Cosela is a drug owned by Pharmacosmos As. It is protected by 13 US drug patents filed from 2021 to 2025 out of which none have expired yet. Cosela's patents have been open to challenges since 12 February, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 13, 2040. Details of Cosela'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. | |||
| US12168666 | Morphic forms of trilaciclib and methods of manufacture thereof |
Nov, 2040
(15 years from now) | Active |
| US8598197 | CDK inhibitors |
Oct, 2031
(6 years from now) | Active |
| US10189849 | CDK inhibitors |
Oct, 2031
(6 years from now) | Active |
| US8598186 | CDK inhibitors |
Oct, 2031
(6 years from now) | Active |
| US9957276 | CDK inhibitors |
Oct, 2031
(6 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). | |||
| US11529352 | Preservation of immune response during chemotherapy regimens |
Jul, 2039
(14 years from now) | Active |
| US10966984 | Transient protection of normal cells during chemotherapy |
Mar, 2034
(8 years from now) | Active |
| US9487530 | Transient protection of normal cells during chemotherapy |
Mar, 2034
(8 years from now) | Active |
| US10085992 | Transient protection of normal cells during chemotherapy |
Mar, 2034
(8 years from now) | Active |
| US11717523 | Transient protection of normal cells during chemotherapy |
Mar, 2034
(8 years from now) | Active |
| US11040042 | Transient protection of normal cells during chemotherapy |
Oct, 2031
(6 years from now) | Active |
| US10189850 | CDK inhibitors |
Oct, 2031
(6 years from now) | Active |
| US10927120 | CDK inhibitors |
Oct, 2031
(6 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 Cosela's patents.
Latest Legal Activities on Cosela's Patents
Given below is the list of recent legal activities going on the following patents of Cosela.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 24 Apr, 2024 | US9487530 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US8598186 |
| transaction for FDA Determination of Regulatory Review Period | 30 Jan, 2024 | US9487530 |
| transaction for FDA Determination of Regulatory Review Period | 28 Nov, 2023 | US8598186 |
| transaction for FDA Determination of Regulatory Review Period | 28 Nov, 2023 | US9487530 |
| Patent eGrant Notification | 08 Aug, 2023 | US11717523 |
| Mail Patent eGrant Notification | 08 Aug, 2023 | US11717523 |
| Patent Issue Date Used in PTA Calculation Critical | 08 Aug, 2023 | US11717523 |
| Recordation of Patent eGrant | 08 Aug, 2023 | US11717523 |
| Recordation of Patent Grant Mailed Critical | 08 Aug, 2023 | US11717523 |
FDA has granted several exclusivities to Cosela. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cosela, 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 Cosela.
Exclusivity Information
Cosela holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Cosela's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 12, 2026 |
US patents provide insights into the exclusivity only within the United States, but Cosela 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 Cosela's family patents as well as insights into ongoing legal events on those patents.
Cosela's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cosela's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 13, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cosela Generics:
There are no approved generic versions for Cosela as of now.
About Cosela
Cosela is a drug owned by Pharmacosmos As. It is used for reducing chemotherapy-induced myelosuppression in adult patients receiving specific regimens for extensive-stage small cell lung cancer. Cosela uses Trilaciclib Dihydrochloride as an active ingredient. Cosela was launched by Pharmacosmos in 2021.
Approval Date:
Cosela was approved by FDA for market use on 12 February, 2021.
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 Cosela is 12 February, 2021, its NCE-1 date is estimated to be 12 February, 2025.
Active Ingredient:
Cosela uses Trilaciclib Dihydrochloride as the active ingredient. Check out other Drugs and Companies using Trilaciclib Dihydrochloride ingredient
Treatment:
Cosela is used for reducing chemotherapy-induced myelosuppression in adult patients receiving specific regimens for extensive-stage small cell lung cancer.
Dosage:
Cosela is available in powder form for intravenous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 300MG BASE/VIAL | POWDER | Prescription | INTRAVENOUS |