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Tobramycin - Generic Drug Details

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What are the generic drug sources for tobramycin and what is the scope of patent protection?

Tobramycin is the generic ingredient in eleven branded drugs marketed by Novartis, Mylan Speciality Lp, Akorn, Alcon Pharms Ltd, Alembic Pharms Ltd, Apotex Inc, Bausch And Lomb, Fera Pharms, Gland Pharma Ltd, Somerset Theraps Llc, Sandoz Inc, Chiesi, Pulmoflow Inc, Alkem Labs Ltd, Amneal Pharms, Dr Reddys Labs Sa, Luoxin Aurovitas, Lupin, Mylan, Sun Pharm, Teva Pharms Usa, Lilly, Apothecon, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Mylan Labs Ltd, Watson Labs Inc, West-ward Pharms Int, Xellia Pharms Aps, and Xgen Pharms, and is included in fifty-nine NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tobramycin has one hundred and sixteen patent family members in thirty-seven countries.

There are eighteen drug master file entries for tobramycin. Thirty-three suppliers are listed for this compound.

Summary for tobramycin

International Patents:	116
US Patents:	13
Tradenames:	11
Applicants:	32
NDAs:	59
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	33
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	112
Patent Applications:	5,654
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for tobramycin
Drug Sales Revenues:	Drug sales revenues for tobramycin
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tobramycin
What excipients (inactive ingredients) are in tobramycin?	tobramycin excipients list
DailyMed Link:	tobramycin at DailyMed

See drug prices for tobramycin

See drug sales revenues for tobramycin

Recent Clinical Trials for tobramycin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Arun Aneja	Phase 3
United States Department of Defense	Phase 3
M.D. Anderson Cancer Center	Phase 2

See all tobramycin clinical trials

Pharmacology for tobramycin

Drug Class

Aminoglycoside Antibacterial

Medical Subject Heading (MeSH) Categories for tobramycin

Anti-Bacterial Agents

Paragraph IV (Patent) Challenges for TOBRAMYCIN

Tradename	Dosage	Ingredient	NDA	Submissiondate
BETHKIS	SOLUTION;INHALATION	tobramycin	201820	2017-08-31
TOBI	SOLUTION;INHALATION	tobramycin	050753	2009-06-29

US Patents and Regulatory Information for tobramycin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Luoxin Aurovitas	TOBRAMYCIN	tobramycin	SOLUTION;INHALATION	210871-001	Jan 22, 2021		DISCN	No	No
Novartis	TOBREX	tobramycin	SOLUTION/DROPS;OPHTHALMIC	050541-001	Approved Prior to Jan 1, 1982	AT	RX	Yes	Yes
Hospira	TOBRAMYCIN SULFATE (PHARMACY BULK)	tobramycin sulfate	INJECTABLE;INJECTION	063116-001	May 18, 1992		DISCN	No	No
Lilly	NEBCIN	tobramycin sulfate	INJECTABLE;INJECTION	050519-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for tobramycin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013
Mylan Speciality Lp	TOBI	tobramycin	SOLUTION;INHALATION	050753-001	Dec 22, 1997
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013

International Patents for tobramycin

Country	Patent Number	Estimated Expiration
Germany	60103527
Spain	2383367
Australia	2002319226
Portugal	1458360

Supplementary Protection Certificates for tobramycin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1280520	C300722	Netherlands		PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520	300722	Netherlands		PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520	14/2015	Austria		PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1280520	CA 2015 00017	Denmark		PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720