Tobramycin Patent Expiration
Tobramycin is Used for treating cystic fibrosis patients infected with Pseudomonas aeruginosa. It was first introduced by Novartis Pharmaceuticals Corp
Tobramycin Patents
Given below is the list of patents protecting Tobramycin, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Tobi Podhaler | US10207066 | Aerosolization apparatus with capsule puncture alignment guide | Nov 04, 2030 | Mylan Speciality Lp |
| Tobi Podhaler | US8869794 | Aerosolization apparatus with capsule puncturing member | Sep 12, 2028 | Mylan Speciality Lp |
| Tobi Podhaler | US7559325 | Aerosolization apparatus with air inlet shield | Oct 27, 2025 | Mylan Speciality Lp |
| Tobi Podhaler | US8664187 | Methods of treatment of endobronchial infections | Jun 20, 2025 | Mylan Speciality Lp |
| Tobi Podhaler | US11484671 | Aerosolization apparatus with capsule puncture alignment guide |
Nov 07, 2024
(Expired) | Mylan Speciality Lp |
| Tobi Podhaler | US8069851 | Aeorosolization apparatus with air inlet shield |
Sep 24, 2024
(Expired) | Mylan Speciality Lp |
| Tobi Podhaler | USRE47526 | Aerosolization apparatus with air inlet shield |
Apr 09, 2024
(Expired) | Mylan Speciality Lp |
| Tobi Podhaler | US7516741 | Aerosolization apparatus with feedback mechanism |
Jan 11, 2024
(Expired) | Mylan Speciality Lp |
| Bethkis | US7696178 | Optimised formulation of tobramycin for aerosolization |
Mar 17, 2023
(Expired) | Chiesi |
| Tobi Podhaler | US7368102 | Pulmonary delivery of aminoglycosides |
Dec 19, 2022
(Expired) | Mylan Speciality Lp |
| Tobi Podhaler | US8715623 | Pulmonary delivery of aminoglycoside |
Dec 19, 2022
(Expired) | Mylan Speciality Lp |
| Tobi Podhaler | US9421166 | Pulmonary delivery of aminoglycoside |
Dec 19, 2022
(Expired) | Mylan Speciality Lp |
| Bethkis | US6987094 | Optimized formulation of tobramycin for aerosolization |
Sep 22, 2022
(Expired) | Chiesi |
| Bethkis | US7939502 | Optimised formulation of tobramycin for aerosolization |
Jun 14, 2022
(Expired) | Chiesi |
| Tobi Podhaler | US7097827 | Devices, compositions and methods for the pulmonary delivery of aerosolized medicaments |
Jun 27, 2021
(Expired) | Mylan Speciality Lp |
| Tobi Podhaler | US7442388 | Phospholipid-based powders for drug delivery |
May 10, 2020
(Expired) | Mylan Speciality Lp |
| Tobi Podhaler | US8349294 | Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use |
May 10, 2020
(Expired) | Mylan Speciality Lp |
| Tobi | US5508269 | Aminoglycoside formulation for aerosolization |
Oct 19, 2014
(Expired) | Mylan Speciality Lp |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Tobramycin's patents.
Latest Legal Activities on Tobramycin's Patents
Given below is the list recent legal activities going on the following patents of Tobramycin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Court Processing Terminated | 17 Apr, 2024 | US7516741 |
| Maintenance Fee Reminder Mailed Critical | 15 Apr, 2024 | US9421166 |
| Court Processing Terminated | 01 Mar, 2024 | US7097827 |
| Court Processing Terminated | 28 Feb, 2024 | US7442388 |
| Recordation of Patent Grant Mailed Critical | 01 Nov, 2022 | US11484671 |
| Patent Issue Date Used in PTA Calculation Critical | 01 Nov, 2022 | US11484671 |
| Email Notification Critical | 13 Oct, 2022 | US11484671 |
| Issue Notification Mailed Critical | 12 Oct, 2022 | US11484671 |
| Application Is Considered Ready for Issue Critical | 26 Sep, 2022 | US11484671 |
| Dispatch to FDC | 26 Sep, 2022 | US11484671 |
Tobramycin's Family Patents
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Tobramycin Generic API Manufacturers
Several generic applications have been filed for Tobramycin. The first generic version for Tobramycin was by Sandoz Inc and was approved on Dec 13, 1984. And the latest generic version is by Micro Labs Ltd and was approved on Jul 27, 2023.
Given below is the list of companies who have filed for Tobramycin generic, along with the locations of their manufacturing plants worldwide.
1. ALCON PHARMS LTD
Alcon Pharmaceuticals Ltd has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Alcon Pharms Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.3% | solution/drops | Discontinued | OPHTHALMIC | N/A | May 25, 1994 |
2. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Alembic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.3% | solution/drops | Prescription | OPHTHALMIC | AT | Apr 19, 2019 |
Manufacturing Plant Locations New
Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.
| Country | City | Firm Name | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||||||||
3. ALKEM LABS LTD
Alkem Laboratories Ltd has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 300MG/5ML | solution | Prescription | INHALATION | AN | Apr 1, 2021 |
4. AMNEAL PHARMS
Amneal Pharmaceuticals Of New York Llc has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Amneal Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 300MG/5ML | solution | Prescription | INHALATION | AN | Jul 13, 2015 |
5. APOTEX INC
Apotex Inc has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Apotex Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.3% | solution/drops | Discontinued | OPHTHALMIC | N/A | Feb 25, 2002 |
Manufacturing Plant Locations New
Apotex Inc's manufacturing plants are situated in 1 country - Canada. Given below are the details of these plant locations as well as the firm names of Apotex Inc as present at those locations.
| Country | City | Firm Name | ||||||
|---|---|---|---|---|---|---|---|---|
| Canada |
| |||||||
6. BAUSCH AND LOMB
Bausch And Lomb Pharmaceuticals Inc has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Bausch And Lomb.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.3% | solution/drops | Prescription | OPHTHALMIC | AT | Nov 29, 1993 |
Manufacturing Plant Locations New
Bausch And Lomb's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Bausch And Lomb as present at those locations.
| Country | City | Firm Name | ||||||
|---|---|---|---|---|---|---|---|---|
| United States |
| |||||||
7. CHARTWELL RX
Chartwell Rx Sciences Llc has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Chartwell Rx.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.3% | solution/drops | Prescription | OPHTHALMIC | AT | Sep 11, 2001 |
8. DR REDDYS LABS SA
Dr Reddys Laboratories Sa has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 300MG/5ML | solution | Prescription | INHALATION | AN | Jul 9, 2018 |
9. EPIC PHARMA LLC
Epic Pharma Llc has filed for 1 generic for Tobramycin. This 0.3% version comes by the name AKTOB. Given below are the details of the strengths of this generic introduced by Epic Pharma Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.3% | solution/drops | Discontinued | OPHTHALMIC | N/A | Jan 31, 1996 |
10. GLAND PHARMA LTD
Gland Pharma Ltd has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.3% | solution/drops | Prescription | OPHTHALMIC | AT | Mar 9, 2021 |
11. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 300MG/5ML | solution | Prescription | INHALATION | AN | May 28, 2014 |
Manufacturing Plant Locations New
Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| United States |
| |||||||||
| Portugal |
| |||||||||
| Jordan |
| |||||||||
12. LUOXIN AUROVITAS
Luoxin Aurovitas Pharma Chengdu Co Ltd has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Luoxin Aurovitas.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 300MG/5ML | solution | Discontinued | INHALATION | N/A | Jan 22, 2021 |
13. LUPIN
Lupin Inc has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Lupin.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 300MG/5ML | solution | Prescription | INHALATION | AN | Mar 22, 2017 |
Manufacturing Plant Locations New
Lupin's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Lupin as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||||||||||||||||||||||
| United States |
| |||||||||||||||||||||||||||||
14. MANKIND PHARMA
Mankind Pharma Ltd has filed for 2 different strengths of generic version for Tobramycin. Given below are the details of the strengths of this generic introduced by Mankind Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 300MG/4ML | solution | Prescription | INHALATION | AN | Sep 22, 2022 |
| 300MG/5ML | solution | Prescription | INHALATION | AN | Jun 30, 2023 |
Manufacturing Plant Locations New
Mankind Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Mankind Pharma as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| India |
| |||||
15. MICRO LABS
Micro Labs Ltd has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Micro Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 300MG/5ML | solution | Prescription | INHALATION | AN | Jul 27, 2023 |
Manufacturing Plant Locations New
Micro Labs's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Micro Labs as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||
16. NORVIUM BIOSCIENCE
Norvium Bioscience Llc has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 300MG/5ML | solution | Discontinued | INHALATION | N/A | Oct 13, 2017 |
17. SANDOZ
Sandoz Inc has filed for 1 generic for Tobramycin. This 0.3% version comes by the name TOBREX. Given below are the details of the strengths of this generic introduced by Sandoz.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.3% | solution/drops | Prescription | OPHTHALMIC | AT | Dec 13, 1984 |
Manufacturing Plant Locations New
Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| Austria |
| |||||
| United States |
| |||||
| Spain |
| |||||
| India |
| |||||
18. SOMERSET THERAPS LLC
Somerset Therapeutics Llc has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Somerset Theraps Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.3%
(reference standard) | solution/drops | Prescription | OPHTHALMIC | AT | Jun 28, 2017 |
19. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 1 generic for Tobramycin. Given below are the details of the strengths of this generic introduced by Sun Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 300MG/5ML | solution | Prescription | INHALATION | AN | Dec 26, 2019 |
Manufacturing Plant Locations New
Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
| |||||||||||||||||||||||||||||
| India |
| |||||||||||||||||||||||||||||
20. TEVA PHARMS USA
Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Tobramycin. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 300MG/5ML | solution | Prescription | INHALATION | AN | Oct 10, 2013 |
| 300MG/4ML | solution | Prescription | INHALATION | AN | Jun 26, 2019 |