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TOBI PODHALER Drug 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 twelve patents protecting this drug.
This drug has two hundred and forty-four patent family members in forty-three countries.
The generic ingredient in TOBI PODHALER is tobramycin. There are eighteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the tobramycin profile page.
US ANDA 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: | 244 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 69 |
| Clinical Trials: | 8 |
| Patent Applications: | 2,346 |
| 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 |
| 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 |
| Cystic Fibrosis Foundation Therapeutics | N/A |
| Novartis Pharmaceuticals | N/A |
Pharmacology for TOBI PODHALER
| Drug Class | Aminoglycoside Antibacterial |
US Patents and Regulatory Information for TOBI PODHALER
| 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 | Start Trial | Start Trial | Y | Start Trial | |||
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | RX | Yes | Yes | Start Trial | 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 |
|---|---|---|---|---|---|---|---|
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | Start Trial | Start Trial |
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | Start Trial | Start Trial |
| Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TOBI PODHALER
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 336171 | Start Trial |
| Canada | 2382133 | Start Trial |
| Canada | 2432319 | Start Trial |
| Portugal | 941067 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for TOBI PODHALER
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1280520 | C01280520/01 | Switzerland | Start Trial | PRODUCT NAME: TOBRAMYCIN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 60565 01.02.2012 |
| 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 | 122015000021 | Germany | Start Trial | PRODUCT NAME: TOBRAMYCIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/10/652/001-003 20110720 |
| 1280520 | C300722 | Netherlands | Start Trial | PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
