AMIKACIN SULFATE - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for amikacin sulfate and what is the scope of freedom to operate?
Amikacin sulfate
is the generic ingredient in five branded drugs marketed by Abbott, Avet Lifesciences, Fresenius Kabi Usa, Hikma, Hospira, Igi Labs Inc, Meitheal, Qilu, Sagent Pharms Inc, Apothecon, and Insmed Inc, and is included in twenty-six NDAs. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.Amikacin sulfate has two hundred and six patent family members in twenty-nine countries.
There are nine drug master file entries for amikacin sulfate. Six suppliers are listed for this compound.
Summary for AMIKACIN SULFATE
| International Patents: | 206 |
| US Patents: | 12 |
| Tradenames: | 5 |
| Applicants: | 11 |
| NDAs: | 26 |
| Drug Master File Entries: | 9 |
| Finished Product Suppliers / Packagers: | 6 |
| Raw Ingredient (Bulk) Api Vendors: | 120 |
| Clinical Trials: | 5 |
| Patent Applications: | 5 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in AMIKACIN SULFATE? | AMIKACIN SULFATE excipients list |
| DailyMed Link: | AMIKACIN SULFATE at DailyMed |
Recent Clinical Trials for AMIKACIN SULFATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
| Alphacait, LLC | Phase 2 |
| Insmed Incorporated | Phase 2 |
Pharmacology for AMIKACIN SULFATE
| Drug Class | Aminoglycoside Antibacterial |
Medical Subject Heading (MeSH) Categories for AMIKACIN SULFATE
Anatomical Therapeutic Chemical (ATC) Classes for AMIKACIN SULFATE
US Patents and Regulatory Information for AMIKACIN SULFATE
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Sagent Pharms Inc | AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 203323-001 | May 12, 2016 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apothecon | AMIKIN | amikacin sulfate | INJECTABLE;INJECTION | 062311-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Hospira | AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 064098-001 | Jun 26, 1995 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for AMIKACIN SULFATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AMIKACIN SULFATE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Honduras | 2008000084 | LIBERACION SOSTENIDA DE ANTIINFECIOSOS | ⤷ Sign Up |
| Slovenia | 3466432 | ⤷ Sign Up | |
| Spain | 2905368 | ⤷ Sign Up | |
| Canada | 2853611 | VITESSES D'ADMINISTRATION ELEVEES POUR PREPARATIONS MEDICAMENTEUSES LIPIDIQUES ET METHODES DE TRAITEMENT ASSOCIEES (HIGH DELIVERY RATES FOR LIPID BASED DRUG FORMULATIONS, AND METHODS OF TREATMENT THEREOF) | ⤷ Sign Up |
| Hong Kong | 1162303 | 持續釋放抗感染藥 (SUSTAINED RELEASE OF ANTIINFECTIVES) | ⤷ Sign Up |
| Cyprus | 1115006 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2024 - 2025
NCE-1 Patent Challenge Dates 2024 - 2025
Trigger-based marketing for the life sciences
Get DrugPatentWatch Business Intelligence Reports at Amazon.com
DrugChatter - AI-based answers to questions about drugs
RxJam - Digital Marketing for Life Sciences
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
See Primary Research Papers Citing DrugPatentWatch
Follow DrugPatentWatch:
