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 ten patents protecting this drug.
This drug has two hundred and thirty-eight 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: | 238 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 29 |
| Clinical Trials: | 5 |
| Patent Applications: | 200 |
| 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
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
| Sponsor | Phase |
|---|---|
| Paratek Pharmaceuticals Inc | Phase 3 |
| Hartford Hospital | Phase 1 |
| Paratek Pharmaceuticals Inc | Phase 1 |
Pharmacology for NUZYRA
| Drug Class | Tetracycline-class Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for NUZYRA
US Patents and Regulatory Information for NUZYRA
NUZYRA is protected by eleven US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of NUZYRA is ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF SUBJECTS HAVING BACTERIAL SKIN OR SKIN STRUCTURE INFECTION
Minocycline compounds and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
Amino-methyl substituted tetracycline compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
9-aminomethyl substituted minocycline compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Salts and polymorphs of 9-(2,2-dimethylpropyl-aminomethyl) minocycline
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Minocycline compounds and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Minocycline compounds and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
Oral and injectable formulations of tetracycline compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Minocycline compounds and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
FDA Regulatory Exclusivity protecting NUZYRA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial |
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | TABLET;ORAL | 209816-001 | Oct 2, 2018 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 09229174
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0909211
Estimated Expiration: ⤷ Try a Trial
Patent: 2020011180
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 19751
Estimated Expiration: ⤷ Try a Trial
Patent: 84301
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 10000281
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2046177
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 00935
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0180836
Estimated Expiration: ⤷ Try a Trial
Patent: 0201883
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 20240
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 71348
Estimated Expiration: ⤷ Try a Trial
Patent: 48258
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 10010576
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 71348
Estimated Expiration: ⤷ Try a Trial
Patent: 48258
Estimated Expiration: ⤷ Try a Trial
Patent: 89030
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 57928
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 38257
Estimated Expiration: ⤷ Try a Trial
Patent: 52201
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 40119
Estimated Expiration: ⤷ Try a Trial
Patent: 12521
Estimated Expiration: ⤷ Try a Trial
Patent: 77645
Estimated Expiration: ⤷ Try a Trial
Patent: 11515473
Estimated Expiration: ⤷ Try a Trial
Patent: 14221820
Estimated Expiration: ⤷ Try a Trial
Patent: 16145260
Estimated Expiration: ⤷ Try a Trial
Patent: 18203778
Estimated Expiration: ⤷ Try a Trial
Patent: 19196408
Estimated Expiration: ⤷ Try a Trial
Patent: 21167355
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 71348
Estimated Expiration: ⤷ Try a Trial
Patent: 48258
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 10010585
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 275
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 8428
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 71348
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 71348
Estimated Expiration: ⤷ Try a Trial
Patent: 48258
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 71348
Estimated Expiration: ⤷ Try a Trial
Patent: 48258
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 10144130
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 71348
Estimated Expiration: ⤷ Try a Trial
Patent: 48258
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1007013
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1746228
Estimated Expiration: ⤷ Try a Trial
Patent: 1835574
Estimated Expiration: ⤷ Try a Trial
Patent: 1893740
Estimated Expiration: ⤷ Try a Trial
Patent: 110008057
Estimated Expiration: ⤷ Try a Trial
Patent: 160105532
Estimated Expiration: ⤷ Try a Trial
Patent: 180026799
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 74708
Estimated Expiration: ⤷ Try a Trial
Patent: 36448
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 10000445
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1806893
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 9627
Estimated Expiration: ⤷ Try a Trial
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 | 2014221820 | 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) | ⤷ Try a Trial |
| Japan | 2021011498 | テトラサイクリン化合物の塩および多型体 (SALTS AND POLYMORPHS OF TETRACYCLINE COMPOUND) | ⤷ Try a Trial |
| Japan | 4925549 | ⤷ Try a Trial | |
| European Patent Office | 3789030 | FORMULATIONS ORALES ET INJECTABLES DE COMPOSÉS DE TÉTRACYCLINE (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS) | ⤷ Try a Trial |
| Hong Kong | 1257928 | 四環素化合物的口服和注射製劑 (ORAL AND INJECTABLE FORMULATIONS OF TETRACYCLINE COMPOUNDS) | ⤷ Try a Trial |
| Argentina | 076001 | FORMULACIONES ORALES E INYECTABLES DE COMPUESTOS DE TETRACICLINA | ⤷ Try a Trial |
| Brazil | 112019008897 | método para tratar pneumonia bacteriana adquirida na comunidade. | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Serving leading biopharmaceutical companies globally:
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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