TOBI PODHALER Drug Patent Profile
When do Tobi Podhaler patents expire, and when can generic versions of Tobi Podhaler launch?
Tobi Podhaler is a drug marketed by Viatris and is included in one NDA. There are two patents protecting this drug.
The generic ingredient in TOBI PODHALER is tobramycin. There is one drug master file entry 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 Tobi Podhaler
A generic version of TOBI PODHALER was approved as tobramycin by BAUSCH AND LOMB INC on November 29th, 1993.
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Questions you can ask:
- What is the 5 year forecast for TOBI PODHALER?
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- What is Average Wholesale Price for TOBI PODHALER?
Summary for TOBI PODHALER
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 70 |
| Clinical Trials: | 8 |
| Patent Applications: | 894 |
| Drug Prices: | Drug price information for TOBI PODHALER |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TOBI PODHALER |
| What excipients (inactive ingredients) are in TOBI PODHALER? | TOBI PODHALER excipients list |
| DailyMed Link: | TOBI PODHALER at DailyMed |
Recent Clinical Trials for TOBI PODHALER
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Medical Center Groningen | Phase 1/Phase 2 |
| Mylan Inc. | Phase 4 |
| Cystic Fibrosis Foundation Therapeutics |
Pharmacology for TOBI PODHALER
| Drug Class | Aminoglycoside Antibacterial |
US Patents and Regulatory Information for TOBI PODHALER
TOBI PODHALER is protected by two US patents.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Viatris | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | RX | Yes | Yes | 8,869,794 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Viatris | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | RX | Yes | Yes | 10,207,066 | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >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 TOBI PODHALER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viatris | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | 8,069,851 | ⤷ Start Trial |
| Viatris | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | 11,484,671 | ⤷ Start Trial |
| Viatris | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | 7,442,388 | ⤷ Start Trial |
| Viatris | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | 8,715,623 | ⤷ Start Trial |
| Viatris | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | RE47526 | ⤷ Start Trial |
| Viatris | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | 7,559,325 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for TOBI PODHALER
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Viatris Healthcare Limited | Tobi Podhaler | tobramycin | EMEA/H/C/002155Tobi 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/005086Vantobra 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/002633Vantobra 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 TOBI PODHALER
See the table below for patents covering TOBI PODHALER around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2004229512 | Aerosolization apparatus with capsule puncture alignment guide | ⤷ Start Trial |
| Canada | 2520265 | APPAREIL DE PULVERISATION EN AEROSOL COMPRENANT UN GUIDE D'ALIGNEMENT POUR PERFORER LA CAPSULE (AEROSOLIZATION APPARATUS WITH CAPSULE PUNCTURE ALIGNMENT GUIDE) | ⤷ Start Trial |
| Cyprus | 1117408 | ⤷ Start Trial | |
| Denmark | 1615689 | ⤷ Start Trial | |
| European Patent Office | 1615689 | APPAREIL DE PULVERISATION EN AEROSOL COMPRENANT UN GUIDE D'ALIGNEMENT POUR PERFORER LA CAPSULE (AEROSOLIZATION APPARATUS WITH CAPSULE PUNCTURE ALIGNMENT GUIDE) | ⤷ Start Trial |
| Spain | 2564165 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TOBI PODHALER
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1273292 | C01273292/01 | Switzerland | ⤷ Start Trial | PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC 58751 28.05.2009 |
| 1280520 | C300722 | Netherlands | ⤷ Start Trial | PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720 |
| 1280520 | CA 2015 00017 | Denmark | ⤷ Start Trial | PRODUCT NAME: TOBRAMYCIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/10/652/001-003 20110720 |
| 1280520 | 92678 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: TOBRAMYCINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE QUI EN DERIVE. FIRST REGISTRATION: 20110725 |
| 1280520 | 300722 | Netherlands | ⤷ Start Trial | PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720 |
| 1280520 | 14/2015 | Austria | ⤷ Start Trial | 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 |
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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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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