Cobenfy is a drug owned by Bristol-myers Squibb Co. It is protected by 10 US drug patents filed in 2024 out of which none have expired yet. Cobenfy's patents will be open to challenges from 26 September, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 27, 2039. Details of Cobenfy'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). | |||
| US11890378 | Compositions and methods for treating disorders ameliorated by muscarinic receptor activation |
Sep, 2039
(13 years from now) | Active |
| US11471413 | Compositions and methods for treating disorders ameliorated by muscarinic receptor activation |
Sep, 2039
(13 years from now) | Active |
| US11452692 | Compositions and methods for treating disorders ameliorated by muscarinic receptor activation |
Sep, 2039
(13 years from now) | Active |
| US10933020 | Compositions and methods for treating disorders ameliorated by muscarinic receptor activation |
Sep, 2039
(13 years from now) | Active |
| US10925832 | Compositions and methods for treatment of disorders ameliorated by muscarinic receptor activation |
Sep, 2039
(13 years from now) | Active |
| US10369144 | Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation |
Jul, 2030
(4 years from now) | Active |
| US10369143 | Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation |
Jul, 2030
(4 years from now) | Active |
| US10265311 | Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation |
Jul, 2030
(4 years from now) | Active |
| US10238643 | Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation |
Jul, 2030
(4 years from now) | Active |
| US10695339 | Methods and compositions for treatment of disorders ameliorated by muscarinic receptor activation |
Jul, 2030
(4 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 Cobenfy's patents.
Latest Legal Activities on Cobenfy's Patents
Given below is the list of recent legal activities going on the following patents of Cobenfy.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 29 Aug, 2025 | US10369144 |
| Second letter to regulating agency to determine regulatory review period | 29 Aug, 2025 | US10369143 |
| Second letter to regulating agency to determine regulatory review period | 29 Aug, 2025 | US10238643 |
| Letter from FDA or Dept of Agriculture re PTE application | 26 Aug, 2025 | US10238643 |
| Letter from FDA or Dept of Agriculture re PTE application | 26 Aug, 2025 | US10369144 |
| Letter from FDA or Dept of Agriculture re PTE application | 26 Aug, 2025 | US10369143 |
| Mail Patent eCofC Notification | 01 Apr, 2025 | US10933020 |
| Patent eCofC Notification | 01 Apr, 2025 | US10933020 |
| Email Notification | 01 Apr, 2025 | US10933020 |
| Recordation of Patent eCertificate of Correction | 01 Apr, 2025 | US10933020 |
FDA has granted several exclusivities to Cobenfy. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Cobenfy, 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
Cobenfy.
Exclusivity Information
Cobenfy holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Cobenfy's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 26, 2029 |
US patents provide insights into the exclusivity only within the United States, but
Cobenfy 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 Cobenfy's family patents as well as insights into
ongoing legal events
on those patents.
Cobenfy's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cobenfy's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 27, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cobenfy Generics:
There are no approved generic versions for Cobenfy as of now.
Alternative Brands for Cobenfy
There are several other brand drugs in the same treatment category as Cobenfy. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Shandong Luye |
| |||
About Cobenfy
Cobenfy is a drug owned by Bristol-Myers Squibb Co. Cobenfy uses Trospium Chloride; Xanomeline Tartrate as an active ingredient. Cobenfy was launched by Bristol Myers in 2024.
Approval Date:
Cobenfy was approved by FDA for market use on 26 September, 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 Cobenfy is 26 September, 2024, its NCE-1 date is estimated to be 26 September, 2028.
Active Ingredient:
Cobenfy uses Trospium Chloride; Xanomeline Tartrate as the active ingredient. Check out other Drugs and Companies using Trospium Chloride; Xanomeline Tartrate ingredient
Dosage:
Cobenfy is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 30MG;EQ 125MG BASE | CAPSULE | Prescription | ORAL |
| 20MG;EQ 100MG BASE | CAPSULE | Prescription | ORAL |
| 20MG;EQ 50MG BASE | CAPSULE | Prescription | ORAL |