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-four 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 29th, 1993.
Summary for BETHKIS
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 78 |
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 |
![BETHKIS drug patent expirations Drug patent expirations by year for BETHKIS](/p/graph/s/t/BETHKIS-patent-expirations.png)
![Drug Prices for BETHKIS](/p/graph/drug-price/BETHKIS.png)
Recent Clinical Trials for BETHKIS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mylan Inc. | |
Cystic Fibrosis Foundation Therapeutics | |
Novartis Pharmaceuticals |
Pharmacology for BETHKIS
Drug Class | Aminoglycoside Antibacterial |
Anatomical Therapeutic Chemical (ATC) Classes for BETHKIS
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
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
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
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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20040018403 | ⤷ Sign Up | |
Slovakia | 16432003 | Aerosólový prostriedok a spôsob jeho výroby (Optimised formulation of tobramycin for aerosolisation) | ⤷ Sign Up |
Czech Republic | 20033580 | ⤷ Sign Up | |
Czech Republic | 299348 | Aerosolový prostredek (Aerosol formulation) | ⤷ Sign Up |
Egypt | 24019 | Optimised formulation of tobramycin for aerosolization | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BETHKIS
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1280520 | 92678 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725 |
1280520 | C01280520/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012 |
1280520 | 122015000021 | Germany | ⤷ Sign Up | PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720 |
1273292 | C01273292/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009 |
1280520 | 14/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |