TOBRAMYCIN - Generic Drug Details

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

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-five 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:	35
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	124
Patent Applications:	6,911
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

See drug sales revenues for TOBRAMYCIN

Recent Clinical Trials for TOBRAMYCIN

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

Sponsor	Phase
Clarametyx Biosciences, Inc.	Phase 1/Phase 2
Shanghai Pulmonary Hospital, Shanghai, China	Phase 4
University of Utah	Early Phase 1

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
Hikma	TOBRAMYCIN SULFATE	tobramycin sulfate	INJECTABLE;INJECTION	063118-001	Jul 29, 1991		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hospira	TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	tobramycin sulfate	INJECTABLE;INJECTION	063081-006	Jun 2, 1993		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	TOBRAMYCIN	tobramycin	SOLUTION;INHALATION	091589-001	Oct 10, 2013	AN	RX	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

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	⤷ Sign Up	⤷ Sign Up
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	TOBI PODHALER	tobramycin	POWDER;INHALATION	201688-001	Mar 22, 2013	⤷ Sign Up	⤷ Sign Up
>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
Slovenia	1610850		⤷ Sign Up
Japan	2012107047	METHOD OF TREATMENT OF ENDOBRONCHIAL INFECTION	⤷ Sign Up
Mexico	PA06014567	METODO PARA EL TRATAMIENTO DE INFECCIONES ENDOBRONQUIALES. (METHODS OF TREATMENT OF ENDOBRONCHIAL INFECTIONS.)	⤷ Sign Up
>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	⤷ Sign Up	PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520	C300722	Netherlands	⤷ Sign Up	PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520	CA 2015 00017	Denmark	⤷ Sign Up	PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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