TOBI PODHALER Drug Patent Profile
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When do Tobi Podhaler patents expire, and when can generic versions of Tobi Podhaler launch?
Tobi Podhaler is a drug marketed by Mylan Speciality Lp and is included in one NDA. There are seven patents protecting this drug.
This drug has sixty-one patent family members in twenty-seven countries.
The generic ingredient in TOBI PODHALER 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 Tobi Podhaler
A generic version of TOBI PODHALER was approved as tobramycin by BAUSCH AND LOMB on November 29th, 1993.
Summary for TOBI PODHALER
| International Patents: | 61 |
| US Patents: | 7 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 79 |
| Clinical Trials: | 8 |
| Patent Applications: | 4,240 |
| Formulation / Manufacturing: | see details |
| 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 |
Anatomical Therapeutic Chemical (ATC) Classes for TOBI PODHALER
US Patents and Regulatory Information for TOBI PODHALER
TOBI PODHALER is protected by seven US patents.
Patents protecting TOBI PODHALER
Aerosolization apparatus with capsule puncture alignment guide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
Aerosolization apparatus with feedback mechanism
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Patent Expiration: ⤷ Sign Up
Aerosolization apparatus with air inlet shield
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Patent Expiration: ⤷ Sign Up
Methods of treatment of endobronchial infections
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
Aerosolization apparatus with capsule puncturing member
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
Aerosolization apparatus with air inlet shield
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 TOBI PODHALER
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| >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/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 TOBI PODHALER
See the table below for patents covering TOBI PODHALER around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hong Kong | 1031680 | ⤷ Sign Up | |
| African Regional IP Organization (ARIPO) | 987 | Dispersible macromolecule compositions and methods for their preparation and use. | ⤷ Sign Up |
| Australia | 2003302274 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TOBI PODHALER
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1280520 | 300722 | 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 | 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 |
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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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