Xadago Patent Expiration

Xadago is a drug owned by Mdd Us Operations Llc. It is protected by 3 US drug patents filed in 2017 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 21, 2031. Details of Xadago'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.
US8278485 Process for the production of 2-[4-(3- and 2-fluorobenzyloxy) benzylamino] propanamides
Jun, 2027

(2 years from now)

Active
US8076515 Process for the production of 2-[4-(3- and 2-fluorobenzyloxy) benzylamino] propanamides
Dec, 2028

(4 years from now)

Active
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8283380 Methods for treatment of parkinson's disease
Mar, 2031

(6 years from now)

Active


FDA has granted several exclusivities to Xadago. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xadago, 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 Xadago.

Exclusivity Information

Xadago holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Xadago's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE) Mar 21, 2022

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

US patents provide insights into the exclusivity only within the United States, but Xadago 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 Xadago's family patents as well as insights into ongoing legal events on those patents.

Xadago's family patents

Xadago has patent protection in a total of 32 countries. It's US patent count contributes only to 6.7% of its total global patent coverage. 2 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 Xadago.

Family Patents

Coming Soon

Patent Strength Analyzer

Will this be useful for you?

YesNo

Thank you for your response 🥳



Generic Launch

Generic Release Date:

Xadago's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 21, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Xadago Generics:

Safinamide Mesylate is the generic name for the brand Xadago. 2 different companies have already filed for the generic of Xadago, with Aurobindo Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xadago's generic





About Xadago

Xadago is a drug owned by Mdd Us Operations Llc. It is used for managing 'off' episodes in patients with Parkinson's disease who are already taking levodopa/carbidopa. Xadago uses Safinamide Mesylate as an active ingredient. Xadago was launched by Mdd Us in 2017.

Market Authorisation Date:

Xadago was approved by FDA for market use on 21 March, 2017.

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 Xadago is 21 March, 2017, its NCE-1 date is estimated to be 21 March, 2021

Active Ingredient:

Xadago uses Safinamide Mesylate as the active ingredient. Check out other Drugs and Companies using Safinamide Mesylate ingredient

Treatment:

Xadago is used for managing 'off' episodes in patients with Parkinson's disease who are already taking levodopa/carbidopa.

Dosage:

Xadago is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 100MG BASE TABLET Prescription ORAL
EQ 50MG BASE TABLET Prescription ORAL