Rapivab is a drug owned by Biocryst Pharmaceuticals Inc. It is protected by 4 US drug patents filed from 2014 to 2019. Out of these, 2 drug patents are active and 2 have expired. Rapivab's patents have been open to challenges since 19 December, 2018. Based on its patents and exclusivities, its generic launch date is estimated to be May 07, 2027. Details of Rapivab'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. | |||
| US6562861 | Substituted cyclopentane and cyclopentene compounds useful as neuraminidase inhibitors |
Dec, 2023
(1 year, 6 months ago) |
Expired
|
| US6503745 | Cyclopentane and cyclopentene compounds and use for detecting influenza virus |
Nov, 2019
(5 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8778997 | Antiviral treatments |
May, 2027
(1 year, 10 months from now) | Active |
| US10391075 | Antiviral treatments |
Feb, 2027
(1 year, 7 months 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 Rapivab's patents.
Latest Legal Activities on Rapivab's Patents
Given below is the list of recent legal activities going on the following patents of Rapivab.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Feb, 2023 | US10391075 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Dec, 2021 | US8778997 |
| Recordation of Patent Grant Mailed Critical | 27 Aug, 2019 | US10391075 |
| Patent Issue Date Used in PTA Calculation Critical | 27 Aug, 2019 | US10391075 |
| Email Notification Critical | 08 Aug, 2019 | US10391075 |
| Issue Notification Mailed Critical | 07 Aug, 2019 | US10391075 |
| Dispatch to FDC | 29 Jul, 2019 | US10391075 |
| Application Is Considered Ready for Issue Critical | 19 Jul, 2019 | US10391075 |
| Issue Fee Payment Verified Critical | 12 Jul, 2019 | US10391075 |
| Issue Fee Payment Received Critical | 12 Jul, 2019 | US10391075 |
FDA has granted several exclusivities to Rapivab. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rapivab, 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 Rapivab.
Exclusivity Information
Rapivab holds 2 exclusivities. All of its exclusivities have expired in 2020. Details of Rapivab's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 19, 2019 |
| New Patient Population(NPP) | Sep 20, 2020 |
US patents provide insights into the exclusivity only within the United States, but Rapivab 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 Rapivab's family patents as well as insights into ongoing legal events on those patents.
Rapivab's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rapivab's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 07, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rapivab Generics:
There are no approved generic versions for Rapivab as of now.
About Rapivab
Rapivab is a drug owned by Biocryst Pharmaceuticals Inc. It is used for treating acute uncomplicated influenza in patients 6 months and older. Rapivab uses Peramivir as an active ingredient. Rapivab was launched by Biocryst in 2014.
Approval Date:
Rapivab was approved by FDA for market use on 19 December, 2014.
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 Rapivab is 19 December, 2014, its NCE-1 date is estimated to be 19 December, 2018.
Active Ingredient:
Rapivab uses Peramivir as the active ingredient. Check out other Drugs and Companies using Peramivir ingredient
Treatment:
Rapivab is used for treating acute uncomplicated influenza in patients 6 months and older.
Dosage:
Rapivab is available in solution form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG/20ML (10MG/ML) | SOLUTION | Prescription | INTRAVENOUS |