BETHKIS Drug Patent Profile

Which patents cover Bethkis, and what generic alternatives are available?

Bethkis is a drug marketed by Chiesi and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in twenty-six countries.

The generic ingredient in BETHKIS is tobramycin. There are eighteen drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the tobramycin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bethkis

A generic version of BETHKIS was approved as tobramycin by BAUSCH AND LOMB on November 29^th, 1993.

Summary for BETHKIS

International Patents:	37
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	77
Clinical Trials:	2
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for BETHKIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BETHKIS
What excipients (inactive ingredients) are in BETHKIS?	BETHKIS excipients list
DailyMed Link:	BETHKIS at DailyMed

See drug prices for BETHKIS

Recent Clinical Trials for BETHKIS

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

Sponsor	Phase
Mylan Inc.
Cystic Fibrosis Foundation Therapeutics
Novartis Pharmaceuticals

See all BETHKIS clinical trials

Pharmacology for BETHKIS

Drug Class

Aminoglycoside Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for BETHKIS

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 BETHKIS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BETHKIS	Inhalation Solution	tobramycin	300 mg/4 mL	201820	1	2017-08-31

US Patents and Regulatory Information for BETHKIS

BETHKIS is protected by three US patents.

Patents protecting BETHKIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012	AN	RX	Yes	Yes
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012	AN	RX	Yes	Yes			Y
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012	AN	RX	Yes	Yes			Y

Expired US Patents for BETHKIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012

EU/EMA Drug Approvals for BETHKIS

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	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 BETHKIS

See the table below for patents covering BETHKIS around the world.

Country	Patent Number	Title	Estimated Expiration
China	1529589
Brazil	PI0211320	Formulação de tobramicina para aerossolização
Japan	2004535454
Czech Republic	299348	Aerosolový prostredek (Aerosol formulation)
Slovakia	16432003	Aerosólový prostriedok a spôsob jeho výroby (Optimised formulation of tobramycin for aerosolisation)
Poland	367139

Supplementary Protection Certificates for BETHKIS

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	122015000021	Germany		PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720
1280520	C01280520/01	Switzerland		PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012
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	CA 2015 00017	Denmark		PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720