Paxlovid (copackaged) is a drug owned by Pfizer Inc. It is protected by 2 US drug patents filed in 2023 out of which none have expired yet. Paxlovid (Copackaged)'s patents will be open to challenges from 26 May, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 31, 2041. Details of Paxlovid (copackaged)'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. | |||
| US11351149 | Nitrile-containing antiviral compounds |
Aug, 2041
(16 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). | |||
| US11541034 | Nitrile-containing antiviral compounds |
Oct, 2041
(16 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 Paxlovid (copackaged)'s patents.
Latest Legal Activities on Paxlovid (copackaged)'s Patents
Given below is the list of recent legal activities going on the following patents of Paxlovid (copackaged).
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Information Disclosure Statement (IDS) Filed Critical | 04 Apr, 2024 | US11351149 |
| Sequence Moved to Public Database | 04 Jan, 2023 | US11541034 |
| Recordation of Patent Grant Mailed Critical | 03 Jan, 2023 | US11541034 |
| Patent Issue Date Used in PTA Calculation Critical | 03 Jan, 2023 | US11541034 |
| Email Notification Critical | 15 Dec, 2022 | US11541034 |
| Issue Notification Mailed Critical | 14 Dec, 2022 | US11541034 |
| Application Is Considered Ready for Issue Critical | 30 Nov, 2022 | US11541034 |
| Dispatch to FDC | 30 Nov, 2022 | US11541034 |
| Printer Rush- No mailing | 21 Nov, 2022 | US11541034 |
| Pubs Case Remand to TC Critical | 10 Nov, 2022 | US11541034 |
FDA has granted several exclusivities to Paxlovid (copackaged). Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Paxlovid (copackaged), 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 Paxlovid (copackaged).
Exclusivity Information
Paxlovid (copackaged) holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Paxlovid (copackaged)'s exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | May 25, 2028 |
US patents provide insights into the exclusivity only within the United States, but Paxlovid (copackaged) 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 Paxlovid (copackaged)'s family patents as well as insights into ongoing legal events on those patents.
Paxlovid (copackaged)'s Family Patents
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Generic Launch
Generic Release Date:
Paxlovid (copackaged)'s generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 31, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Paxlovid (copackaged) Generics:
There are no approved generic versions for Paxlovid (copackaged) as of now.
About Paxlovid (copackaged)
Paxlovid (Copackaged) is a drug owned by Pfizer Inc. It is used for treating mild-to-moderate COVID-19 in high-risk adults to prevent progression to severe outcomes like hospitalization or death. Paxlovid (Copackaged) uses Nirmatrelvir; Ritonavir as an active ingredient. Paxlovid (Copackaged) was launched by Pfizer in 2023.
Approval Date:
Paxlovid (copackaged) was approved by FDA for market use on 25 May, 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 Paxlovid (copackaged) is 25 May, 2023, its NCE-1 date is estimated to be 26 May, 2027.
Active Ingredient:
Paxlovid (copackaged) uses Nirmatrelvir; Ritonavir as the active ingredient. Check out other Drugs and Companies using Nirmatrelvir; Ritonavir ingredient
Treatment:
Paxlovid (copackaged) is used for treating mild-to-moderate COVID-19 in high-risk adults to prevent progression to severe outcomes like hospitalization or death.
Dosage:
Paxlovid (copackaged) is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG;100MG | TABLET | Prescription | ORAL |