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 active substance 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.
Latest Legal Activities on Axid's Patents
Given below is the list of recent legal activities going on the following patents of Axid.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 |
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
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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 Generics:
Nizatidine is the generic name for the brand Axid. 8 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.
Market Authorisation 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 |