Cardamyst is a drug owned by Milestone Pharmaceuticals Usa Inc. It is protected by 6 US drug patents filed in 2026 out of which none have expired yet. Cardamyst's patents will be open to challenges from 12 December, 2029. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 15, 2042. Details of Cardamyst'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. | |||
| US10010523 | Short Acting Phenylalkylamine Calcium Channel Blockers And Uses Thereof |
Jun, 2028
(2 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). | |||
| US12257224 | Methods Of Administration For Highly Water-Soluble Salts Of A Short Acting Phenylalkylamine Calcium Channel Blocker |
Jul, 2042
(16 years from now) | Active |
| US10117848 | Highly Water-Soluble Salts Of A Short Acting Phenylalkylamine Calcium Channel Blocker And Uses Thereof |
Apr, 2036
(10 years from now) | Active |
| US10010522 | Short Acting Phenylalkylamine Calcium Channel Blockers And Uses Thereof |
Jun, 2028
(2 years from now) | Active |
| US9227918 | Short Acting Phenylalkylamine Calcium Channel Blockers And Uses Thereof |
Jun, 2028
(2 years from now) | Active |
| US9463179 | Short Acting Phenylalkylamine Calcium Channel Blockers And Uses Thereof |
Jun, 2028
(2 years from now) | Active |
FDA has granted several exclusivities to Cardamyst. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Cardamyst, 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
Cardamyst.
Exclusivity Information
Cardamyst holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Cardamyst's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 12, 2030 |
US patents provide insights into the exclusivity only within the United States, but
Cardamyst 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 Cardamyst's family patents as well as insights into
ongoing legal events
on those patents.
Cardamyst's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cardamyst's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 15, 2042 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cardamyst Generics:
There are no approved generic versions for Cardamyst as of now.
About Cardamyst
Cardamyst is a drug owned by Milestone Pharmaceuticals Usa Inc. Cardamyst uses Etripamil as an active ingredient. Cardamyst was launched by Milestone in 2025.
Approval Date:
Cardamyst was approved by FDA for market use on 12 December, 2025.
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 Cardamyst is 12 December, 2025, its NCE-1 date is estimated to be 12 December, 2029.
Active Ingredient:
Cardamyst uses Etripamil as the active ingredient. Check out other Drugs and Companies using Etripamil ingredient
Dosage:
Cardamyst is available in spray form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 70MG | SPRAY | Prescription | NASAL |