Zolpimist Patent Expiration

Zolpimist is a drug owned by Aytu Bioscience Inc. It is protected by 2 US drug patents filed from 2013 to 2016. Out of these, 1 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 07, 2032. Details of Zolpimist's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US8236285 Buccal, polar and non-polar spray containing zolpidem
Aug, 2032

(7 years from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7632517 Buccal, polar and non-polar spray containing zolpidem
Oct, 2017

(7 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 Zolpimist's patents.

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

Activity Date Patent Number
Patent litigations
Expire Patent 15 Jan, 2018 US7632517
Expire Patent 02 Sep, 2016 US8236285
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) 09 Apr, 2014 US7632517
Mail-Petition Decision - Accept Late Payment of Maintenance Fees - Granted 09 Apr, 2014 US7632517
Petition Decision - Accept Late Payment of Maintenance Fees - Granted 09 Apr, 2014 US7632517
Petition to Accept Late Payment of Maintenance Fee Payment Filed 09 Apr, 2014 US7632517
Expire Patent 10 Jan, 2014 US7632517
Patent Issue Date Used in PTA Calculation 07 Aug, 2012 US8236285
Recordation of Patent Grant Mailed 07 Aug, 2012 US8236285
Issue Notification Mailed 18 Jul, 2012 US8236285

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

Zolpimist's Family Patents

Zolpimist has patent protection in a total of 9 countries. It has a significant patent presence in the US with 53.3% of its patents being US patents. 5 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Zolpimist.

Family Patents

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Generic Launch

Generic Release Date:

Zolpimist's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 07, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Zolpimist Generic API suppliers:

Zolpidem Tartrate is the generic name for the brand Zolpimist. 30 different companies have already filed for the generic of Zolpimist, with Endo Operations having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Zolpimist's generic

Alternative Brands for Zolpimist

Zolpimist which is used for treating symptoms of transient insomnia., has several other brand drugs using the same active ingredient (Zolpidem Tartrate). 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
Mylan Speciality Lp
Edluar
Purdue Pharma
Intermezzo
Sanofi Aventis Us
Ambien Cr


Apart from brand drugs containing the same ingredient, some generics have also been filed for Zolpidem Tartrate, Zolpimist's active ingredient. Check the complete list of approved generic manufacturers for Zolpimist





About Zolpimist

Zolpimist is a drug owned by Aytu Bioscience Inc. It is used for treating symptoms of transient insomnia. Zolpimist uses Zolpidem Tartrate as an active ingredient. Zolpimist was launched by Aytu in 2008.

Approval Date:

Zolpimist was approved by FDA for market use on 19 December, 2008.

Active Ingredient:

Zolpimist uses Zolpidem Tartrate as the active ingredient. Check out other Drugs and Companies using Zolpidem Tartrate ingredient

Treatment:

Zolpimist is used for treating symptoms of transient insomnia.

Dosage:

Zolpimist is available in spray, metered form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
5MG/SPRAY SPRAY, METERED Discontinued ORAL