Allegra Patent Expiration

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.

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

Activity Date Patent Number
Patent litigations
Expire Patent 17 Dec, 2018 US7135571
Maintenance Fee Reminder Mailed 25 Jun, 2018 US7135571
Expire Patent 19 Dec, 2014 US7138524
Petition Decision - Granted 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 21 Nov, 2006 US7138524
Recordation of Patent Grant Mailed 21 Nov, 2006 US7138524
Patent Issue Date Used in PTA Calculation 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.

Last updated on December 3, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US6037353 November, 1999 Decision
(02 Nov, 1999)
YOUNG

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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


Family Patents

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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
Allegra-d 12 Hour Allergy And Congestion

(uses Fexofenadine Hydrochloride)

Used for treating allergic rhinitis, respiratory allergies, nasal swelling, sinus congestion, and pressure in adults and children aged 12 and older.
Merck Sharp Dohme
Clarinex used for treating symptoms of allergic rhinitis and chronic idiopathic urticaria.
Organon
Clarinex used for treating symptoms of allergic rhinitis and chronic idiopathic urticaria.
Clarinex D 24 Hour Used for relieving both nasal and non-nasal symptoms of seasonal allergic rhinitis.
Organon Llc
Clarinex-d 12 Hour Used for managing symptoms of allergic rhinitis.

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.



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