Tobi Podhaler Patent Expiration

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

(6 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.

Given below is the list of recent legal activities going on the following patents of Tobi Podhaler.

Activity Date Patent Number
Patent litigations
Court Processing Terminated 17 Apr, 2024 US7516741
Maintenance Fee Reminder Mailed 15 Apr, 2024 US9421166
Court Processing Terminated 01 Mar, 2024 US7097827
Court Processing Terminated 28 Feb, 2024 US7442388
Recordation of Patent Grant Mailed 01 Nov, 2022 US11484671
Patent Issue Date Used in PTA Calculation 01 Nov, 2022 US11484671
Email Notification 13 Oct, 2022 US11484671
Issue Notification Mailed 12 Oct, 2022 US11484671
Application Is Considered Ready for Issue 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.

Last updated on November 12, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
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

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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
Patent litigations
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

Tobi Podhaler has patent protection in a total of 28 countries. It's US patent count contributes only to 26.7% of its total global patent coverage. 5 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Tobi Podhaler.

Family Patents

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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
Tobi

(uses Tobramycin)

Used for treating cystic fibrosis patients infected with Pseudomonas aeruginosa.

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
Zylet
Chiesi
Bethkis
Harrow Eye
Tobradex St


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