA. (2019, June 27). FDA approves NUZYRA (omadacycline) for the treatment of community-acquired bacterial pneumonia. [Press Release].

[4] Data on file, Paratek Pharmaceuticals. (Referencing clinical trial results).