Litfulo is a drug owned by Pfizer Inc. It is protected by 3 US drug patents filed from 2023 to 2024 out of which none have expired yet. Litfulo's patents will be open to challenges from 24 June, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 17, 2041. Details of Litfulo'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. | |||
| US12116368 | Pyrrolo[2,3-d]pyrimidine tosylate salt, crystalline form thereof and manufacturing process and intermediates thereto |
Oct, 2041
(16 years from now) | Active |
| US9617258 | Pyrrolo[2,3-d]pyrimidinyl, pyrrolo[2,3-b]pyrazinyl and pyrrolo[2,3-d]pyridinyl acrylamides |
Dec, 2034
(10 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). | |||
| US12077533 | Pyrrolo[2,3-d]pyrimidinyl, pyrrolo[2,3-b]pyrazinyl and pyrrolo[2,3-d]pyridinyl acrylamides |
Dec, 2034
(10 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 Litfulo's patents.
Latest Legal Activities on Litfulo's Patents
Given below is the list of recent legal activities going on the following patents of Litfulo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US9617258 |
| Initial letter Re: PTE Application to regulating agency | 11 Oct, 2023 | US9617258 |
| Patent Term Extension Application under 35 USC 156 Filed | 11 Aug, 2023 | US9617258 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 15 Sep, 2020 | US9617258 |
| Patent Issue Date Used in PTA Calculation Critical | 11 Apr, 2017 | US9617258 |
| Recordation of Patent Grant Mailed Critical | 11 Apr, 2017 | US9617258 |
| Email Notification Critical | 23 Mar, 2017 | US9617258 |
| Issue Notification Mailed Critical | 22 Mar, 2017 | US9617258 |
| Dispatch to FDC | 08 Mar, 2017 | US9617258 |
| Application Is Considered Ready for Issue Critical | 07 Mar, 2017 | US9617258 |
FDA has granted several exclusivities to Litfulo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Litfulo, 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 Litfulo.
Exclusivity Information
Litfulo holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Litfulo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 23, 2028 |
US patents provide insights into the exclusivity only within the United States, but Litfulo 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 Litfulo's family patents as well as insights into ongoing legal events on those patents.
Litfulo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Litfulo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 17, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Litfulo Generics:
There are no approved generic versions for Litfulo as of now.
About Litfulo
Litfulo is a drug owned by Pfizer Inc. Litfulo uses Ritlecitinib Tosylate as an active ingredient. Litfulo was launched by Pfizer in 2023.
Approval Date:
Litfulo was approved by FDA for market use on 23 June, 2023.
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 Litfulo is 23 June, 2023, its NCE-1 date is estimated to be 24 June, 2027.
Active Ingredient:
Litfulo uses Ritlecitinib Tosylate as the active ingredient. Check out other Drugs and Companies using Ritlecitinib Tosylate ingredient
Dosage:
Litfulo is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 50MG BASE | CAPSULE | Prescription | ORAL |