TOBRAMYCIN SULFATE - Generic Drug Details

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What are the generic drug sources for tobramycin sulfate and what is the scope of freedom to operate?

Tobramycin sulfate is the generic ingredient in four branded drugs marketed by Lilly, Apothecon, Baxter Hlthcare Corp, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Hospira, Igi Labs Inc, Mylan Labs Ltd, Slate Run Pharma, Teva Pharms Usa, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for tobramycin sulfate. Eleven suppliers are listed for this compound.

Sponsor

Phase

Madonna Magdy Fahmy

Early Phase 1

Osteal Therapeutics, Inc.

Phase 2

Joint Purification Systems

Phase 2

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eugia Pharma	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	217519-001	Jun 21, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	TOBRAMYCIN SULFATE (PHARMACY BULK)	tobramycin sulfate	INJECTABLE;INJECTION	065120-001	Nov 29, 2002	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Igi Labs Inc	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	063121-001	Oct 31, 1994		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Igi Labs Inc	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	063120-001	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

US Patents:	0
Tradenames:	4
Applicants:	16
NDAs:	36
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	105
Clinical Trials:	5
Patent Applications:	6,777
What excipients (inactive ingredients) are in TOBRAMYCIN SULFATE?	TOBRAMYCIN SULFATE excipients list
DailyMed Link:	TOBRAMYCIN SULFATE at DailyMed