Cibinqo is a drug owned by Pfizer Inc. It is protected by 3 US drug patents filed in 2022 out of which none have expired yet. Cibinqo's patents will be open to challenges from 14 January, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 19, 2034. Details of Cibinqo'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. | |||
| US9035074 | Pyrrolo[2,3-D]pyrimidine derivatives |
Feb, 2034
(8 years from now) | Active |
| US9545405 | Pyrrolo[2,3-D]pyrimidine derivatives |
Feb, 2034
(8 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). | |||
| US9549929 | Pyrrolo[2,3-D]pyrimidine derivatives |
Feb, 2034
(8 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 Cibinqo's patents.
Latest Legal Activities on Cibinqo's Patents
Given below is the list of recent legal activities going on the following patents of Cibinqo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Jun, 2024 | US9545405 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Jun, 2024 | US9549929 |
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US9545405 |
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US9035074 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US9545405 |
| transaction for FDA Determination of Regulatory Review Period | 29 Feb, 2024 | US9035074 |
| Second letter to regulating agency to determine regulatory review period | 30 Sep, 2023 | US9035074 |
| Second letter to regulating agency to determine regulatory review period | 30 Sep, 2023 | US9545405 |
| Letter from FDA or Dept of Agriculture re PTE application | 28 Sep, 2023 | US9545405 |
| Letter from FDA or Dept of Agriculture re PTE application | 28 Sep, 2023 | US9035074 |
FDA has granted several exclusivities to Cibinqo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cibinqo, 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 Cibinqo.
Exclusivity Information
Cibinqo holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Cibinqo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Feb 09, 2026 |
| New Chemical Entity Exclusivity(NCE) | Jan 14, 2027 |
US patents provide insights into the exclusivity only within the United States, but Cibinqo 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 Cibinqo's family patents as well as insights into ongoing legal events on those patents.
Cibinqo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cibinqo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 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)
Cibinqo Generics:
There are no approved generic versions for Cibinqo as of now.
About Cibinqo
Cibinqo is a drug owned by Pfizer Inc. It is used for treating adults with refractory, moderate-to-severe atopic dermatitis not adequately controlled with other systemic drug products. Cibinqo uses Abrocitinib as an active ingredient. Cibinqo was launched by Pfizer in 2022.
Approval Date:
Cibinqo was approved by FDA for market use on 14 January, 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 Cibinqo is 14 January, 2022, its NCE-1 date is estimated to be 14 January, 2026.
Active Ingredient:
Cibinqo uses Abrocitinib as the active ingredient. Check out other Drugs and Companies using Abrocitinib ingredient
Treatment:
Cibinqo is used for treating adults with refractory, moderate-to-severe atopic dermatitis not adequately controlled with other systemic drug products.
Dosage:
Cibinqo is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | TABLET | Prescription | ORAL |
| 200MG | TABLET | Prescription | ORAL |
| 50MG | TABLET | Prescription | ORAL |