BETHKIS Drug Patent Profile

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

Bethkis is a drug marketed by Chiesi and is included in one NDA.

The generic ingredient in BETHKIS is tobramycin. There are eighteen drug master file entries for this compound. Thirty-six 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.

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Summary for BETHKIS

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	78
Clinical Trials:	2
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

Drug patent expirations by year for BETHKIS

Recent Clinical Trials for BETHKIS

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

Sponsor	Phase
Novartis Pharmaceuticals
Cystic Fibrosis Foundation
Mylan Inc.

See all BETHKIS clinical trials

Pharmacology for BETHKIS

Drug Class	Aminoglycoside Antibacterial

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

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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
Chiesi	BETHKIS	tobramycin	SOLUTION;INHALATION	201820-001	Oct 12, 2012	AN	RX	Yes	Yes	⤷ 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 BETHKIS

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

EU/EMA Drug Approvals for BETHKIS

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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 BETHKIS

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

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Country	Patent Number	Title	Estimated Expiration
Czech Republic	20033580		⤷ Sign Up
Estonia	05392	Aerosoolina manustatav optimeeritud tobram tsiinipreparaat	⤷ Sign Up
Czech Republic	299348	Aerosolový prostredek (Aerosol formulation)	⤷ Sign Up
Tunisia	SN03149	OPTIMISED FORMULATION OF TOBRAMYCIN FOR AEROSOLIZATION	⤷ Sign Up
South Korea	20040018403		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for BETHKIS

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1273292	C01273292/01	Switzerland	⤷ Sign Up	PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009
1280520	300722	Netherlands	⤷ Sign Up	PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720
1280520	92678	Luxembourg	⤷ Sign Up	PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725
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
1280520	C01280520/01	Switzerland	⤷ Sign Up	PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description