Axid Patent Expiration

Axid is a drug owned by Braintree Laboratories Inc. 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 Jul 17, 2022. Details of Axid'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).
US6930119 Liquid pharmaceutical composition
Jul, 2022

(2 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 Axid's patents.

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

Activity Date Patent Number
Patent litigations
Change in Power of Attorney (May Include Associate POA) 01 Jul, 2021 US6930119
Correspondence Address Change 30 Jun, 2021 US6930119
Change in Power of Attorney (May Include Associate POA) 12 Nov, 2010 US6930119
Correspondence Address Change 09 Nov, 2010 US6930119
Change in Power of Attorney (May Include Associate POA) 12 Sep, 2005 US6930119
Correspondence Address Change 12 Sep, 2005 US6930119
Patent Issue Date Used in PTA Calculation 16 Aug, 2005 US6930119
Recordation of Patent Grant Mailed 16 Aug, 2005 US6930119
Issue Notification Mailed 27 Jul, 2005 US6930119
Receipt into Pubs 20 Jul, 2005 US6930119

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US patents provide insights into the exclusivity only within the United States, but Axid 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 Axid's family patents as well as insights into ongoing legal events on those patents.

Axid's Family Patents

Axid has patent protection in a total of 2 countries. It has a significant patent presence in the US with 80.0% of its patents being US patents. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Axid.

Family Patents

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Generic Launch

Generic Release Date:

Axid's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 17, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Axid Generic API suppliers:

Nizatidine is the generic name for the brand Axid. 9 different companies have already filed for the generic of Axid, with Ani Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Axid's generic

How can I launch a generic of Axid before its drug patent expiration? :

You can seek FDA approval to launch a generic drug before the expiration of Axid's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Axid'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 Axid -

Strength Submission Date ANDA(s) Filed First applicant approval Last patent expiry 180 day status
150 mg and 300 mg
15 mg/mL 14 May, 2008 1 18 Nov, 2009 17 Jul, 2022 Extinguished Eligible





About Axid

Axid is a drug owned by Braintree Laboratories Inc. Axid uses Nizatidine as an active ingredient. Axid was launched by Braintree in 2004.

Approval Date:

Axid was approved by FDA for market use on 25 May, 2004.

Active Ingredient:

Axid uses Nizatidine as the active ingredient. Check out other Drugs and Companies using Nizatidine ingredient

Dosage:

Axid is available in solution form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SOLUTION Discontinued ORAL