Arikayce Kit is a drug owned by Insmed Inc. It is protected by 12 US drug patents filed from 2018 to 2022. Out of these, 10 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 15, 2035. Details of Arikayce Kit's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8802137 | Sustained release of antiinfectives |
Apr, 2024
(3 months ago) |
Expired
|
| US9827317 | Sustained release of antiinfectives |
Apr, 2024
(3 months ago) |
Expired
|
| US7718189 | Sustained release of antiinfectives |
Jun, 2025
(10 months from now) | Active |
| US8632804 | Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof |
Dec, 2026
(2 years from now) | Active |
| US8679532 | Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof |
Dec, 2026
(2 years from now) | Active |
| US8642075 | Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof |
Dec, 2026
(2 years from now) | Active |
| US8226975 | Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof |
Aug, 2028
(4 years from now) | Active |
| US9566234 | Systems for treating pulmonary infections |
Jan, 2034
(9 years from now) | Active |
| US9895385 | Methods for treating pulmonary non-tuberculous mycobacterial infections |
May, 2035
(10 years from now) | Active |
| US11446318 | Methods for treating pulmonary non-tuberculous mycobacterial infections |
May, 2035
(10 years from now) | Active |
| US10251900 | Methods for treating pulmonary non-tuberculous mycobacterial infections |
May, 2035
(10 years from now) | Active |
| US10751355 | Methods for treating pulmonary non-tuberculous mycobacterial infections |
May, 2035
(10 years from now) | Active |
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 Arikayce Kit's patents.
Latest Legal Activities on Arikayce Kit's Patents
Given below is the list of recent legal activities going on the following patents of Arikayce Kit.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Notice of Final Determination- Ineligible | 07 Feb, 2024 | US8226975 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 Jan, 2024 | US10751355 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 19 Dec, 2023 | US8226975 |
| Post Issue Communication - Certificate of Correction | 12 Oct, 2022 | US9566234 |
| Patent Issue Date Used in PTA Calculation | 20 Sep, 2022 | US11446318 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Sep, 2022 | US10251900 |
| Recordation of Patent Grant Mailed | 20 Sep, 2022 | US11446318 |
| Email Notification | 01 Sep, 2022 | US11446318 |
| Issue Notification Mailed | 31 Aug, 2022 | US11446318 |
| Dispatch to FDC | 23 Aug, 2022 | US11446318 |
FDA has granted several exclusivities to Arikayce Kit. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Arikayce Kit, 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 Arikayce Kit.
Exclusivity Information
Arikayce Kit holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Arikayce Kit's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| Orphan Drug Exclusivity(ODE-214) | Sep 28, 2025 |
| Generating Antibiotic Incentives Now(GAIN) | Sep 28, 2030 |
Several oppositions have been filed on Arikayce Kit'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 Arikayce Kit's generic, the next section provides detailed information on ongoing and past EP oppositions related to Arikayce Kit patents.
Arikayce Kit's oppositions filed in EPO
Arikayce Kit has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 04, 2014, by Generics [Uk] Limited. This opposition was filed on patent number EP06787716A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP11159754A | Feb, 2016 | Generics [UK] Limited | Revoked |
| EP06787716A | Jun, 2014 | Generics [UK] Limited | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Arikayce Kit 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 Arikayce Kit's family patents as well as insights into ongoing legal events on those patents.
Arikayce Kit's family patents
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Generic Launch
Generic Release Date:
Arikayce Kit's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 15, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Arikayce Kit Generics:
Amikacin Sulfate is the generic name for the brand Arikayce Kit. 10 different companies have already filed for the generic of Arikayce Kit, with Hospira having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Arikayce Kit's generic
About Arikayce Kit
Arikayce Kit is a drug owned by Insmed Inc. It is used for treating Mycobacterium Avium Complex (MAC) lung disease in adults as part of a combination drug regimen. Arikayce Kit uses Amikacin Sulfate as an active ingredient. Arikayce Kit was launched by Insmed Inc in 2018.
Market Authorisation Date:
Arikayce Kit was approved by FDA for market use on 28 September, 2018.
Active Ingredient:
Arikayce Kit uses Amikacin Sulfate as the active ingredient. Check out other Drugs and Companies using Amikacin Sulfate ingredient
Treatment:
Arikayce Kit is used for treating Mycobacterium Avium Complex (MAC) lung disease in adults as part of a combination drug regimen.
Dosage:
Arikayce Kit is available in suspension, liposomal form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 590MG BASE/8.4ML | SUSPENSION, LIPOSOMAL | Prescription | INHALATION |