Voquezna Dual Pak is a drug owned by Phathom Pharmaceuticals Inc. It is protected by 2 US drug patents filed in 2022 out of which none have expired yet. Voquezna Dual Pak's patents will be open to challenges from 04 May, 2031. Based on its patents and exclusivities, its generic launch date is estimated to be May 03, 2032. Details of Voquezna Dual Pak'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. | |||
| US7977488 | 1-heterocyclylsulfonyl, 2-aminomethyl, 5-(hetero-) aryl substituted 1-H-pyrrole derivatives as acid secretion inhibitors |
Aug, 2028
(3 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). | |||
| US9186411 | Pharmaceutical composition |
Aug, 2030
(5 years from now) | Active |
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 Voquezna Dual Pak's patents.
Latest Legal Activities on Voquezna Dual Pak's Patents
Given below is the list of recent legal activities going on the following patents of Voquezna Dual Pak.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 01 Mar, 2024 | US7977488 |
| Letter from FDA or Dept of Agriculture re PTE application | 24 Jan, 2024 | US7977488 |
| Initial letter Re: PTE Application to regulating agency | 17 Aug, 2023 | US7977488 |
| Change in Power of Attorney (May Include Associate POA) Critical | 16 Jun, 2023 | US9186411 |
| Email Notification Critical | 16 Jun, 2023 | US9186411 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Apr, 2023 | US9186411 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Dec, 2022 | US7977488 |
| Change in Power of Attorney (May Include Associate POA) Critical | 13 Jul, 2022 | US7977488 |
| Email Notification Critical | 13 Jul, 2022 | US7977488 |
| Correspondence Address Change Critical | 12 Jul, 2022 | US7977488 |
FDA has granted several exclusivities to Voquezna Dual Pak. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Voquezna Dual Pak, 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 Voquezna Dual Pak.
Exclusivity Information
Voquezna Dual Pak holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2032. Details of Voquezna Dual Pak's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 03, 2027 |
| Generating Antibiotic Incentives Now(GAIN) | May 03, 2032 |
US patents provide insights into the exclusivity only within the United States, but Voquezna Dual Pak 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 Voquezna Dual Pak's family patents as well as insights into ongoing legal events on those patents.
Voquezna Dual Pak's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Voquezna Dual Pak's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 03, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Voquezna Dual Pak Generics:
There are no approved generic versions for Voquezna Dual Pak as of now.
About Voquezna Dual Pak
Voquezna Dual Pak is a drug owned by Phathom Pharmaceuticals Inc. Voquezna Dual Pak uses Amoxicillin; Vonoprazan Fumarate as an active ingredient. Voquezna Dual Pak was launched by Phathom in 2022.
Approval Date:
Voquezna Dual Pak was approved by FDA for market use on 03 May, 2022.
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 Voquezna Dual Pak is 03 May, 2022, its NCE-1 date is estimated to be 04 May, 2031.
Active Ingredient:
Voquezna Dual Pak uses Amoxicillin; Vonoprazan Fumarate as the active ingredient. Check out other Drugs and Companies using Amoxicillin; Vonoprazan Fumarate ingredient
Dosage:
Voquezna Dual Pak is available in capsule, tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG;EQ 20MG BASE | CAPSULE, TABLET | Prescription | ORAL |