Amikacin sulfate - Generic Drug Details
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What are the generic drug 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 thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.Amikacin sulfate has two hundred and nine patent family members in thirty countries.
There are nine drug master file entries for amikacin sulfate. Six suppliers are listed for this compound.
Summary for amikacin sulfate
International Patents: | 209 |
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: | 5 |
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 | 8,679,532 | ⤷ Try for Free | ⤷ Try for Free | ||||
Apothecon | AMIKIN | amikacin sulfate | INJECTABLE;INJECTION | 050495-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Hikma | AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 063313-001 | Apr 11, 1994 | RX | No | Yes | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | RX | Yes | Yes | 11,446,318 | ⤷ Try for Free | ⤷ Try for Free | ||||
Apothecon | AMIKIN | amikacin sulfate | INJECTABLE;INJECTION | 062311-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | RX | Yes | Yes | 9,827,317 | ⤷ Try for Free | Y | ⤷ Try for Free | |||
>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 | 8,802,137 | ⤷ Try for Free |
Insmed Inc | ARIKAYCE KIT | amikacin sulfate | SUSPENSION, LIPOSOMAL;INHALATION | 207356-001 | Sep 28, 2018 | 9,827,317 | ⤷ Try for Free |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for amikacin sulfate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1118059 | ⤷ Try for Free | |
Canada | 2646255 | 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) | ⤷ Try for Free |
South Korea | 20220136448 | ⤷ Try for Free | |
European Patent Office | 3766501 | MÉTHODES DE TRAITEMENT D'INFECTIONS PULMONAIRES MYCOBACTÉRIENNES NON-TUBERCULEUSES (METHODS FOR TREATING PULMONARY NON-TUBERCULOUS MYCOBACTERIAL INFECTIONS) | ⤷ Try for Free |
Israel | 216401 | תכשיר אנטי-זיהומי המכיל אמיקצין ותערובת שומנים ושיטה להכנתו (Antiinfective formulation comprising amikacin and a lipid mixture and method of its preparation) | ⤷ Try for Free |
Costa Rica | 9736 | LIBERACION SOSTENIDA DE AGENTES ANTIINFECCIOSOS | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for Amikacin Sulfate
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