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 29th, 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 |
Recent Clinical Trials for BETHKIS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Cystic Fibrosis Foundation | |
| Mylan Inc. | |
| Cystic Fibrosis Foundation Therapeutics |
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
| 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 |
|---|---|---|---|
| China | 1529589 | ⤷ Sign Up | |
| China | 1234346 | ⤷ Sign Up | |
| Brazil | PI0211320 | Formulação de tobramicina para aerossolização | ⤷ Sign Up |
| Australia | 2002319226 | ⤷ Sign Up | |
| Estonia | 200400050 | ⤷ Sign Up | |
| Bulgaria | 108475 | ⤷ 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 | 14/2015 | Austria | ⤷ Sign Up | PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION 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 |
| 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 |
| 1280520 | 92678 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725 |
| 1273292 | C01273292/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009 |
| >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.
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