Scemblix is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 2 US drug patents filed from 2021 to 2024 out of which none have expired yet. Scemblix's patents will be open to challenges from 29 October, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be May 14, 2040. Details of Scemblix'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. | |||
| US11407735 | Crystalline forms of N-[4-(Chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(1H-pyrazol-5-yl)pyridine-3-carboxamide |
May, 2040
(15 years from now) | Active |
| US8829195 | Compounds and compositions for inhibiting the activity of ABL1, ABL2 and BCR-ABL1 |
May, 2033
(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 Scemblix's patents.
Latest Legal Activities on Scemblix's Patents
Given below is the list of recent legal activities going on the following patents of Scemblix.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 27 Dec, 2023 | US8829195 |
| transaction for FDA Determination of Regulatory Review Period | 30 Nov, 2023 | US8829195 |
| Second letter to regulating agency to determine regulatory review period | 26 Jan, 2023 | US8829195 |
| Letter from FDA or Dept of Agriculture re PTE application | 10 Jan, 2023 | US8829195 |
| Post Issue Communication - Certificate of Correction | 23 Aug, 2022 | US11407735 |
| Recordation of Patent Grant Mailed Critical | 09 Aug, 2022 | US11407735 |
| Patent Issue Date Used in PTA Calculation Critical | 09 Aug, 2022 | US11407735 |
| Email Notification Critical | 21 Jul, 2022 | US11407735 |
| Issue Notification Mailed Critical | 20 Jul, 2022 | US11407735 |
| Application Is Considered Ready for Issue Critical | 07 Jul, 2022 | US11407735 |
FDA has granted several exclusivities to Scemblix. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Scemblix, 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 Scemblix.
Exclusivity Information
Scemblix holds 8 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Scemblix's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 29, 2026 |
| New Indication(I-953) | Oct 29, 2027 |
| New Indication(I-954) | Oct 29, 2027 |
| ODE*(ODE*) | Oct 29, 2028 |
| Orphan Drug Exclusivity(ODE-381) | Oct 29, 2028 |
| Orphan Drug Exclusivity(ODE-382) | Oct 29, 2028 |
| Orphan Drug Exclusivity(ODE-499) | Oct 29, 2031 |
| Orphan Drug Exclusivity(ODE-500) | Oct 29, 2031 |
US patents provide insights into the exclusivity only within the United States, but Scemblix 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 Scemblix's family patents as well as insights into ongoing legal events on those patents.
Scemblix's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Scemblix's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 14, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Scemblix Generics:
There are no approved generic versions for Scemblix as of now.
Alternative Brands for Scemblix
Scemblix which is used for treating Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML)., 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 | ||
|---|---|---|---|---|
| Novartis |
| |||
About Scemblix
Scemblix is a drug owned by Novartis Pharmaceuticals Corp. It is used for treating Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML). Scemblix uses Asciminib Hydrochloride as an active ingredient. Scemblix was launched by Novartis in 2021.
Approval Date:
Scemblix was approved by FDA for market use on 29 October, 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 Scemblix is 29 October, 2021, its NCE-1 date is estimated to be 29 October, 2025.
Active Ingredient:
Scemblix uses Asciminib Hydrochloride as the active ingredient. Check out other Drugs and Companies using Asciminib Hydrochloride ingredient
Treatment:
Scemblix is used for treating Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML).
Dosage:
Scemblix is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 40MG BASE | TABLET | Prescription | ORAL |
| EQ 20MG BASE | TABLET | Prescription | ORAL |
| EQ 100MG BASE | TABLET | Prescription | ORAL |