ARIKAYCE KIT Drug Patent 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 eighty-six 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.
DrugPatentWatch® 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: | 186 |
| US Patents: | 11 |
| Applicants: | 1 |
| NDAs: | 1 |
| Clinical Trials: | 7 |
| 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 3 |
| Insmed Incorporated | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for ARIKAYCE KIT
US Patents and Regulatory Information for ARIKAYCE KIT
ARIKAYCE KIT is protected by eleven US patents and two FDA Regulatory Exclusivities.
Patents protecting ARIKAYCE KIT
Methods for treating pulmonary non-tuberculous mycobacterial infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN
Methods for treating pulmonary non-tuberculous mycobacterial infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN
Sustained release of antiinfectives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS WITH CYSTIC FIBROSIS AS PART OF A COMBINATION DRUG REGIMEN
Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
Sustained release of antiinfectives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION DRUG REGIMEN
Systems for treating pulmonary infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
Sustained release of antiinfectives
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
Methods for treating pulmonary non-tuberculous mycobacterial infections
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING MYCOBACTERIUM AVIUM COMPLEX (MAC) LUNG DISEASE IN NON-CYSTIC FIBROSIS ADULTS AS PART OF A COMBINATION ANTIBACTERIAL DRUG REGIMEN
FDA Regulatory Exclusivity protecting ARIKAYCE KIT
TX OF MAC LUNG DISEASE IN ADULTS WITH LIMITED OR NO ALTERNATIVE TX OPTIONS AS PART OF A COMBO ANTIBACTERIAL DRUG REGIMEN WHO DO NOT ACHIEVE NEGATIVE SPUTUM CULTURES AFTER A MINIMUM OF 6 CONSECUTIVE MONTHS OF A MULTIDRUG BACKGROUND REGIMEN THERAPY
Exclusivity Expiration: See Plans and Pricing
GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >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
See the table below for patents covering ARIKAYCE KIT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 2021143187 | 非結核性抗酸菌肺感染症を治療するための方法 (METHODS FOR TREATING PULMONARY NON-TUBERCULOUS MYCOBACTERIAL INFECTIONS) | See Plans and Pricing |
| Japan | 5415759 | See Plans and Pricing | |
| Japan | 6980745 | See Plans and Pricing | |
| Portugal | 3142643 | See Plans and Pricing | |
| Japan | 5118302 | See Plans and Pricing | |
| China | 103263387 | Sustained release of antiinfectives | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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