Taxotere is a drug owned by Sanofi Aventis Us Llc. It is protected by 8 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 May 22, 2014. Details of Taxotere'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). | |||
|
US5438072 (Pediatric) | Taxoid-based compositions |
May, 2014
(10 years ago) |
Expired
|
| US5438072 | Taxoid-based compositions |
Nov, 2013
(11 years ago) |
Expired
|
|
US5698582 (Pediatric) | Compositions containing taxane derivatives |
Jan, 2013
(11 years ago) |
Expired
|
|
US5714512 (Pediatric) | Compositions containing taxane derivatives |
Jan, 2013
(11 years ago) |
Expired
|
|
US5750561 (Pediatric) | Compositions containing taxane derivatives |
Jan, 2013
(11 years ago) |
Expired
|
| US5714512 | Compositions containing taxane derivatives |
Jul, 2012
(12 years ago) |
Expired
|
| US5698582 | Compositions containing taxane derivatives |
Jul, 2012
(12 years ago) |
Expired
|
| US5750561 | Compositions containing taxane derivatives |
Jul, 2012
(12 years ago) |
Expired
|
FDA has granted several exclusivities to Taxotere. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Taxotere, 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 Taxotere.
Exclusivity Information
Taxotere holds 2 exclusivities. All of its exclusivities have expired in 2013. Details of Taxotere's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-61) | May 13, 2013 |
| Pediatric Exclusivity(PED) | Nov 13, 2013 |
US patents provide insights into the exclusivity only within the United States, but Taxotere 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 Taxotere's family patents as well as insights into ongoing legal events on those patents.
Taxotere's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Taxotere's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 22, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Taxotere Generic API suppliers:
Docetaxel is the generic name for the brand Taxotere. 15 different companies have already filed for the generic of Taxotere, with Hengrui Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Taxotere's generic
How can I launch a generic of Taxotere before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Taxotere's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Taxotere'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 Taxotere -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg/mL, 0.5 mL and 2 mL vials | 30 Jun, 2009 | 1 | 22 Nov, 2013 | Extinguished |
Alternative Brands for Taxotere
Taxotere which is used for treating hypertension and congestive heart failure., has several other brand drugs using the same active ingredient (Docetaxel). 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.
Apart from brand drugs containing the same ingredient, some generics have also been filed for Docetaxel, Taxotere's active ingredient. Check the complete list of approved generic manufacturers for Taxotere
About Taxotere
Taxotere is a drug owned by Sanofi Aventis Us Llc. It is used for treating hypertension and congestive heart failure. Taxotere uses Docetaxel as an active ingredient. Taxotere was launched by Sanofi Aventis Us in 2010.
Approval Date:
Taxotere was approved by FDA for market use on 03 August, 2010.
Active Ingredient:
Taxotere uses Docetaxel as the active ingredient. Check out other Drugs and Companies using Docetaxel ingredient
Treatment:
Taxotere is used for treating hypertension and congestive heart failure.
Dosage:
Taxotere is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE | Discontinued | INJECTION |
| 20MG/ML (20MG/ML) | INJECTABLE | Prescription | INJECTION |
| 80MG/4ML (20MG/ML) | INJECTABLE | Prescription | INJECTION |