AMIKACIN SULFATE Drug Patent Profile
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When do Amikacin Sulfate patents expire, and when can generic versions of Amikacin Sulfate launch?
Amikacin Sulfate is a drug marketed by Abbott, Avet Lifesciences, Fresenius Kabi Usa, Hikma, Hospira, Igi Labs Inc, Meitheal, Qilu, and Sagent Pharms Inc. and is included in twenty-one NDAs.
The generic ingredient in AMIKACIN SULFATE is amikacin sulfate. There are fifteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the amikacin sulfate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Amikacin Sulfate
A generic version of AMIKACIN SULFATE was approved as amikacin sulfate by MEITHEAL on September 28th, 1993.
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Questions you can ask:
- What is the 5 year forecast for AMIKACIN SULFATE?
- What are the global sales for AMIKACIN SULFATE?
- What is Average Wholesale Price for AMIKACIN SULFATE?
Summary for AMIKACIN SULFATE
| US Patents: | 0 |
| Applicants: | 9 |
| NDAs: | 21 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 120 |
| Clinical Trials: | 5 |
| Patent Applications: | 4,414 |
| DailyMed Link: | AMIKACIN SULFATE at DailyMed |
Recent Clinical Trials for AMIKACIN SULFATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Alphacait, LLC | Phase 2 |
| Haining Health-Coming Biotech Co., Ltd. | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Abbott | AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 063265-001 | Nov 30, 1994 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Igi Labs Inc | AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 063169-001 | Dec 14, 1995 | DISCN | 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 | ||||
| Fresenius Kabi Usa | AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 205605-001 | Dec 9, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hospira | AMIKACIN SULFATE | amikacin sulfate | INJECTABLE;INJECTION | 063283-001 | Oct 31, 1994 | 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 |
