AMIKACIN SULFATE - Generic Drug Details
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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, Sagent Pharms Inc, Apothecon, and Insmed Inc, and is included in twenty-five 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 four patent family members in twenty-nine countries.
There are nine drug master file entries for amikacin sulfate. Five suppliers are listed for this compound.
Summary for AMIKACIN SULFATE
International Patents: | 204 |
US Patents: | 12 |
Tradenames: | 5 |
Applicants: | 10 |
NDAs: | 25 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 5 |
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
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 IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | amikacin sulfate | INJECTABLE;INJECTION | 050618-001 | Nov 30, 1987 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Apothecon | AMIKIN | amikacin sulfate | INJECTABLE;INJECTION | 062311-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Apothecon | AMIKIN | amikacin sulfate | INJECTABLE;INJECTION | 050495-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Meitheal | AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 064045-002 | Sep 28, 1993 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Apothecon | AMIKIN | amikacin sulfate | INJECTABLE;INJECTION | 062311-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hikma | AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 063274-001 | May 18, 1992 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sagent Pharms Inc | AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 203323-001 | May 12, 2016 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 AMIKACIN SULFATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2009536612 | ⤷ Try a Trial | |
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) | ⤷ Try a Trial |
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 a Trial |
Japan | 2016153431 | 脂質を用いた薬物製剤の高速送達とその処置方法 (HIGH-SPEED DELIVERY OF LIPID BASED DRUG FORMULATIONS, AND METHODS OF TREATMENT THEREOF) | ⤷ Try a Trial |
Cyprus | 1116410 | ⤷ Try a Trial | |
Lithuania | 2852391 | ⤷ Try a Trial | |
Croatia | P20201515 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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