DrugPatentWatch Database Preview
NUZYRA Drug 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 eleven patents protecting this drug.
This drug has two hundred and twenty-three 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: | 223 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 2 |
| Bulk Api Vendors: | 19 |
| Clinical Trials: | 3 |
| Patent Applications: | 123 |
| 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 |
| Hartford Hospital | Phase 1 |
| Paratek Pharmaceuticals Inc | Phase 1 |
US Patents and Regulatory Information for NUZYRA
| 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 | Start Trial | Start Trial | Start Trial | ||||
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | TABLET;ORAL | 209816-001 | Oct 2, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | TABLET;ORAL | 209816-001 | Oct 2, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | POWDER;INTRAVENOUS | 209817-001 | Oct 2, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | POWDER;INTRAVENOUS | 209817-001 | Oct 2, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Paratek Pharms Inc | NUZYRA | omadacycline tosylate | TABLET;ORAL | 209816-001 | Oct 2, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for NUZYRA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | PI0112269 | Start Trial |
| Taiwan | 202021946 | Start Trial |
| South Korea | 101893740 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2009111064 | Start Trial |
| Brazil | 112019008897 | Start Trial |
| China | 100473644 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
