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. Xadago's patents have been open to challenges since 21 March, 2021. 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 protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8076515 | Process for the production of 2-[4-(3- and 2-fluorobenzyloxy) benzylamino] propanamides |
Dec, 2028
(3 years from now) | Active |
| US8278485 | Process for the production of 2-[4-(3- and 2-fluorobenzyloxy) benzylamino] propanamides |
Jun, 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). | |||
| US8283380 | Methods for treatment of parkinson's disease |
Mar, 2031
(6 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 Xadago's patents.
Latest Legal Activities on Xadago's Patents
Given below is the list of recent legal activities going on the following patents of Xadago.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Apr, 2024 | US8283380 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Apr, 2024 | US8278485 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 13 Jun, 2023 | US8076515 |
| Patent Term Extension Certificate Critical | 21 May, 2021 | US8283380 |
| Withdrawal of Application for PTE Critical | 20 May, 2021 | US8076515 |
| Election in Response to Notice of Final Determination | 16 Mar, 2021 | US8283380 |
| Notice of Final Determination -Election Required | 09 Mar, 2021 | US8283380 |
| Notice of Final Determination -Election Required | 09 Mar, 2021 | US8076515 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Apr, 2020 | US8283380 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Apr, 2020 | US8278485 |
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 |
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
Explore Our Curated Drug Screens
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 Generic API suppliers:
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.
Approval Date:
Xadago was approved by FDA for market use on 21 March, 2017.
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 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 50MG BASE | TABLET | Prescription | ORAL |
| EQ 100MG BASE | TABLET | Prescription | ORAL |