Odomzo is a drug owned by Sun Pharmaceutical Industries Ltd. It is protected by 3 US drug patents filed from 2015 to 2022 out of which none have expired yet. Odomzo's patents have been open to challenges since 25 July, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 30, 2036. Details of Odomzo'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. | |||
| US10266523 | Crystaline forms of N-[6-(cis-2,6-dimethylmorpholine-4-yl)pyridine-3-yl]-2-Methyl-4′-(trifluoromethoxy) [1,1′-biphenyl]-3-Methanamide monophosphate, and process of preparation thereof |
Mar, 2036
(10 years from now) | Active |
| US8063043 | Salts of N-[6-cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4′-(trifluoromethoxy)[1,1′-biphenyl]-3-carboxamide |
Sep, 2029
(4 years from now) | Active |
| US8178563 | Compounds and compositions as hedgehog pathway modulators |
Jul, 2029
(4 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 Odomzo's patents.
Latest Legal Activities on Odomzo's Patents
Given below is the list of recent legal activities going on the following patents of Odomzo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 Nov, 2023 | US8178563 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 May, 2023 | US8063043 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 Oct, 2022 | US10266523 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 26 Sep, 2022 | US10266523 |
| Change in Power of Attorney (May Include Associate POA) Critical | 22 Apr, 2022 | US10266523 |
| Correspondence Address Change Critical | 21 Apr, 2022 | US10266523 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Jul, 2021 | US8178563 |
| Correspondence Address Change Critical | 30 Jun, 2021 | US8178563 |
| Change in Power of Attorney (May Include Associate POA) Critical | 23 Nov, 2020 | US8178563 |
| Patent Term Extension Certificate Critical | 23 Oct, 2020 | US8178563 |
FDA has granted several exclusivities to Odomzo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Odomzo, 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 Odomzo.
Exclusivity Information
Odomzo holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Odomzo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 24, 2020 |
US patents provide insights into the exclusivity only within the United States, but Odomzo 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 Odomzo's family patents as well as insights into ongoing legal events on those patents.
Odomzo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Odomzo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 30, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Odomzo Generics:
There are no approved generic versions for Odomzo as of now.
About Odomzo
Odomzo is a drug owned by Sun Pharmaceutical Industries Ltd. It is used for treating basal cell carcinoma. Odomzo uses Sonidegib Phosphate as an active ingredient. Odomzo was launched by Sun Pharm in 2015.
Approval Date:
Odomzo was approved by FDA for market use on 24 July, 2015.
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 Odomzo is 24 July, 2015, its NCE-1 date is estimated to be 25 July, 2019.
Active Ingredient:
Odomzo uses Sonidegib Phosphate as the active ingredient. Check out other Drugs and Companies using Sonidegib Phosphate ingredient
Treatment:
Odomzo is used for treating basal cell carcinoma.
Dosage:
Odomzo is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE | CAPSULE | Prescription | ORAL |