Rapiblyk is a drug owned by Aop Orphan Pharmaceuticals Ag. It is protected by 1 US drug patent filed in 2025 out of which none have expired yet. Rapiblyk's patents will be open to challenges from 22 November, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 25, 2034. Details of Rapiblyk's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10722516 | NA |
Apr, 2034
(8 years from now) | Active |
FDA has granted several exclusivities to Rapiblyk. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Rapiblyk, 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
Rapiblyk.
Exclusivity Information
Rapiblyk holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Rapiblyk's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 22, 2029 |
US patents provide insights into the exclusivity only within the United States, but
Rapiblyk 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 Rapiblyk's family patents as well as insights into
ongoing legal events
on those patents.
Rapiblyk's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rapiblyk's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 25, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rapiblyk Generics:
There are no approved generic versions for Rapiblyk as of now.
About Rapiblyk
Rapiblyk is a drug owned by Aop Orphan Pharmaceuticals Ag. Rapiblyk uses Landiolol Hydrochloride as an active ingredient. Rapiblyk was launched by Aop Orphan in 2024.
Approval Date:
Rapiblyk was approved by FDA for market use on 22 November, 2024.
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 Rapiblyk is 22 November, 2024, its NCE-1 date is estimated to be 22 November, 2028.
Active Ingredient:
Rapiblyk uses Landiolol Hydrochloride as the active ingredient. Check out other Drugs and Companies using Landiolol Hydrochloride ingredient
Dosage:
Rapiblyk is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 280MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |