Tamiflu is a drug owned by Hoffmann La Roche Inc. It is protected by 6 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 02, 2022. Details of Tamiflu'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). | |||
|
US5763483 (Pediatric) | Carbocyclic compounds |
Jun, 2017
(7 years ago) |
Expired
|
| US5763483 | Carbocyclic compounds |
Dec, 2016
(8 years ago) |
Expired
|
|
US5866601 (Pediatric) | Carbocyclic compounds |
Aug, 2016
(8 years ago) |
Expired
|
| US5866601 | Carbocyclic compounds |
Feb, 2016
(8 years ago) |
Expired
|
|
US5952375 (Pediatric) | Compounds and methods for synthesis and therapy |
Aug, 2015
(9 years ago) |
Expired
|
| US5952375 | Compounds and methods for synthesis and therapy |
Feb, 2015
(9 years ago) |
Expired
|
FDA has granted several exclusivities to Tamiflu. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Tamiflu, 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 Tamiflu.
Exclusivity Information
Tamiflu holds 3 exclusivities. All of its exclusivities have expired in 2022. Details of Tamiflu's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-90) | Feb 22, 2013 |
| New Patient Population(NPP) | Dec 21, 2015 |
| M(M-251) | Aug 02, 2022 |
US patents provide insights into the exclusivity only within the United States, but Tamiflu 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 Tamiflu's family patents as well as insights into ongoing legal events on those patents.
Tamiflu's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Tamiflu's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 02, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Tamiflu Generic API suppliers:
Oseltamivir Phosphate is the generic name for the brand Tamiflu. 26 different companies have already filed for the generic of Tamiflu, with Sunshine having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Tamiflu's generic
How can I launch a generic of Tamiflu before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Tamiflu's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Tamiflu'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 Tamiflu -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 30 mg and 45 mg | 02 Aug, 2011 | 1 | 03 Aug, 2016 | 27 Dec, 2016 | Eligible |
| 75 mg | 15 Nov, 2010 | 1 | 03 Aug, 2016 | 27 Dec, 2016 | Eligible |
| 6 mg/mL | 18 Jun, 2015 | 1 | 20 Feb, 2018 | 27 Dec, 2016 | Extinguished |
About Tamiflu
Tamiflu is a drug owned by Hoffmann La Roche Inc. It is used for preventing and treating influenza infections. Tamiflu uses Oseltamivir Phosphate as an active ingredient. Tamiflu was launched by Roche in 2011.
Approval Date:
Tamiflu was approved by FDA for market use on 21 March, 2011.
Active Ingredient:
Tamiflu uses Oseltamivir Phosphate as the active ingredient. Check out other Drugs and Companies using Oseltamivir Phosphate ingredient
Treatment:
Tamiflu is used for preventing and treating influenza infections.
Dosage:
Tamiflu is available in the following dosage forms - for suspension form for oral use, capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 12MG BASE/ML | FOR SUSPENSION | Discontinued | ORAL |
| EQ 30MG BASE | CAPSULE | Prescription | ORAL |
| EQ 75MG BASE | CAPSULE | Prescription | ORAL |
| EQ 6MG BASE/ML | FOR SUSPENSION | Prescription | ORAL |
| EQ 45MG BASE | CAPSULE | Prescription | ORAL |