Odomzo Patent Expiration

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. 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 protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8178563 Compounds and compositions as hedgehog pathway modulators
Jul, 2029

(5 years from now)

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

(5 years from now)

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

(11 years from now)


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

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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

Odomzo has patent protection in a total of 49 countries. It's US patent count contributes only to 12.3% of its total global patent coverage. 11 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Odomzo.

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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.

Market Authorisation Date:

Odomzo was approved by FDA for market use on 24 July, 2015.

NCE-1 date:

NCE-1 date is also known as the four year date as it is four years after the original drug approval. 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


Odomzo is used for treating basal cell carcinoma.


Odomzo is available in capsule form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway