Camzyos is a drug owned by Bristol Myers Squibb Co. It is protected by 3 US drug patents filed from 2022 to 2024 out of which none have expired yet. Camzyos's patents will be open to challenges from 28 April, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 19, 2034. Details of Camzyos'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. | |||
| US9181200 | Pyrimidinedione compounds |
Jun, 2034
(9 years from now) | Active |
| USRE50050 | Pyrimidinedione compounds |
Jun, 2034
(9 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). | |||
| US9585883 | Pyrimidinedione compounds |
Jun, 2034
(9 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 Camzyos's patents.
Latest Legal Activities on Camzyos's Patents
Given below is the list of recent legal activities going on the following patents of Camzyos.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 24 Jun, 2024 | US9585883 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US9585883 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US9181200 |
| Second letter to regulating agency to determine regulatory review period | 30 Sep, 2023 | US9181200 |
| Second letter to regulating agency to determine regulatory review period | 30 Sep, 2023 | US9585883 |
| Letter from FDA or Dept of Agriculture re PTE application | 28 Sep, 2023 | US9181200 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Apr, 2023 | US9181200 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 26 Jan, 2023 | US9181200 |
| Initial letter Re: PTE Application to regulating agency | 08 Jul, 2022 | US9181200 |
| Initial letter Re: PTE Application to regulating agency | 08 Jul, 2022 | US9585883 |
FDA has granted several exclusivities to Camzyos. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Camzyos, 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 Camzyos.
Exclusivity Information
Camzyos holds 3 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Camzyos's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-297) | Jun 15, 2026 |
| New Chemical Entity Exclusivity(NCE) | Apr 28, 2027 |
| Orphan Drug Exclusivity(ODE-398) | Apr 28, 2029 |
US patents provide insights into the exclusivity only within the United States, but Camzyos 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 Camzyos's family patents as well as insights into ongoing legal events on those patents.
Camzyos's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Camzyos's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 19, 2034 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Camzyos Generics:
There are no approved generic versions for Camzyos as of now.
About Camzyos
Camzyos is a drug owned by Bristol Myers Squibb Co. It is used for improving functional capacity and symptoms in adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in NYHA class II-III. Camzyos uses Mavacamten as an active ingredient. Camzyos was launched by Bristol in 2022.
Approval Date:
Camzyos was approved by FDA for market use on 28 April, 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 Camzyos is 28 April, 2022, its NCE-1 date is estimated to be 28 April, 2026.
Active Ingredient:
Camzyos uses Mavacamten as the active ingredient. Check out other Drugs and Companies using Mavacamten ingredient
Treatment:
Camzyos is used for improving functional capacity and symptoms in adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM) in NYHA class II-III.
Dosage:
Camzyos is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 5MG | CAPSULE | Prescription | ORAL |
| 10MG | CAPSULE | Prescription | ORAL |
| 15MG | CAPSULE | Prescription | ORAL |
| 2.5MG | CAPSULE | Prescription | ORAL |