Amikacin sulfate - Generic Drug Details
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What are the generic sources for amikacin sulfate and what is the scope of patent protection?
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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Amikacin sulfate has two hundred and seven 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: | 207 |
US Patents: | 13 |
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: | 7,305 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apothecon | AMIKIN | amikacin sulfate | INJECTABLE;INJECTION | 062311-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Meitheal | AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 064045-002 | Sep 28, 1993 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Hikma | AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 063313-001 | Apr 11, 1994 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Igi Labs Inc | AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 063167-001 | Dec 14, 1995 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Apothecon | AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | amikacin sulfate | INJECTABLE;INJECTION | 050618-002 | Nov 30, 1987 | 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 |
---|---|---|---|
Japan | 2023021248 | 肺感染症を処置するためのシステム | ⤷ Sign Up |
Spain | 2539591 | ⤷ Sign Up | |
Portugal | 3142643 | ⤷ Sign Up | |
Spain | 2820226 | ⤷ Sign Up | |
European Patent Office | 3766501 | MÉTHODES DE TRAITEMENT D'INFECTIONS PULMONAIRES MYCOBACTÉRIENNES NON-TUBERCULEUSES (METHODS FOR TREATING PULMONARY NON-TUBERCULOUS MYCOBACTERIAL INFECTIONS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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