Zavzpret is a drug owned by Pfizer Inc. It is protected by 3 US drug patents filed in 2023. Out of these, 1 drug patents are active and 2 have expired. Zavzpret's patents will be open to challenges from 10 March, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 07, 2031. Details of Zavzpret'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. | |||
| US8481546 | CGRP receptor antagonist |
Oct, 2031
(6 years from now) | Active |
| US7220862 | Calcitonin gene related peptide receptor antagonists |
Jan, 2024
(10 months ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7314883 | Anti-migraine treatments |
Dec, 2023
(11 months 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 Zavzpret's patents.
Latest Legal Activities on Zavzpret's Patents
Given below is the list of recent legal activities going on the following patents of Zavzpret.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 08 Feb, 2024 | US8481546 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US8481546 |
| Letter re PTE application to FDA or Dept of Agriculture | 16 May, 2023 | US8481546 |
| Patent Term Extension Application under 35 USC 156 Filed | 03 May, 2023 | US8481546 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Dec, 2020 | US8481546 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Jun, 2019 | US7314883 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Nov, 2018 | US7220862 |
| Patent Issue Date Used in PTA Calculation Critical | 09 Jul, 2013 | US8481546 |
| Recordation of Patent Grant Mailed Critical | 09 Jul, 2013 | US8481546 |
| Email Notification Critical | 20 Jun, 2013 | US8481546 |
FDA has granted several exclusivities to Zavzpret. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zavzpret, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Zavzpret.
Exclusivity Information
Zavzpret holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Zavzpret's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Mar 09, 2028 |
US patents provide insights into the exclusivity only within the United States, but Zavzpret 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 Zavzpret's family patents as well as insights into ongoing legal events on those patents.
Zavzpret's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zavzpret's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 07, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Zavzpret Generics:
There are no approved generic versions for Zavzpret as of now.
About Zavzpret
Zavzpret is a drug owned by Pfizer Inc. It is used for acute treatment of migraine with or without aura. Zavzpret uses Zavegepant Hydrochloride as an active ingredient. Zavzpret was launched by Pfizer in 2023.
Approval Date:
Zavzpret was approved by FDA for market use on 09 March, 2023.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Zavzpret is 09 March, 2023, its NCE-1 date is estimated to be 10 March, 2027.
Active Ingredient:
Zavzpret uses Zavegepant Hydrochloride as the active ingredient. Check out other Drugs and Companies using Zavegepant Hydrochloride ingredient
Treatment:
Zavzpret is used for acute treatment of migraine with or without aura.
Dosage:
Zavzpret is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 10MG BASE/SPRAY | SPRAY, METERED | Prescription | NASAL |