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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, Somerset Theraps Llc, Sandoz Inc, Chiesi, Pulmoflow Inc, Akorn Inc, Amneal Pharms, Dr Reddys Labs Sa, 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-three NDAs. There are fifteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tobramycin has two hundred and eighty-one patent family members in forty-four countries.

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

Summary for tobramycin

International Patents:	281
US Patents:	15
Tradenames:	11
Applicants:	30
NDAs:	53
Drug Master File Entries:	18
Suppliers / Packagers:	30
Bulk Api Vendors:	66
Clinical Trials:	105
Patent Applications:	4,535
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
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
Atlantic Health System	Phase 4
Sutphin Drugs	Early Phase 1
University of Dundee	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
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes			Y
Baxter Hlthcare Corp	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	206965-001	Jul 1, 2016	AP	RX	No	No
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013		RX	Yes	Yes
Hospira	TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	tobramycin sulfate	INJECTABLE;INJECTION	063081-001	Jul 31, 1990		RX	No	Yes
Watson Labs Inc	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	062945-002	Aug 9, 1989		DISCN	No	No
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012		RX	Yes	Yes			Y

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
China	1741789
Spain	2383367
Australia	1064499
World Intellectual Property Organization (WIPO)	2004060903
Australia	2002245181
Japan	5952231

Supplementary Protection Certificates for tobramycin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1280520	CA 2015 00017	Denmark		PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
1280520	C300722	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	122015000021	Germany		PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1273292	C01273292/01	Switzerland		PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
1280520	C01280520/01	Switzerland		PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012