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Last Updated: April 25, 2024

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, Epic Pharma Llc, Alcon Pharms Ltd, Alembic, Apotex Inc, Bausch And Lomb, Chartwell Rx, Gland Pharma Ltd, Somerset Theraps Llc, Sandoz, Chiesi, Pulmoflow Inc, Alkem Labs Ltd, Amneal Pharms, Dr Reddys Labs Sa, Hikma, Luoxin Aurovitas, Lupin, Mankind Pharma, Micro Labs, Mylan, Sun Pharm, Teva Pharms Usa, Lilly, Apothecon, Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Hainan Poly, Hospira, Igi Labs Inc, Mylan Labs Ltd, Watson Labs Inc, Xellia Pharms Aps, and Xgen Pharms, and is included in sixty-four NDAs. There are seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tobramycin has sixty-one patent family members in twenty-seven countries.

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

Summary for tobramycin

International Patents:	61
US Patents:	7
Tradenames:	11
Applicants:	36
NDAs:	64
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	121
Patent Applications:	6,924
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

Drug Sales Revenue Trends for tobramycin

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Recent Clinical Trials for tobramycin

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

Sponsor	Phase
University of Utah	Early Phase 1
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

Anatomical Therapeutic Chemical (ATC) Classes for tobramycin

J01GB	Other aminoglycosides
J01G	AMINOGLYCOSIDE ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alkem Labs Ltd	TOBRAMYCIN	tobramycin	SOLUTION;INHALATION	212848-001	Apr 1, 2021	AN	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sandoz	TOBREX	tobramycin	SOLUTION/DROPS;OPHTHALMIC	062535-001	Dec 13, 1984	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bausch And Lomb	TOBRAMYCIN	tobramycin	SOLUTION/DROPS;OPHTHALMIC	064052-001	Nov 29, 1993	AT	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	063117-001	Apr 26, 1991	AP	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lilly	NEBCIN	tobramycin sulfate	INJECTABLE;INJECTION	050477-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Xgen Pharms	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	065013-001	Aug 17, 2001	AP	RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for tobramycin

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

EU/EMA Drug Approvals for tobramycin

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Viatris Healthcare 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	no	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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for tobramycin

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Country	Patent Number	Title	Estimated Expiration
Russian Federation	2389477	СПОСОБЫ ЛЕЧЕНИЯ ЭНДОБРОНХИАЛЬНЫХ ЗАБОЛЕВАНИЙ (METHODS OF TREATING ENDOBRONCHIAL DISEASES)	⤷ Try a Trial
South Korea	20050119686	AEROSOLIZATION APPARATUS WITH CAPSULE PUNCTURE ALIGNMENT GUIDE	⤷ Try a Trial
Portugal	1610850		⤷ Try a Trial
Tunisia	SN06420	METHODS OF TREATMENT OF ENDOBRONCHIAL INFECTIONS	⤷ Try a Trial
Australia	2004229446	Aerosolization apparatus with air inlet shield	⤷ Try a Trial
Denmark	1615689		⤷ Try a Trial
Cyprus	1117408		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for tobramycin

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1280520	300722	Netherlands	⤷ Try a Trial	PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520	92678	Luxembourg	⤷ Try a Trial	PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
1280520	14/2015	Austria	⤷ Try a Trial	PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1280520	122015000021	Germany	⤷ Try a Trial	PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1280520	C300722	Netherlands	⤷ Try a Trial	PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520	CA 2015 00017	Denmark	⤷ Try a Trial	PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
1280520	C01280520/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.