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ARIKAYCE KIT Drug Profile
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Which patents cover Arikayce Kit, and when can generic versions of Arikayce Kit launch?
Arikayce Kit is a drug marketed by Insmed Inc and is included in one NDA. There are ten patents protecting this drug.
This drug has one hundred and fifty-three patent family members in twenty-nine countries.
The generic ingredient in ARIKAYCE KIT is amikacin sulfate. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.
US ANDA Litigation and Generic Entry Outlook for Arikayce Kit
A generic version of ARIKAYCE KIT was approved as amikacin sulfate by WEST-WARD PHARMS INT on January 24th, 2020.
Summary for ARIKAYCE KIT
| International Patents: | 153 |
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Clinical Trials: | 4 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | ARIKAYCE KIT at DailyMed |
Recent Clinical Trials for ARIKAYCE KIT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | Phase 2 |
| Insmed Incorporated | Phase 2 |
| Insmed Incorporated | Phase 3 |
Pharmacology for ARIKAYCE KIT
| Drug Class | Aminoglycoside Antibacterial |
US Patents and Regulatory Information for ARIKAYCE KIT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 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 ARIKAYCE KIT
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2614764 | Start Trial |
| Japan | 2006514682 | Start Trial |
| Montenegro | 00597 | Start Trial |
| Japan | 5415759 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
