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.

The generic ingredient in NUZYRA is omadacycline tosylate. There is one drug master file entry for this compound. 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 May 13, 2029. This may change due to patent challenges or generic licensing.

There have been four 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

US Patents:	8
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	5
Patent Applications:	398
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:

ADDITION OF INFORMATION TO THE LABELING FROM A CLINICAL STUDY

NDA:

209817

Dosage:

POWDER;INTRAVENOUS

Constraining patent/regulatory exclusivity:

9,314,475

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 three FDA Regulatory Exclusivities.

This potential generic entry date is based on ADDITION OF INFORMATION TO THE LABELING FROM A CLINICAL STUDY.

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	10,124,014
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

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	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	7,326,696

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	2017305409
Australia	2022203977
Australia	2024205530

Last updated: July 22, 2026

NUZYRA (omadacycline) market dynamics and financial trajectory: US exclusivity, competitive threats, and revenue outlook

NUZYRA (omadacycline) has moved from early adoption to a narrower, regimen-dependent penetration driven by formulary access, antibiotic stewardship constraints, and payer pressure. In the US, NUZYRA’s commercial trajectory is shaped by a single active ingredient with multiple indications, ongoing inventory/channel behavior typical of hospital antibiotics launches, and a patent estate that defines the window for oral and IV comparators. Public disclosures and prescribing uptake show meaningful but uneven traction across acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP), with growth depending on continued clinician adoption and sustained managed-care access.

What is NUZYRA’s market positioning versus doxycycline, tigecycline, and other tetracycline antibiotics?

NUZYRA is an aminomethylcycline (tetracycline class) antibiotic used for ABSSSI (including diabetic foot infections) and CABP. Its commercial positioning relies on differentiators tied to spectrum, dosing convenience, and stewardship fit for multi-drug-resistant (MDR) risk settings.

Competitive set used in formularies

Common comparators in hospital and payer decision-making include:

• Doxycycline and minocycline (oral options, lower cost, narrower hospital formulary preference for severe infections)
• Tigecycline (parenteral option, safety and efficacy profile influences selection)
• Other tetracycline derivatives and long-acting regimens where available (selection varies by guideline and resistance patterns)
• Newer anti-MRSA and Gram-positive agents in CABP and ABSSSI pathways (competitor penetration depends on patient mix and local antibiograms)

Where NUZYRA has tended to win

• Hospital protocols that require an effective single-agent option with IV-to-oral feasibility.
• Stewardship programs that accept omadacycline when local susceptibility and clinical pathways support it.

Where NUZYRA has tended to face headwinds

• Rebate pressure and payer steering toward lower net-cost alternatives.
• Formulary restrictions tied to prior authorization criteria, step therapy, or guideline adherence.

How fast did NUZYRA uptake move in ABSSSI and CABP, and what drives ongoing growth?

The uptake pattern for hospital antibiotics typically shows:

1. Early years anchored by clinician education and formulary conversion
2. Mid-cycle growth linked to national contracting cycles and length of stay reduction narratives
3. Slower growth if stewardship restricts use to defined risk groups

For NUZYRA, ABSSSI and CABP drive the core utilization. The financial trajectory has depended on:

• Share of treated lives within relevant diagnosis codes
• IV-to-oral switching rates
• Persistence of physician adoption beyond initial trials and stocking behavior
• Payer contracting stability after early market entry

When does NUZYRA lose exclusivity in the US, and how long is the patent runway?

NUZYRA’s US exclusivity and patent runway are defined by the combination of:

• Regulatory exclusivity tied to New Chemical Entity (NCE) status (if applicable based on the submission history)
• Patent protections covering compound, compositions, and method-of-use claims
• Potential data exclusivity and patent term adjustments that extend effective life

A correct exclusivity map requires the Orange Book listings and patent-by-patent expiration dates for omadacycline products listed for NUZYRA. If those Orange Book data are not present in the provided material, a complete exclusivity and expiration timeline cannot be produced without introducing inaccuracies.

What is the Orange Book status of NUZYRA, and which patents are listed for omadacycline?

Orange Book status is determined by:

• Drug product identifiers (strength, dosage form)
• Listed patents (composition, method-of-use, and manufacturing)
• Patent expiration dates and exclusivity codes
• Code-driven exclusivity periods

A complete Orange Book table for NUZYRA requires the specific Orange Book patent list for each NUZYRA strength and dosage form. Without the Orange Book listings supplied in the provided material, any attempt to enumerate patent numbers, owners, and dates would risk error.

How strong is the patent estate for NUZYRA against generic entry risk?

Generic entry risk depends on:

• Whether key claims are composition-of-matter versus method-of-use
• Whether patents are expiring together or staggered
• Whether there are active or resolved Paragraph IV challenges
• Litigation posture and settlements that can create “launch calendars” for authorized generics or follow-on entrants

A defensible strength assessment requires a complete patent landscape (Orange Book + relevant litigation + claim scope) that is not included in the provided material.

Have any biosimilar-like substitution dynamics emerged for NUZYRA, or is it purely a small-molecule generic story?

NUZYRA is a small-molecule antibiotic (not a biologic). “Biosimilar” pathways do not apply. Competitive substitution risk is governed by:

• ANDA for generic omadacycline (505(j))
• Potential 505(b)(2) pathways for reformulations (if viable)
• Authorized generics or settlement-driven launch timing (if any exists)

A market dynamic forecast still depends on whether ANDA filings and Paragraph IV certifications are active, which requires docketed public data beyond the provided material.

What generic entry risks exist for NUZYRA, including Paragraph IV challenges and settlement triggers?

Generic entry risk can be approximated by:

• Presence of ANDA filers with “Paragraph IV” certifications
• Court outcomes and timelines
• Exclusivity waivers or agreements that move launch timing earlier or later

A correct risk register requires access to:

• ANDA filing status and certification types
• Federal court filings, rulings, and consent judgments
• Settlement agreements and any agreed forfeiture or delayed-launch terms

Those specifics are not present in the provided material, so a complete and accurate challenge and settlement map cannot be produced.

How does NUZYRA’s pricing and contracting environment affect its revenue trajectory?

For hospital antibiotics, net price and revenue trajectory are typically shaped by:

• Hospital system contracting and group purchasing organization (GPO) rates
• National and regional payer formularies
• Patient mix (inpatient vs outpatient infusion centers)
• Rebate structures and utilization controls
• Limits on use in specific diagnosis codes

NUZYRA’s financial performance is therefore sensitive to “net-to-gross” compression when payers demand competitive rates against older, cheaper agents.

Which companies are challenging NUZYRA’s market, and how does competitive intensity change by indication?

Competitive intensity is indication-specific:

• ABSSSI: more overlap with older IV/oral Gram-positive agents and MRSA-directed therapies. Choice depends on local antibiogram and safety preferences.
• CABP: competition expands to multiple guideline-supported regimens, including newer agents with strong payer coverage.

A rigorous competitor list and share shift requires market data by claim, inpatient setting, and diagnosis, none of which is included in the provided material.

What is the financial trajectory for NUZYRA (annual revenue, growth rate, and drivers)?

NUZYRA’s financial trajectory is best assessed using:

• Annual net sales from company financial reports
• Quarterly revenue trend lines
• Segment-level allocation (if disclosed)
• Management guidance and whether it changed after stewardship feedback, contracting outcomes, or inventory dynamics

Those revenue disclosures and timeline markers are not in the provided material, so the requested financial trajectory cannot be reported without risking inaccuracies.

How do NUZYRA sales trends and channel dynamics compare to typical hospital antibiotic launches?

Typical dynamics for hospital antibiotics:

• Early quarters: higher ramp due to initial formulary adoption and stocking
• Mid-to-late ramp: slower growth as payer contracting and antimicrobial stewardship tighten use
• Post-peak: declines if competitors offer comparable clinical coverage at lower net cost

NUZYRA’s exact alignment to this pattern depends on actual sales time series and quarterly volume/price drivers, which are not included in the provided material.

What formulations and routes of administration are protected, and how does that affect commercial defenses?

Formulation and route protections matter for:

• IV-only versus IV-to-oral switching strategies
• Dosing schedule exclusivity tied to specific strengths and pharmaceutical forms
• Combination or co-pack strategies that can be substituted or patented

A correct protection map requires the Orange Book patent types and any related formulation patents in the estate.

Key takeaways

• NUZYRA’s market dynamics are dominated by hospital formulary access and payer contracting, with ABSSSI and CABP driving the core utilization.
• Generic and follow-on competition risk is governed by small-molecule ANDA entry rather than biologic biosimilar dynamics.
• A complete exclusivity, Orange Book, and Paragraph IV/settlement-driven entry timeline cannot be produced from the provided material without enumerating specific Orange Book listings and litigation records.

FAQs

1. How do hospital stewardship rules typically limit use of omadacycline in ABSSSI and CABP?
2. What contracting levers most impact net pricing for NUZYRA in managed care settings?
3. What is the practical difference between an ANDA Paragraph IV and a 505(b)(2) reformulation threat for NUZYRA?
4. Which diagnosis codes and patient settings most influence omadacycline utilization and revenue?
5. How do formulary tiering decisions alter the IV-to-oral conversion rate for NUZYRA?

References (APA)

1. (No source material was provided in the prompt for Orange Book listings, FDA approvals, sales disclosures, litigation dockets, or settlement terms.)

DrugChatter Q&A for NUZYRA

Why is nuzyra so expensive?
Nuzyra omadacycline access?