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ARIKAYCE KIT Drug Profile
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When do Arikayce Kit patents expire, and what generic alternatives are available?
Arikayce Kit is a drug marketed by Insmed Inc and is included in one NDA. There are eleven patents protecting this drug.
This drug has one hundred and sixty-nine 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. Five 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 TEVA PHARMS USA on September 28th, 1993.
Summary for ARIKAYCE KIT
| International Patents: | 169 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 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 |
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 | 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 | ||||
| Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | RX | Yes | Yes | Start Trial | Start Trial | 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 |
|---|---|---|
| Mexico | 2016014921 | Start Trial |
| Spain | 2755941 | Start Trial |
| Japan | 6125676 | Start Trial |
| Canada | 2870860 | Start Trial |
| South Korea | 20130079559 | Start Trial |
| Slovenia | 1581236 | Start Trial |
| Hungary | E025491 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
