Iclusig is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 6 US drug patents filed from 2013 to 2022 out of which none have expired yet. Iclusig's patents have been open to challenges since 14 December, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 12, 2033. Details of Iclusig'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. | |||
| US9493470 | Crystalline forms of 3-(imidazo[1,2-B] pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl) methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt |
Dec, 2033
(8 years from now) | Active |
| US11192897 | Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt |
Dec, 2033
(8 years from now) | Active |
| US11384086 | Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-n-{4-[(4-methylpiperazin-1- yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt |
Dec, 2033
(8 years from now) | Active |
| US8114874 | Substituted acetylenic imidazo[1,2-B]pyridazine compounds as kinase inhibitors |
Jan, 2027
(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). | |||
| US11192895 | Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-n-{4-[(4-methylpiperazin-1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt |
Dec, 2033
(8 years from now) | Active |
| US9029533 | Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors |
Dec, 2026
(1 year, 11 months 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 Iclusig's patents.
Latest Legal Activities on Iclusig's Patents
Given below is the list of recent legal activities going on the following patents of Iclusig.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Apr, 2024 | US9493470 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Jul, 2023 | US8114874 (Litigated) |
| Email Notification Critical | 27 Oct, 2022 | US11384086 |
| Mail Certificate of Correction Memo | 26 Oct, 2022 | US11384086 |
| Post Issue Communication - Certificate of Correction | 24 Oct, 2022 | US11384086 |
| Certificate of Correction Memo | 24 Oct, 2022 | US11384086 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Oct, 2022 | US9029533 |
| Recordation of Patent Grant Mailed Critical | 12 Jul, 2022 | US11384086 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Jul, 2022 | US11384086 |
| Email Notification Critical | 23 Jun, 2022 | US11384086 |
FDA has granted several exclusivities to Iclusig. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Iclusig, 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 Iclusig.
Exclusivity Information
Iclusig holds 6 exclusivities out of which 4 have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Iclusig's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 14, 2017 |
| Orphan Drug Exclusivity(ODE) | Dec 14, 2019 |
| Orphan Drug Exclusivity(ODE-35) | Dec 14, 2019 |
| New Indication(I-849) | Dec 18, 2023 |
| New Indication(I-934) | Mar 19, 2027 |
| Orphan Drug Exclusivity(ODE-472) | Mar 19, 2031 |
US patents provide insights into the exclusivity only within the United States, but Iclusig 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 Iclusig's family patents as well as insights into ongoing legal events on those patents.
Iclusig's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Iclusig's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 12, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Iclusig Generic API suppliers:
Ponatinib Hydrochloride is the generic name for the brand Iclusig. 1 company has already filed for the generic of Iclusig. Check out the entire list of companies who have already received approval for Iclusig's generic
How can I launch a generic of Iclusig before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Iclusig's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Iclusig'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 Iclusig -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 15 mg and 45 mg | 31 Mar, 2021 | 1 | 14 Jul, 2023 | 12 Dec, 2033 | Eligible |
| 10 mg and 30 mg | 12 Dec, 2022 | 1 | 12 Dec, 2033 |
Alternative Brands for Iclusig
Iclusig which is used for treating various types of leukemia, including acute lymphoblastic leukemia, chronic myeloid leukemia, and Philadelphia chromosome-positive acute lymphoblastic leukemia., has several other brand drugs in the same treatment category . 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 | ||
|---|---|---|---|---|
| Azurity |
| |||
About Iclusig
Iclusig is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating various types of leukemia, including acute lymphoblastic leukemia, chronic myeloid leukemia, and Philadelphia chromosome-positive acute lymphoblastic leukemia. Iclusig uses Ponatinib Hydrochloride as an active ingredient. Iclusig was launched by Takeda Pharms Usa in 2020.
Approval Date:
Iclusig was approved by FDA for market use on 18 December, 2020.
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 Iclusig is 18 December, 2020, its NCE-1 date is estimated to be 14 December, 2016.
Active Ingredient:
Iclusig uses Ponatinib Hydrochloride as the active ingredient. Check out other Drugs and Companies using Ponatinib Hydrochloride ingredient
Treatment:
Iclusig is used for treating various types of leukemia, including acute lymphoblastic leukemia, chronic myeloid leukemia, and Philadelphia chromosome-positive acute lymphoblastic leukemia.
Dosage:
Iclusig is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 45MG BASE | TABLET | Prescription | ORAL |
| EQ 30MG BASE | TABLET | Prescription | ORAL |
| EQ 15MG BASE | TABLET | Prescription | ORAL |
| EQ 10MG BASE | TABLET | Prescription | ORAL |