Allegra is a drug owned by Chattem Inc Dba Sanofi Consumer Healthcare. It is protected by 18 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 Sep 14, 2017. Details of Allegra'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). | |||
|
US6037353 (Pediatric) | Method of providing an antihistaminic effect in a hepatically impaired patient |
Sep, 2017
(7 years ago) |
Expired
|
| US6037353 | Method of providing an antihistaminic effect in a hepatically impaired patient |
Mar, 2017
(7 years ago) |
Expired
|
|
US5738872 (Pediatric) | Pharmaceutical composition for piperidinoalkanol compounds |
Aug, 2015
(9 years ago) |
Expired
|
|
US5932247 (Pediatric) | Pharmaceutical composition for piperidinoalkanol compounds |
Aug, 2015
(9 years ago) |
Expired
|
|
US5855912 (Pediatric) | Pharmaceutical compositions for piperidinalkanol compounds |
Aug, 2015
(9 years ago) |
Expired
|
|
US6113942 (Pediatric) | Pharmaceutical composition for piperidinoalkanol compounds |
Aug, 2015
(9 years ago) |
Expired
|
| US5738872 | Pharmaceutical composition for piperidinoalkanol compounds |
Feb, 2015
(9 years ago) |
Expired
|
| US6113942 | Pharmaceutical composition for piperidinoalkanol compounds |
Feb, 2015
(9 years ago) |
Expired
|
| US5932247 | Pharmaceutical composition for piperidinoalkanol compounds |
Feb, 2015
(9 years ago) |
Expired
|
| US5855912 | Pharmaceutical compositions for piperidinalkanol compounds |
Feb, 2015
(9 years ago) |
Expired
|
|
US7138524 (Pediatric) | Processes for preparing anhydrous and hydrate forms of antihistaminic piperidine derivatives, polymorphs and pseudomorphs thereof |
Nov, 2014
(10 years ago) |
Expired
|
|
US7135571 (Pediatric) | Processes for preparing anhydrous and hydrate forms of antihistaminic piperidine derivatives, polymorphs and pseudomorphs thereof |
Nov, 2014
(10 years ago) |
Expired
|
|
US5578610 (Pediatric) | Piperidine derivatives |
May, 2014
(10 years ago) |
Expired
|
| US7138524 | Processes for preparing anhydrous and hydrate forms of antihistaminic piperidine derivatives, polymorphs and pseudomorphs thereof |
May, 2014
(10 years ago) |
Expired
|
| US7135571 | Processes for preparing anhydrous and hydrate forms of antihistaminic piperidine derivatives, polymorphs and pseudomorphs thereof |
May, 2014
(10 years ago) |
Expired
|
| US5578610 | Piperidine derivatives |
Nov, 2013
(11 years ago) |
Expired
|
|
US6187791 (Pediatric) | Method of providing an antihistaminic effect in a hepatically impaired patient |
Nov, 2012
(12 years ago) |
Expired
|
|
US6399632 (Pediatric) | Method of providing an antihistaminic effect in a hepatically impaired patient |
Nov, 2012
(12 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 Allegra's patents.
Latest Legal Activities on Allegra's Patents
Given below is the list of recent legal activities going on the following patents of Allegra.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 17 Dec, 2018 | US7135571 |
| Maintenance Fee Reminder Mailed Critical | 25 Jun, 2018 | US7135571 |
| Expire Patent Critical | 19 Dec, 2014 | US7138524 |
| Petition Decision - Granted Critical | 31 Jan, 2008 | US7135571 |
| Mail-Petition Decision - Granted | 31 Jan, 2008 | US7135571 |
| Petition Entered | 14 Jan, 2008 | US7135571 |
| Post Issue Communication - Certificate of Correction | 05 Jan, 2007 | US7135571 |
| Patent Issue Date Used in PTA Calculation Critical | 21 Nov, 2006 | US7138524 |
| Recordation of Patent Grant Mailed Critical | 21 Nov, 2006 | US7138524 |
| Patent Issue Date Used in PTA Calculation Critical | 14 Nov, 2006 | US7135571 |
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 Allegra and ongoing litigations to help you estimate the early arrival of Allegra generic.
Allegra's Litigations
Allegra been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 02, 1999, against patent number US6037353. The petitioner , challenged the validity of this patent, with YOUNG as the respondent. Click below to track the latest information on how companies are challenging Allegra's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US6037353 | November, 1999 |
Decision
(02 Nov, 1999) | YOUNG | |
US patents provide insights into the exclusivity only within the United States, but Allegra 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 Allegra's family patents as well as insights into ongoing legal events on those patents.
Allegra's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Allegra's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 14, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Allegra Generic API suppliers:
Fexofenadine Hydrochloride is the generic name for the brand Allegra. 14 different companies have already filed for the generic of Allegra, with Dr Reddys Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Allegra's generic
How can I launch a generic of Allegra before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Allegra's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Allegra'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 Allegra -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 60 mg |
Alternative Brands for Allegra
Allegra which is used for treating allergic rhinitis and skin manifestations of chronic idiopathic urticaria in children., has several other brand drugs in the same treatment category and using the same active ingredient (Fexofenadine Hydrochloride). 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 | ||||
|---|---|---|---|---|---|---|
| Chattem Sanofi |
| |||||
| Merck Sharp Dohme |
| |||||
| Organon |
| |||||
| Organon Llc |
| |||||
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. Fexofenadine Hydrochloride. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |||||
|---|---|---|---|---|---|---|
| Chattem Sanofi |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Fexofenadine Hydrochloride, Allegra's active ingredient. Check the complete list of approved generic manufacturers for Allegra
About Allegra
Allegra is a drug owned by Chattem Inc Dba Sanofi Consumer Healthcare. It is used for treating allergic rhinitis and skin manifestations of chronic idiopathic urticaria in children. Allegra uses Fexofenadine Hydrochloride as an active ingredient. Allegra was launched by Chattem Sanofi in 1996.
Approval Date:
Allegra was approved by FDA for market use on 25 July, 1996.
Active Ingredient:
Allegra uses Fexofenadine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Fexofenadine Hydrochloride ingredient
Treatment:
Allegra is used for treating allergic rhinitis and skin manifestations of chronic idiopathic urticaria in children.
Dosage:
Allegra is available in the following dosage forms - capsule form for oral use, suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE | Discontinued | ORAL |
| 30MG/5ML | SUSPENSION | Discontinued | ORAL |