Tobi Podhaler is a drug owned by Mylan Specialty Lp. It is protected by 14 US drug patents filed from 2013 to 2022. Out of these, 4 drug patents are active and 10 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 04, 2030. Details of Tobi Podhaler's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10207066 | Aerosolization apparatus with capsule puncture alignment guide |
Nov, 2030
(5 years from now) | Active |
| US8869794 | Aerosolization apparatus with capsule puncturing member |
Sep, 2028
(3 years from now) | Active |
| US7559325 | Aerosolization apparatus with air inlet shield |
Oct, 2025
(11 months from now) | Active |
| US8664187 | Methods of treatment of endobronchial infections |
Jun, 2025
(7 months from now) | Active |
| US11484671 | Aerosolization apparatus with capsule puncture alignment guide |
Nov, 2024
(8 days ago) |
Expired
|
| US8069851 | Aeorosolization apparatus with air inlet shield |
Sep, 2024
(a month ago) |
Expired
|
| USRE47526 | Aerosolization apparatus with air inlet shield |
Apr, 2024
(7 months ago) |
Expired
|
| US7516741 | Aerosolization apparatus with feedback mechanism |
Jan, 2024
(10 months ago) |
Expired
|
| US7368102 | Pulmonary delivery of aminoglycosides |
Dec, 2022
(1 year, 10 months ago) |
Expired
|
| US8715623 | Pulmonary delivery of aminoglycoside |
Dec, 2022
(1 year, 10 months ago) |
Expired
|
| US9421166 | Pulmonary delivery of aminoglycoside |
Dec, 2022
(1 year, 10 months ago) |
Expired
|
| US7097827 | Devices, compositions and methods for the pulmonary delivery of aerosolized medicaments |
Jun, 2021
(3 years ago) |
Expired
|
| US7442388 | Phospholipid-based powders for drug delivery |
May, 2020
(4 years ago) |
Expired
|
| US8349294 | Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use |
May, 2020
(4 years ago) |
Expired
|
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 Tobi Podhaler's patents.
Latest Legal Activities on Tobi Podhaler's Patents
Given below is the list of recent legal activities going on the following patents of Tobi Podhaler.
| 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 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Tobi Podhaler and ongoing litigations to help you estimate the early arrival of Tobi Podhaler generic.
Tobi Podhaler's Litigations
Tobi Podhaler been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on May 27, 2009, against patent number US10207066. The petitioner , challenged the validity of this patent, with Michael John Dunkley et al as the respondent. Click below to track the latest information on how companies are challenging Tobi Podhaler's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US10207066 | October, 2016 |
Decision
(18 Sep, 2018) | Michael John Dunkley et al | |
| US10207066 | May, 2009 |
Decision
(23 Dec, 2011) | Michael John Dunkley et al | |
FDA has granted some exclusivities to Tobi Podhaler. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tobi Podhaler, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Tobi Podhaler.
Exclusivity Information
Tobi Podhaler holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Tobi Podhaler's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Mar 22, 2016 |
Several oppositions have been filed on Tobi Podhaler's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Tobi Podhaler's generic, the next section provides detailed information on ongoing and past EP oppositions related to Tobi Podhaler patents.
Tobi Podhaler's Oppositions Filed in EPO
Tobi Podhaler has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 12, 2012, by Norton Healthcare Limited. This opposition was filed on patent number EP04759324A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP04759324A | Dec, 2012 | NORTON HEALTHCARE LIMITED | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Tobi Podhaler is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Tobi Podhaler's family patents as well as insights into ongoing legal events on those patents.
Tobi Podhaler's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tobi Podhaler's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 04, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tobi Podhaler Generic API suppliers:
Tobramycin is the generic name for the brand Tobi Podhaler. 20 different companies have already filed for the generic of Tobi Podhaler, with Mankind Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tobi Podhaler's generic
Alternative Brands for Tobi Podhaler
Tobi Podhaler which is used for treating cystic fibrosis patients infected with Pseudomonas aeruginosa., has several other brand drugs in the same treatment category and using the same active ingredient (Tobramycin). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Mylan Speciality Lp |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Tobramycin. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Bausch And Lomb |
| |
| Chiesi |
| |
| Harrow Eye |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Tobramycin, Tobi Podhaler's active ingredient. Check the complete list of approved generic manufacturers for Tobi Podhaler
About Tobi Podhaler
Tobi Podhaler is a drug owned by Mylan Specialty Lp. It is used for treating cystic fibrosis patients infected with Pseudomonas aeruginosa. Tobi Podhaler uses Tobramycin as an active ingredient. Tobi Podhaler was launched by Mylan Speciality Lp in 2013.
Approval Date:
Tobi Podhaler was approved by FDA for market use on 22 March, 2013.
Active Ingredient:
Tobi Podhaler uses Tobramycin as the active ingredient. Check out other Drugs and Companies using Tobramycin ingredient
Treatment:
Tobi Podhaler is used for treating cystic fibrosis patients infected with Pseudomonas aeruginosa.
Dosage:
Tobi Podhaler is available in powder form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 28MG | POWDER | Prescription | INHALATION |