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POLYMYXIN B SULFATE - Generic Drug Details
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What are the generic drug sources for polymyxin b sulfate and what is the scope of patent protection?
Polymyxin b sulfate
is the generic ingredient in five branded drugs marketed by Glaxosmithkline, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Mylan Asi, West-ward Pharms Int, Xellia Pharms Aps, Xgen Pharms, X Gen Pharms, Paddock Llc, Allergan, Akorn Inc, Bausch And Lomb, and Sandoz Inc, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.There are twelve drug master file entries for polymyxin b sulfate. Six suppliers are listed for this compound.
Summary for POLYMYXIN B SULFATE
US Patents: | 0 |
Tradenames: | 5 |
Applicants: | 14 |
NDAs: | 14 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 62 |
Clinical Trials: | 4 |
Patent Applications: | 2 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in POLYMYXIN B SULFATE? | POLYMYXIN B SULFATE excipients list |
DailyMed Link: | POLYMYXIN B SULFATE at DailyMed |
Recent Clinical Trials for POLYMYXIN B SULFATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
DongGuk University | N/A |
Azidus Brasil | Phase 3 |
Chulalongkorn University | Phase 3 |
Pharmacology for POLYMYXIN B SULFATE
Drug Class | Polymyxin-class Antibacterial |
Medical Subject Heading (MeSH) Categories for POLYMYXIN B SULFATE
US Patents and Regulatory Information for POLYMYXIN B SULFATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Akorn Inc | TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE | polymyxin b sulfate; trimethoprim sulfate | SOLUTION/DROPS;OPHTHALMIC | 065006-001 | Dec 17, 1998 | AT | RX | No | No | Get Started Free | Get Started Free | Get Started Free | |||
Gland Pharma Ltd | POLYMYXIN B SULFATE | polymyxin b sulfate | INJECTABLE;INJECTION | 207322-001 | Apr 14, 2016 | AP | RX | No | Yes | Get Started Free | Get Started Free | Get Started Free | |||
West-ward Pharms Int | POLYMYXIN B SULFATE | polymyxin b sulfate | INJECTABLE;INJECTION | 060716-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | Get Started Free | Get Started Free | Get Started Free | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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