Nuzyra is a drug owned by Paratek Pharmaceuticals Inc. It is protected by 11 US drug patents filed from 2018 to 2021. Out of these, 9 drug patents are active and 2 have expired. Nuzyra's patents will be open to challenges from 03 October, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 31, 2037. Details of Nuzyra's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8383610 | Salts and polymorphs of 9-(2,2-dimethylpropyl-aminomethyl) minocycline |
Sep, 2030
(5 years from now) | Active |
| US7553828 | 9-aminomethyl substituted minocycline compounds |
Jun, 2025
(5 months from now) | Active |
| US7326696 | Amino-methyl substituted tetracycline compounds |
Sep, 2023
(1 year, 2 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10383884 | 9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP) |
Oct, 2037
(12 years from now) | Active |
| US10835542 | 9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP) |
Oct, 2037
(12 years from now) | Active |
| US10111890 | 9-aminomethyl minocycline compounds and uses thereof |
Aug, 2037
(12 years from now) | Active |
| US9314475 | Oral and injectable formulations of tetracycline compounds |
Mar, 2031
(6 years from now) | Active |
| US9265740 | Minocycline compounds and methods of use thereof |
Mar, 2029
(4 years from now) | Active |
| US9724358 | Minocycline compounds and methods of use thereof |
Mar, 2029
(4 years from now) | Active |
| US10124014 | Minocycline compounds and methods of use thereof |
Mar, 2029
(4 years from now) | Active |
| US9365500 | 9-aminomethyl substituted minocycline compounds |
Jun, 2021
(3 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Nuzyra's patents.
Latest Legal Activities on Nuzyra's Patents
Given below is the list of recent legal activities going on the following patents of Nuzyra.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 May, 2024 | US10835542 |
| Interim Patent Term Extension Granted Critical | 13 May, 2024 | US7553828 |
| Court Processing Terminated | 17 Apr, 2024 | US7553828 |
| transaction for FDA Determination of Regulatory Review Period | 18 Jan, 2024 | US7553828 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US7553828 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 Oct, 2023 | US9314475 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Feb, 2023 | US10383884 |
| Second letter to regulating agency to determine regulatory review period | 17 Feb, 2023 | US7553828 |
| Interim Patent Term Extension Granted Critical | 17 Feb, 2023 | US7553828 |
| Case Docketed to Examiner in GAU Critical | 05 Oct, 2022 | US7553828 |
FDA has granted several exclusivities to Nuzyra. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nuzyra, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Nuzyra.
Exclusivity Information
Nuzyra holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Nuzyra's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 02, 2023 |
| Generating Antibiotic Incentives Now(GAIN) | Oct 02, 2028 |
Several oppositions have been filed on Nuzyra's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Nuzyra's generic, the next section provides detailed information on ongoing and past EP oppositions related to Nuzyra patents.
Nuzyra's Oppositions Filed in EPO
Nuzyra has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on May 28, 2021, by Lederer & Keller Patentanwälte Partnerschaft Mbb. This opposition was filed on patent number EP18158017A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP18158017A | May, 2021 | Lederer & Keller Patentanwälte Partnerschaft mbB | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Nuzyra is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Nuzyra's family patents as well as insights into ongoing legal events on those patents.
Nuzyra's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nuzyra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 31, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nuzyra Generics:
There are no approved generic versions for Nuzyra as of now.
Alternative Brands for Nuzyra
Nuzyra which is used for treating bacterial skin and skin structure infections, and community-acquired bacterial pneumonia., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Melinta Therap |
| |||
About Nuzyra
Nuzyra is a drug owned by Paratek Pharmaceuticals Inc. It is used for treating bacterial skin and skin structure infections, and community-acquired bacterial pneumonia. Nuzyra uses Omadacycline Tosylate as an active ingredient. Nuzyra was launched by Paratek Pharms Inc in 2018.
Can you believe Nuzyra received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Approval Date:
Nuzyra was approved by FDA for market use on 02 October, 2018.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Nuzyra is 02 October, 2018, its NCE-1 date is estimated to be 03 October, 2027.
Active Ingredient:
Nuzyra uses Omadacycline Tosylate as the active ingredient. Check out other Drugs and Companies using Omadacycline Tosylate ingredient
Treatment:
Nuzyra is used for treating bacterial skin and skin structure infections, and community-acquired bacterial pneumonia.
Dosage:
Nuzyra is available in the following dosage forms - tablet form for oral use, powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 150MG BASE | TABLET | Prescription | ORAL |
| EQ 100MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |