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Last Updated: December 23, 2024

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NUZYRA Drug Patent Profile


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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

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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
Drug patent expirations by year for NUZYRA
Drug Prices for NUZYRA

See drug prices for NUZYRA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NUZYRA
Generic Entry Dates for NUZYRA*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW
NDA:
Dosage:
POWDER;INTRAVENOUS
Generic Entry Dates for NUZYRA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Paratek Pharmaceuticals IncPhase 3
Hartford HospitalPhase 1
Paratek Pharmaceuticals IncPhase 1

See all NUZYRA clinical trials

Pharmacology for NUZYRA

US Patents and Regulatory Information for NUZYRA

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of NUZYRA is ⤷  Subscribe.

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Paratek Pharms Inc NUZYRA omadacycline tosylate TABLET;ORAL 209816-001 Oct 2, 2018 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Paratek Pharms Inc NUZYRA omadacycline tosylate POWDER;INTRAVENOUS 209817-001 Oct 2, 2018 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Paratek Pharms Inc NUZYRA omadacycline tosylate POWDER;INTRAVENOUS 209817-001 Oct 2, 2018 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NUZYRA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Paratek Pharms Inc NUZYRA omadacycline tosylate TABLET;ORAL 209816-001 Oct 2, 2018 ⤷  Subscribe ⤷  Subscribe
Paratek Pharms Inc NUZYRA omadacycline tosylate POWDER;INTRAVENOUS 209817-001 Oct 2, 2018 ⤷  Subscribe ⤷  Subscribe
Paratek Pharms Inc NUZYRA omadacycline tosylate TABLET;ORAL 209816-001 Oct 2, 2018 ⤷  Subscribe ⤷  Subscribe
Paratek Pharms Inc NUZYRA omadacycline tosylate POWDER;INTRAVENOUS 209817-001 Oct 2, 2018 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Patent: 6001
Patent: FORMULACIONES ORALES E INYECTABLES DE COMPUESTOS DE TETRACICLINA
Estimated Expiration: ⤷  Subscribe

Australia

Patent: 09229174
Patent: Oral and injectable formulations of tetracycline compounds
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 0909211
Patent: formulação orais e injetáveis de composto de tetraciclina
Estimated Expiration: ⤷  Subscribe

Patent: 2020011180
Patent: formulações injetáveis de compostos de tetraciclina
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 19751
Patent: PREPARATIONS ORALES ET INJECTABLES DE COMPOSES DE TETRACYCLINE (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Patent: 84301
Patent: PREPARATIONS ORALES ET INJECTABLES DE COMPOSES DE TETRACYCLINE (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Chile

Patent: 10000281
Patent: 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.
Estimated Expiration: ⤷  Subscribe

China

Patent: 2046177
Patent: Oral and injectable formulations of tetracycline compounds
Estimated Expiration: ⤷  Subscribe

Colombia

Patent: 00935
Patent: FORMULACIONES ORALES E INYECTABLES DE COMPUESTOS DE TETRACICLINA
Estimated Expiration: ⤷  Subscribe

Croatia

Patent: 0180836
Estimated Expiration: ⤷  Subscribe

Patent: 0201883
Estimated Expiration: ⤷  Subscribe

Cyprus

Patent: 20240
Estimated Expiration: ⤷  Subscribe

Patent: 23382
Estimated Expiration: ⤷  Subscribe

Denmark

Patent: 71348
Estimated Expiration: ⤷  Subscribe

Patent: 48258
Estimated Expiration: ⤷  Subscribe

Ecuador

Patent: 10010576
Patent: FORMULACIONES ORALES E INYECTABLES DE COMPUESTOS DE TETRACICLINA
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 71348
Patent: PRÉPARATION ORALE D'UN COMPOSÉ DE TÉTRACYCLINE EN FORME DE COMPRIMÉ (ORAL TABLET FORMULATION OF TETRACYCLINE COMPOUND)
Estimated Expiration: ⤷  Subscribe

Patent: 48258
Patent: FORMULATIONS ORALES ET INJECTABLES DE COMPOSÉS DE TÉTRACYCLINE (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Patent: 89030
Patent: FORMULATIONS ORALES ET INJECTABLES DE COMPOSÉS DE TÉTRACYCLINE (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Hong Kong

Patent: 57928
Patent: 四環素化合物的口服和注射製劑 (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Hungary

Patent: 38257
Estimated Expiration: ⤷  Subscribe

Patent: 52201
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 40119
Estimated Expiration: ⤷  Subscribe

Patent: 12521
Estimated Expiration: ⤷  Subscribe

Patent: 77645
Estimated Expiration: ⤷  Subscribe

Patent: 11515473
Estimated Expiration: ⤷  Subscribe

Patent: 14221820
Patent: 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 FORMULATIONS OF TETRACYCLINE COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Patent: 16145260
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Patent: 18203778
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Patent: 19196408
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Patent: 21167355
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Patent: 23144043
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Lithuania

Patent: 71348
Estimated Expiration: ⤷  Subscribe

Patent: 48258
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 10010585
Patent: FORMULACIONES ORALES E INYECTABLES DE COMPUESTOS DE TETRACICLINA. (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS.)
Estimated Expiration: ⤷  Subscribe

Morocco

Patent: 275
Patent: تحضيرات تأخد عن طريق الفم والحقن من مركبات ثلاثية الحلقية
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 8428
Patent: Oral and injectable formulations of the tetracycline compound 9-[(2,2-dimethyl-propylamino)-methyl]-minocycline
Estimated Expiration: ⤷  Subscribe

Norway

Patent: 71348
Estimated Expiration: ⤷  Subscribe

Poland

Patent: 71348
Estimated Expiration: ⤷  Subscribe

Patent: 48258
Estimated Expiration: ⤷  Subscribe

Portugal

Patent: 71348
Estimated Expiration: ⤷  Subscribe

Patent: 48258
Estimated Expiration: ⤷  Subscribe

Russian Federation

Patent: 10144130
Patent: ПЕРОРАЛЬНАЯ И ИНЪЕКЦИОННАЯ КОМПОЗИЦИИ 9-[(2,2-ДИМЕТИЛПРОПИЛАМИНО)МЕТИЛ]МИНОЦИКЛИНА И СПОСОБ ПОЛУЧЕНИЯ ПЕРОРАЛЬНОЙ КОМПОЗИЦИИ
Estimated Expiration: ⤷  Subscribe

Slovenia

Patent: 71348
Estimated Expiration: ⤷  Subscribe

Patent: 48258
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 1007013
Patent: ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 1746228
Estimated Expiration: ⤷  Subscribe

Patent: 1835574
Estimated Expiration: ⤷  Subscribe

Patent: 1893740
Estimated Expiration: ⤷  Subscribe

Patent: 110008057
Patent: ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS
Estimated Expiration: ⤷  Subscribe

Patent: 160105532
Patent: 테트라사이클린 화합물의 경구 및 주사가능한 제제 (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Patent: 180026799
Patent: 테트라사이클린 화합물의 경구 및 주사가능한 제제 (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS)
Estimated Expiration: ⤷  Subscribe

Spain

Patent: 74708
Estimated Expiration: ⤷  Subscribe

Patent: 36448
Estimated Expiration: ⤷  Subscribe

Tunisia

Patent: 10000445
Patent: ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS
Estimated Expiration: ⤷  Subscribe

Turkey

Patent: 1806893
Estimated Expiration: ⤷  Subscribe

Ukraine

Patent: 9627
Patent: КОМПОЗИЦІЇ ТЕТРАЦИКЛІНОВИХ СПОЛУК ДЛЯ ОРАЛЬНОГО ВВЕДЕННЯ ТА ІН'ЄКЦІЙ
Estimated Expiration: ⤷  Subscribe

Patent: 2762
Patent: ПЕРОРАЛЬНА КОМПОЗИЦІЯ 9-[(2,2-ДИМЕТИЛПРОПІЛАМІНО)-МЕТИЛ]-МІНОЦИКЛІНУ АБО ЙОГО СОЛІ, ТВЕРДА ПРЕСОВАНА ДОЗОВАНА ФОРМА, КОМПОЗИЦІЯ ДЛЯ ІН'ЄКЦІЙ, ЗАСТОСУВАННЯ ТА СПОСІБ ПРИГОТУВАННЯ ФАРМАЦЕВТИЧНОЇ КОМПОЗИЦІЇ
Estimated Expiration: ⤷  Subscribe

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
Czech Republic 303702 Minocyklinové slouceniny (Minocycline compounds) ⤷  Subscribe
Malaysia 197146 9-AMINOMETHYL MINOCYCLINE COMPOUNDS AND USES THEREOF ⤷  Subscribe
Eurasian Patent Organization 200401169 АМИНОМЕТИЛЗАМЕЩЕННЫЕ ТЕТРАЦИКЛИНОВЫЕ СОЕДИНЕНИЯ ⤷  Subscribe
Croatia P20150584 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

NUZYRA Market Analysis and Financial Projection Experimental

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.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.