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 Inc and is included in two NDAs. There are nine patents protecting this drug.

This drug has two hundred and fifty-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.

Indicators of Generic Entry

Summary for NUZYRA

International Patents:	251
US Patents:	9
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	36
Clinical Trials:	5
Patent Applications:	122
Drug Prices:	Drug price information 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 Inc	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018		RX	Yes	Yes
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018		RX	Yes	Yes
Paratek Pharms Inc	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 Inc	NUZYRA	omadacycline tosylate	POWDER;INTRAVENOUS	209817-001	Oct 2, 2018
Paratek Pharms Inc	NUZYRA	omadacycline tosylate	TABLET;ORAL	209816-001	Oct 2, 2018
Paratek Pharms Inc	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
Japan	2016145260	テトラサイクリン化合物の経口製剤および注射可能な製剤 (ORAL AND INJECTABLE FORMULATION OF TETRACYCLINE COMPOUND)
Ecuador	SP10010576	FORMULACIONES ORALES E INYECTABLES DE COMPUESTOS DE TETRACICLINA
Chile	2010000281	Formulacion oral en forma de tableta de 9-[(2,2-dimetil-propilamino)-metil]-minociclina; metodo de preparacion; formulacion inyectable del mismo; utiles en el tratamiento de una infeccion.

Market Dynamics and Financial Trajectory of NUZYRA

Introduction to NUZYRA

NUZYRA, or omadacycline, is a broad-spectrum, novel antibiotic developed by Paratek Pharmaceuticals. It is approved by the U.S. Food and Drug Administration (FDA) for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI)[1][4].

FDA Approval and Indications

NUZYRA was FDA-approved in 2018 for the treatment of CABP and ABSSSI. It is available in both intravenous and oral formulations, offering flexibility in treatment settings. The oral-only dosing regimen for CABP is particularly significant, as it expands the commercial opportunity for primary care promotion and potentially reduces hospitalizations[4].

Market Potential

The market potential for NUZYRA is substantial. For CABP, the primary care market opportunity is estimated at approximately $1.5 billion. This indicates a significant commercial opportunity, especially given the drug's oral-only dosing regimen[4].

Financial Performance

In 2022, NUZYRA generated full-year net U.S. sales of $136.8 million, with $98.7 million coming from the core commercial business, representing a 45% increase over the prior year. An additional $38.1 million was derived from the second procurement of NUZYRA under the BARDA Project BioShield contract. This procurement is part of a larger contract valued at up to $304 million, which also supports the development of NUZYRA for the treatment and prophylaxis of pulmonary anthrax[2][5].

Revenue Breakdown

• Core Commercial Business: $98.7 million in 2022, a 45% increase from the prior year.
• BARDA Contract: $38.1 million from the second procurement under the BARDA Project BioShield contract.
• Government Contract and Grant Revenue: $21.1 million, a 33% increase from the prior year.
• Collaboration and Royalty Revenue: $2.4 million, primarily from royalty revenues on sales of SEYSARA[2][5].

Onshoring and National Security

Paratek Pharmaceuticals has completed the onshoring of NUZYRA's supply and manufacturing capabilities in the U.S. This milestone is crucial as it reduces dependency on foreign production and decreases national security risks associated with antibiotic manufacturing. The onshoring process included the successful technology transfer and FDA approval for U.S. manufacturing of NUZYRA tablets, the active pharmaceutical ingredient (API), and the IV formulation[1].

Expansion into Rare Diseases

NUZYRA is also being studied for the treatment of non-tuberculous mycobacterial (NTM) pulmonary disease, a rare and difficult-to-treat condition. The Phase 2b study has shown promising results, with significant symptom improvement and reduction in bacterial load. If approved for NTM, analysts project that NUZYRA could generate up to $119 million in revenue by 2030, further elevating its market profile[3].

Safety and Regulatory Considerations

While the efficacy data for NUZYRA in NTM is encouraging, safety concerns, particularly gastrointestinal side effects, remain. These side effects led to treatment discontinuation in some patients, raising questions about the drug's tolerability in broader patient populations. Regulatory bodies will require a comprehensive risk-benefit analysis before any new approvals[3].

Strategic Moves and Investor Sentiment

The acquisition of Paratek Pharmaceuticals by Novo Holdings and Gurnet Point underscores confidence in NUZYRA's commercial viability. The positive data from the NTM study may spark increased investor interest, positioning Paratek as a highly sought-after asset in future mergers and acquisitions within the infectious disease market[3].

Commercial Impact

Analysts are optimistic about NUZYRA's market potential. The drug's ability to treat difficult-to-treat infections and its potential approval for NTM could make it a key player in the antibiotic market, contributing to steady revenue growth. The projected revenue of $119 million by 2030 may be conservative if NUZYRA secures a position as a first- or second-line therapy for NTM[3].

Key Takeaways

• Strong Financial Performance: NUZYRA generated $136.8 million in net U.S. sales in 2022, with significant growth from both core commercial business and BARDA contracts.
• Market Expansion: Potential approval for NTM could significantly elevate NUZYRA's market profile and revenue.
• Onshoring Milestone: Completed U.S. supply and manufacturing capabilities reduce national security risks and ensure a secure domestic supply chain.
• Safety Considerations: Regulatory approval will depend on a comprehensive risk-benefit analysis, particularly addressing gastrointestinal side effects.
• Strategic Acquisitions: Recent acquisitions indicate strong confidence in NUZYRA's commercial viability and future growth potential.

FAQs

1. What is NUZYRA used for?

   • NUZYRA is used for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI)[1][4].

2. What are the formulations of NUZYRA?

   • NUZYRA is available in both intravenous and oral formulations[1][4].

3. What is the significance of onshoring NUZYRA's manufacturing?

   • Onshoring reduces dependency on foreign production and decreases national security risks associated with antibiotic manufacturing[1].

4. What is the projected revenue for NUZYRA if approved for NTM?

   • Analysts project up to $119 million in revenue by 2030 if NUZYRA is approved for NTM[3].

5. Who has acquired Paratek Pharmaceuticals?

   • Paratek Pharmaceuticals was acquired by Novo Holdings and Gurnet Point, indicating confidence in NUZYRA's commercial viability[3].

Sources

1. Paratek Pharmaceuticals Announces Completion of U.S. Onshoring Program Making NUZYRA the Only Novel Antibiotic with Domestic Supply and Manufacturing Capabilities - Biospace.
2. Paratek Pharmaceuticals Announces Full-Year 2022 Revenue of $160.3 Million - Biospace.
3. Nuzyra Shows Promising Results in Tough-to-Treat NTM Lung Disease - CTOl Digital.
4. Paratek Pharmaceuticals Announces FDA Approval of NUZYRA® (omadacycline) Oral Only Dosing Regimen for the Treatment of Community-Acquired Bacterial Pneumonia (CABP) - Paratek Pharmaceuticals.
5. Paratek Pharmaceuticals Announces Full-Year 2022 Revenue of $160.3 Million - GlobeNewswire.