Tobi is a drug owned by Mylan Specialty Lp. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 19, 2014. Details of Tobi'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). | |||
| US5508269 | Aminoglycoside formulation for aerosolization |
Oct, 2014
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Tobi 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's family patents as well as insights into ongoing legal events on those patents.
Tobi's Family Patents
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Generic Launch
Generic Release Date:
Tobi's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 19, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tobi Generic API suppliers:
Tobramycin is the generic name for the brand Tobi. 20 different companies have already filed for the generic of Tobi, with Mankind Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tobi's generic
How can I launch a generic of Tobi before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tobi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tobi's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Tobi -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 300 mg/5 mL | 29 Jun, 2009 | 1 | 10 Oct, 2013 | 19 Oct, 2014 | Extinguished |
Alternative Brands for Tobi
Tobi 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's active ingredient. Check the complete list of approved generic manufacturers for Tobi
About Tobi
Tobi is a drug owned by Mylan Specialty Lp. It is used for treating cystic fibrosis patients infected with Pseudomonas aeruginosa. Tobi uses Tobramycin as an active ingredient. Tobi was launched by Mylan Speciality Lp in 1997.
Approval Date:
Tobi was approved by FDA for market use on 22 December, 1997.
Active Ingredient:
Tobi uses Tobramycin as the active ingredient. Check out other Drugs and Companies using Tobramycin ingredient
Treatment:
Tobi is used for treating cystic fibrosis patients infected with Pseudomonas aeruginosa.
Dosage:
Tobi is available in solution form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300MG/5ML | SOLUTION | Prescription | INHALATION |