Dojolvi is a drug owned by Ultragenyx Pharmaceutical Inc. It is protected by 2 US drug patents filed in 2021 out of which none have expired yet. Dojolvi's patents have been open to challenges since 30 June, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 28, 2029. Details of Dojolvi'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). | |||
| US8697748 | Glycogen or polysaccharide storage disease treatment method |
Apr, 2029
(4 years from now) | Active |
| US9186344 | Glycogen or polysaccharide storage disease treatment method |
Jul, 2025
(6 months 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 Dojolvi's patents.
Latest Legal Activities on Dojolvi's Patents
Given below is the list of recent legal activities going on the following patents of Dojolvi.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent Term Extension Certificate Critical | 17 Oct, 2023 | US8697748 |
| Notice of Final Determination -Election Required | 06 Jun, 2023 | US9186344 |
| Notice of Final Determination -Election Required | 06 Jun, 2023 | US8697748 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 May, 2023 | US9186344 |
| FDA Final Eligibility Letter Critical | 29 Aug, 2022 | US8697748 |
| FDA Final Eligibility Letter Critical | 29 Aug, 2022 | US9186344 |
| transaction for FDA Determination of Regulatory Review Period | 05 Nov, 2021 | US8697748 |
| transaction for FDA Determination of Regulatory Review Period | 05 Nov, 2021 | US9186344 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Oct, 2021 | US8697748 |
| Second letter to regulating agency to determine regulatory review period | 20 May, 2021 | US8697748 |
FDA has granted several exclusivities to Dojolvi. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Dojolvi, 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 Dojolvi.
Exclusivity Information
Dojolvi holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Dojolvi's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jun 30, 2025 |
| Orphan Drug Exclusivity(ODE-311) | Jun 30, 2027 |
US patents provide insights into the exclusivity only within the United States, but Dojolvi 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 Dojolvi's family patents as well as insights into ongoing legal events on those patents.
Dojolvi's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Dojolvi's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 28, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Dojolvi Generics:
There are no approved generic versions for Dojolvi as of now.
About Dojolvi
Dojolvi is a drug owned by Ultragenyx Pharmaceutical Inc. Dojolvi uses Triheptanoin as an active ingredient. Dojolvi was launched by Ultragenyx Pharm Inc in 2020.
Approval Date:
Dojolvi was approved by FDA for market use on 30 June, 2020.
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 Dojolvi is 30 June, 2020, its NCE-1 date is estimated to be 30 June, 2024.
Active Ingredient:
Dojolvi uses Triheptanoin as the active ingredient. Check out other Drugs and Companies using Triheptanoin ingredient
Dosage:
Dojolvi is available in liquid form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100% w/w | LIQUID | Prescription | ORAL |