Tobramycin - Generic Drug Details

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, Mankind Pharma, Mylan, Sun Pharm, Teva Pharms Usa, Lilly, Apothecon, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hikma, Hospira, Igi Labs Inc, Mylan Labs Ltd, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in sixty NDAs. There are fourteen 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-six suppliers are listed for this compound.

Summary for tobramycin

International Patents:	116
US Patents:	14
Tradenames:	11
Applicants:	33
NDAs:	60
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	120
Patent Applications:	6,178
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
Medical University of South Carolina	Phase 4
Chris Goss	Phase 4
University of Washington	Phase 4

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	Strength	NDA	ANDAs Submitted	Submissiondate
BETHKIS	Inhalation Solution	tobramycin	300 mg/4 mL	201820	1	2017-08-31
TOBI	Inhalation Solution	tobramycin	300 mg/5 mL	050753	1	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	tobramycin	SOLUTION;INHALATION	050753-001	Dec 22, 1997	AN	RX	Yes	Yes
Hikma	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	063118-001	Jul 29, 1991		DISCN	No	No
Fresenius Kabi Usa	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	050789-001	Jul 13, 2004	AP	RX	No	No
Lupin	TOBRAMYCIN	tobramycin	SOLUTION;INHALATION	208964-001	Mar 22, 2017	AN	RX	No	No
Hikma	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	063128-001	Nov 27, 1991		DISCN	No	No

Expired US Patents for tobramycin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012
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
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013

EU/EMA Drug Approvals for tobramycin

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan Ireland Limited	Tobi Podhaler	tobramycin	EMEA/H/C/002155 Tobi Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. See sections 4.4 and 5.1 regarding data in different age groups.Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	yes	2011-07-20
Pari Pharma GmbH	Vantobra (previously Tobramycin PARI)	tobramycin	EMEA/H/C/005086 Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Authorised	no	no	no	2019-02-18
Pari Pharma GmbH	Vantobra	tobramycin	EMEA/H/C/002633 Vantobra is indicated for the management of chronic pulmonary infection due to Pseudomonas aeruginosa in patients aged 6 years and older with cystic fibrosis (CF).Consideration should be given to official guidance on the appropriate use of antibacterial agents.	Withdrawn	no	no	no	2015-03-18

International Patents for tobramycin

Country	Patent Number	Title	Estimated Expiration
Denmark	1765288
Canada	2520032	APPAREIL DE PULVERISATION EN AEROSOL ET ECRAN DE PROTECTION D'ENTREE D'AIR (AEROSOLIZATION APPARATUS WITH AIR INLET SHIELD)
Spain	2383367
Germany	60103527
Egypt	24019	Optimised formulation of tobramycin for aerosolization

Supplementary Protection Certificates for tobramycin

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1280520	14/2015	Austria		PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION 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	92678	Luxembourg		PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
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