Jakafi is a drug owned by Incyte Corp. It is protected by 17 US drug patents filed from 2013 to 2022 out of which none have expired yet. Jakafi's patents will be open to challenges from 22 March, 2028. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 22, 2029. Details of Jakafi'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. | |||
| US8722693 | Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile |
Jun, 2028
(3 years from now) | Active |
| US8415362 | Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors |
Dec, 2027
(3 years from now) | Active |
| US7598257 | Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors |
Dec, 2027
(3 years from now) | Active |
| US9662335 | Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors |
Dec, 2026
(2 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). | |||
|
US8722693 (Pediatric) | Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile |
Dec, 2028
(4 years from now) | Active |
|
US8829013 (Pediatric) | Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile |
Dec, 2028
(4 years from now) | Active |
|
US10016429 (Pediatric) | Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile |
Dec, 2028
(4 years from now) | Active |
|
US8822481 (Pediatric) | Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile |
Dec, 2028
(4 years from now) | Active |
|
US8415362 (Pediatric) | Pyrazolyl substituted pyrrolo[2,3-b]pyrimidines as Janus kinase inhibitors |
Jun, 2028
(3 years from now) | Active |
|
US7598257 (Pediatric) | Heteroaryl substituted pyrrolo[2,3-b]pyridines and pyrrolo[2,3-b]pyrimidines as janus kinase inhibitors |
Jun, 2028
(3 years from now) | Active |
| US8822481 | Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-d] pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile |
Jun, 2028
(3 years from now) | Active |
| US8829013 | Salts of the Janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile |
Jun, 2028
(3 years from now) | Active |
| US10016429 | Salts of the janus kinase inhibitor (R)-3-(4-(7H-pyrrolo[2,3-D]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile |
Jun, 2028
(3 years from now) | Active |
|
US9814722 (Pediatric) | Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors |
Jun, 2027
(2 years from now) | Active |
|
US9079912 (Pediatric) | Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors |
Jun, 2027
(2 years from now) | Active |
| US9079912 | Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as Janus kinase inhibitors |
Dec, 2026
(2 years from now) | Active |
| US9814722 | Heteroaryl substituted pyrrolo[2,3-B] pyridines and pyrrolo[2,3-B] pyrimidines as janus kinase inhibitors |
Dec, 2026
(2 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 Jakafi's patents.
Latest Legal Activities on Jakafi's Patents
Given below is the list of recent legal activities going on the following patents of Jakafi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jan, 2023 | US9079912 |
| Mail Pub Notice re 312 amendment | 04 Jan, 2023 | US7598257 |
| Email Notification Critical | 04 Jan, 2023 | US7598257 |
| POST ISSUE OTHER COMMUNICATION TO APPLICANT- CERTIFICATE OF CORRECTION | 30 Dec, 2022 | US7598257 |
| Email Notification Critical | 24 Mar, 2022 | US9079912 |
| Mail Pub Notice re 312 amendment | 24 Mar, 2022 | US9079912 |
| Post Issue Communication - Certificate of Correction Denied | 21 Mar, 2022 | US9079912 |
| Post Issue Communication - Certificate of Correction Denied | 21 Mar, 2022 | US7598257 |
| POST ISSUE OTHER COMMUNICATION TO APPLICANT- CERTIFICATE OF CORRECTION | 21 Mar, 2022 | US9079912 |
| Email Notification Critical | 04 Mar, 2022 | US8415362 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Jakafi and ongoing litigations to help you estimate the early arrival of Jakafi generic.
Jakafi's Litigations
Jakafi been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Jun 27, 2017, against patent number US9662335. The petitioner Concert Pharmaceuticals, Inc., challenged the validity of this patent, with Incyte Corporation as the respondent. Click below to track the latest information on how companies are challenging Jakafi's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9662335 | June, 2017 |
Terminated-Denied
(11 Jan, 2018) | Incyte Corporation | Concert Pharmaceuticals, Inc. |
FDA has granted some exclusivities to Jakafi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Jakafi, 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 Jakafi.
Exclusivity Information
Jakafi holds 11 exclusivities out of which 7 have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Jakafi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 16, 2016 |
| New Indication(I-699) | Dec 04, 2017 |
| Orphan Drug Exclusivity(ODE) | Nov 16, 2018 |
| Orphan Drug Exclusivity(ODE-19) | Nov 16, 2018 |
| Orphan Drug Exclusivity(ODE-79) | Dec 04, 2021 |
| New Indication(I-799) | May 24, 2022 |
| New Indication(I-872) | Sep 22, 2024 |
| M(M-285) | Dec 19, 2025 |
| Orphan Drug Exclusivity(ODE-238) | May 24, 2026 |
| Orphan Drug Exclusivity(ODE-373) | Sep 22, 2028 |
| Pediatric Exclusivity(PED) | Mar 22, 2029 |
Several oppositions have been filed on Jakafi's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Jakafi's generic, the next section provides detailed information on ongoing and past EP oppositions related to Jakafi patents.
Jakafi's Oppositions Filed in EPO
Jakafi has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jun 21, 2012, by Fresenius Kabi Deutschland Gmbh. This opposition was filed on patent number EP06839328A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP16152794A | Sep, 2019 | Generics (UK) Ltd | Revoked |
| EP16197502A | Jun, 2019 | Concert Pharmaceuticals, Inc. | Granted and Under Opposition |
| EP08770794A | Dec, 2014 | Actavis Group PTC ehf | Patent maintained as amended |
| EP08770794A | Dec, 2014 | Generics [UK] Ltd (trading as Mylan) | Patent maintained as amended |
| EP06839328A | Jun, 2012 | Fresenius Kabi Deutschland GmbH | Opposition procedure closed |
US patents provide insights into the exclusivity only within the United States, but Jakafi 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 Jakafi's family patents as well as insights into ongoing legal events on those patents.
Jakafi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Jakafi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 22, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Jakafi Generics:
There are no approved generic versions for Jakafi as of now.
How can I launch a generic of Jakafi before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Jakafi's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Jakafi's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Jakafi -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg | 17 Dec, 2015 | 1 | 12 Jun, 2028 |
Alternative Brands for Jakafi
Jakafi which is used for treating conditions such as myelofibrosis, polycythemia vera, and steroid-refractory acute graft-versus-host disease., has several other brand drugs using the same active ingredient (Ruxolitinib Phosphate). 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.
About Jakafi
Jakafi is a drug owned by Incyte Corp. It is used for treating conditions such as myelofibrosis, polycythemia vera, and steroid-refractory acute graft-versus-host disease. Jakafi uses Ruxolitinib Phosphate as an active ingredient. Jakafi was launched by Incyte Corp in 2011.
Approval Date:
Jakafi was approved by FDA for market use on 16 November, 2011.
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 Jakafi is 16 November, 2011, its NCE-1 date is estimated to be 22 March, 2028.
Active Ingredient:
Jakafi uses Ruxolitinib Phosphate as the active ingredient. Check out other Drugs and Companies using Ruxolitinib Phosphate ingredient
Treatment:
Jakafi is used for treating conditions such as myelofibrosis, polycythemia vera, and steroid-refractory acute graft-versus-host disease.
Dosage:
Jakafi is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 20MG BASE | TABLET | Prescription | ORAL |
| EQ 15MG BASE | TABLET | Prescription | ORAL |
| EQ 10MG BASE | TABLET | Prescription | ORAL |
| EQ 5MG BASE | TABLET | Prescription | ORAL |
| EQ 25MG BASE | TABLET | Prescription | ORAL |