NUZYRA Drug Patent Profile
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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 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
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Summary for NUZYRA
| International Patents: | 250 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 36 |
| Clinical Trials: | 5 |
| Patent Applications: | 121 |
| Drug Prices: | Drug price information for NUZYRA |
| What excipients (inactive ingredients) are in NUZYRA? | NUZYRA excipients list |
| DailyMed Link: | NUZYRA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for NUZYRA
*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 |
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.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NUZYRA is ⤷ Sign Up.
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.
Patents protecting NUZYRA
9-aminomethyl minocycline compounds and uses thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SUBJECTS HAVING BACTERIAL SKIN OR SKIN STRUCTURE INFECTION
Minocycline compounds and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTION
9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP)
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
9-aminomethyl substituted minocycline compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Salts and polymorphs of 9-(2,2-dimethylpropyl-aminomethyl) minocycline
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Minocycline compounds and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Minocycline compounds and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
Oral and injectable formulations of tetracycline compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Minocycline compounds and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
FDA Regulatory Exclusivity protecting NUZYRA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | TABLET;ORAL | 209816-001 | Oct 2, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | POWDER;INTRAVENOUS | 209817-001 | Oct 2, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | POWDER;INTRAVENOUS | 209817-001 | Oct 2, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | TABLET;ORAL | 209816-001 | Oct 2, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | POWDER;INTRAVENOUS | 209817-001 | Oct 2, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | TABLET;ORAL | 209816-001 | Oct 2, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | POWDER;INTRAVENOUS | 209817-001 | Oct 2, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | POWDER;INTRAVENOUS | 209817-001 | Oct 2, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | TABLET;ORAL | 209816-001 | Oct 2, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Australia
Patent: 09229174
Patent: Oral and injectable formulations of tetracycline compounds
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0909211
Patent: formulação orais e injetáveis de composto de tetraciclina
Estimated Expiration: ⤷ Sign Up
Patent: 2020011180
Patent: formulações injetáveis de compostos de tetraciclina
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 19751
Patent: PREPARATIONS ORALES ET INJECTABLES DE COMPOSES DE TETRACYCLINE (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 84301
Patent: PREPARATIONS ORALES ET INJECTABLES DE COMPOSES DE TETRACYCLINE (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
China
Patent: 2046177
Patent: Oral and injectable formulations of tetracycline compounds
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 00935
Patent: FORMULACIONES ORALES E INYECTABLES DE COMPUESTOS DE TETRACICLINA
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0180836
Estimated Expiration: ⤷ Sign Up
Patent: 0201883
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 20240
Estimated Expiration: ⤷ Sign Up
Patent: 23382
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 71348
Estimated Expiration: ⤷ Sign Up
Patent: 48258
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 10010576
Patent: FORMULACIONES ORALES E INYECTABLES DE COMPUESTOS DE TETRACICLINA
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent: 48258
Patent: FORMULATIONS ORALES ET INJECTABLES DE COMPOSÉS DE TÉTRACYCLINE (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 89030
Patent: FORMULATIONS ORALES ET INJECTABLES DE COMPOSÉS DE TÉTRACYCLINE (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Hungary
Patent: 38257
Estimated Expiration: ⤷ Sign Up
Patent: 52201
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 40119
Estimated Expiration: ⤷ Sign Up
Patent: 12521
Estimated Expiration: ⤷ Sign Up
Patent: 77645
Estimated Expiration: ⤷ Sign Up
Patent: 11515473
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
Lithuania
Patent: 71348
Estimated Expiration: ⤷ Sign Up
Patent: 48258
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 10010585
Patent: FORMULACIONES ORALES E INYECTABLES DE COMPUESTOS DE TETRACICLINA. (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 275
Patent: تحضيرات تأخد عن طريق الفم والحقن من مركبات ثلاثية الحلقية
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 8428
Patent: Oral and injectable formulations of the tetracycline compound 9-[(2,2-dimethyl-propylamino)-methyl]-minocycline
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 71348
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 71348
Estimated Expiration: ⤷ Sign Up
Patent: 48258
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 71348
Estimated Expiration: ⤷ Sign Up
Patent: 48258
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 10144130
Patent: ПЕРОРАЛЬНАЯ И ИНЪЕКЦИОННАЯ КОМПОЗИЦИИ 9-[(2,2-ДИМЕТИЛПРОПИЛАМИНО)МЕТИЛ]МИНОЦИКЛИНА И СПОСОБ ПОЛУЧЕНИЯ ПЕРОРАЛЬНОЙ КОМПОЗИЦИИ
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 71348
Estimated Expiration: ⤷ Sign Up
Patent: 48258
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1007013
Patent: ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1746228
Estimated Expiration: ⤷ Sign Up
Patent: 1835574
Estimated Expiration: ⤷ Sign Up
Patent: 1893740
Estimated Expiration: ⤷ Sign Up
Patent: 110008057
Patent: ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS
Estimated Expiration: ⤷ Sign Up
Patent: 160105532
Patent: 테트라사이클린 화합물의 경구 및 주사가능한 제제 (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Patent: 180026799
Patent: 테트라사이클린 화합물의 경구 및 주사가능한 제제 (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 74708
Estimated Expiration: ⤷ Sign Up
Patent: 36448
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 10000445
Patent: ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS
Estimated Expiration: ⤷ Sign Up
Turkey
Patent: 1806893
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 9627
Patent: КОМПОЗИЦІЇ ТЕТРАЦИКЛІНОВИХ СПОЛУК ДЛЯ ОРАЛЬНОГО ВВЕДЕННЯ ТА ІН'ЄКЦІЙ
Estimated Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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 |
|---|---|---|---|
| Austria | 336481 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2018026987 | ⤷ Sign Up | |
| China | 109789153 | 9-氨基甲基米诺环素化合物及其用途 (9-AMINOMETHYL MINOCYCLINE COMPOUNDS AND USES THEREOF) | ⤷ Sign Up |
| Croatia | P20180836 | ⤷ Sign Up | |
| Eurasian Patent Organization | 200300135 | ЗАМЕЩЕННЫЕ СОЕДИНЕНИЯ МАТАЦИКЛИНА (ВАРИАНТЫ), ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ВАРИАНТЫ) И СПОСОБ ЛЕЧЕНИЯ ЧУВСТВИТЕЛЬНОГО К ТЕТРАЦИКЛИНУ СОСТОЯНИЯ МЛЕКОПИТАЮЩЕГО (ВАРИАНТЫ) | ⤷ Sign Up |
| Russian Federation | 2019113715 | 9-АМИНОМЕТИЛМИНОЦИКЛИНОВЫЕ СОЕДИНЕНИЯ И ИХ ПРИМЕНЕНИЕ ДЛЯ ЛЕЧЕНИИЯ ВНЕБОЛЬНИЧНОЙ БАКТЕРИАЛЬНОЙ ПНЕВМОНИИ(ВБП) | ⤷ Sign Up |
| Japan | 2011515473 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
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