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-four patent family members in forty countries.
The generic ingredient in NUZYRA is omadacycline tosylate. Additional details are available on the omadacycline tosylate profile page.
DrugPatentWatch® Generic Entry Outlook for Nuzyra
Nuzyra will be eligible for patent challenges on October 2, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
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: | 234 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 24 |
| Clinical Trials: | 5 |
| Patent Applications: | 157 |
| Drug Prices: | Drug price information for NUZYRA |
| What excipients (inactive ingredients) are in NUZYRA? | NUZYRA excipients list |
| DailyMed Link: | NUZYRA at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity 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 |
| Paratek Pharmaceuticals Inc | Phase 1 |
| Hartford Hospital | Phase 1 |
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 See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SUBJECTS HAVING BACTERIAL SKIN OR SKIN STRUCTURE INFECTION
Minocycline compounds and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
Amino-methyl substituted tetracycline compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
9-aminomethyl substituted minocycline compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Salts and polymorphs of 9-(2,2-dimethylpropyl-aminomethyl) minocycline
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Minocycline compounds and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Minocycline compounds and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
Oral and injectable formulations of tetracycline compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Minocycline compounds and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
FDA Regulatory Exclusivity protecting NUZYRA
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing |
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | TABLET;ORAL | 209816-001 | Oct 2, 2018 | See Plans and Pricing | See Plans and Pricing |
| >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: See Plans and Pricing
Australia
Patent: 09229174
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0909211
Estimated Expiration: See Plans and Pricing
Patent: 2020011180
Estimated Expiration: See Plans and Pricing
Canada
Patent: 19751
Estimated Expiration: See Plans and Pricing
Patent: 84301
Estimated Expiration: See Plans and Pricing
Chile
Patent: 10000281
Estimated Expiration: See Plans and Pricing
China
Patent: 2046177
Estimated Expiration: See Plans and Pricing
Colombia
Patent: 00935
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0180836
Estimated Expiration: See Plans and Pricing
Patent: 0201883
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 20240
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 71348
Estimated Expiration: See Plans and Pricing
Patent: 48258
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 10010576
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 71348
Estimated Expiration: See Plans and Pricing
Patent: 48258
Estimated Expiration: See Plans and Pricing
Patent: 89030
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 57928
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 38257
Estimated Expiration: See Plans and Pricing
Patent: 52201
Estimated Expiration: See Plans and Pricing
Israel
Patent: 8440
Estimated Expiration: See Plans and Pricing
Japan
Patent: 40119
Estimated Expiration: See Plans and Pricing
Patent: 12521
Estimated Expiration: See Plans and Pricing
Patent: 77645
Estimated Expiration: See Plans and Pricing
Patent: 11515473
Estimated Expiration: See Plans and Pricing
Patent: 14221820
Estimated Expiration: See Plans and Pricing
Patent: 16145260
Estimated Expiration: See Plans and Pricing
Patent: 18203778
Estimated Expiration: See Plans and Pricing
Patent: 19196408
Estimated Expiration: See Plans and Pricing
Patent: 21167355
Estimated Expiration: See Plans and Pricing
Lithuania
Patent: 71348
Estimated Expiration: See Plans and Pricing
Patent: 48258
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 10010585
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 275
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 8428
Estimated Expiration: See Plans and Pricing
Norway
Patent: 71348
Estimated Expiration: See Plans and Pricing
Poland
Patent: 71348
Estimated Expiration: See Plans and Pricing
Patent: 48258
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 71348
Estimated Expiration: See Plans and Pricing
Patent: 48258
Estimated Expiration: See Plans and Pricing
Russian Federation
Patent: 10144130
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 71348
Estimated Expiration: See Plans and Pricing
Patent: 48258
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1007013
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1746228
Estimated Expiration: See Plans and Pricing
Patent: 1835574
Estimated Expiration: See Plans and Pricing
Patent: 1893740
Estimated Expiration: See Plans and Pricing
Patent: 110008057
Estimated Expiration: See Plans and Pricing
Patent: 160105532
Estimated Expiration: See Plans and Pricing
Patent: 180026799
Estimated Expiration: See Plans and Pricing
Spain
Patent: 74708
Estimated Expiration: See Plans and Pricing
Patent: 36448
Estimated Expiration: See Plans and Pricing
Tunisia
Patent: 10000445
Estimated Expiration: See Plans and Pricing
Turkey
Patent: 1806893
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 9627
Estimated Expiration: See Plans and Pricing
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 |
|---|---|---|---|
| Taiwan | I299038 | See Plans and Pricing | |
| Brazil | PI0112269 | composto de minociclina 9-aminometila substituída, e, composição farmacêutica | See Plans and Pricing |
| Colombia | 6300898 | SALES Y POLIMORFOS DE 9-(2,2-DIMETIL-PROPIL-AMINOMETIL)-MINOCICLINA | See Plans and Pricing |
| World Intellectual Property Organization (WIPO) | 2009120389 | See Plans and Pricing | |
| Poland | 2271348 | See Plans and Pricing | |
| Denmark | 2296464 | See Plans and Pricing | |
| Brazil | PI0909211 | formulação orais e injetáveis de composto de tetraciclina | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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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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