Xuriden is a drug owned by Btg International Inc. It is protected by 1 US drug patent filed in 2015 out of which all have expired. Xuriden's patents have been open to challenges since 05 September, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 10, 2023. Details of Xuriden's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US6258795 | Acylated uridine and cytidine and uses thereof |
Jul, 2023
(1 year, 4 months ago) |
Expired
|
FDA has granted several exclusivities to Xuriden. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xuriden, 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 Xuriden.
Exclusivity Information
Xuriden holds 3 exclusivities. All of its exclusivities have expired in 2022. Details of Xuriden's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 04, 2020 |
| Orphan Drug Exclusivity(ODE) | Sep 04, 2022 |
| Orphan Drug Exclusivity(ODE-98) | Sep 04, 2022 |
US patents provide insights into the exclusivity only within the United States, but Xuriden 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 Xuriden's family patents as well as insights into ongoing legal events on those patents.
Xuriden's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xuriden's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 10, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xuriden Generics:
There are no approved generic versions for Xuriden as of now.
Alternative Brands for Xuriden
There are several other brand drugs using the same active ingredient (Uridine Triacetate) as Xuriden. 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 | |
|---|---|---|
| Btg Intl |
|
About Xuriden
Xuriden is a drug owned by Btg International Inc. Xuriden uses Uridine Triacetate as an active ingredient. Xuriden was launched by Btg Intl in 2015.
Approval Date:
Xuriden was approved by FDA for market use on 04 September, 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 Xuriden is 04 September, 2015, its NCE-1 date is estimated to be 05 September, 2019.
Active Ingredient:
Xuriden uses Uridine Triacetate as the active ingredient. Check out other Drugs and Companies using Uridine Triacetate ingredient
Dosage:
Xuriden is available in granule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2GM/PACKET | GRANULE | Prescription | ORAL |