Olpruva is a drug owned by Acer Therapeutics Inc. It is protected by 3 US drug patents filed in 2023 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 17, 2036. Details of Olpruva'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). | |||
| US11202767 | Methods of treating urea cycle disorders and maple syrup urine disease |
Oct, 2036
(11 years from now) | Active |
| US11433041 | Palatable compositions including sodium phenylbutyrate and uses thereof |
Oct, 2036
(11 years from now) | Active |
| US11154521 | Palatable compositions including sodium phenylbutyrate and uses thereof |
Oct, 2036
(11 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 Olpruva's patents.
Latest Legal Activities on Olpruva's Patents
Given below is the list of recent legal activities going on the following patents of Olpruva.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Change in Power of Attorney (May Include Associate POA) Critical | 02 Apr, 2024 | US11202767 |
| Change in Power of Attorney (May Include Associate POA) Critical | 02 Apr, 2024 | US11154521 |
| Email Notification Critical | 02 Apr, 2024 | US11433041 |
| Change in Power of Attorney (May Include Associate POA) Critical | 02 Apr, 2024 | US11433041 |
| Patent Issue Date Used in PTA Calculation Critical | 06 Sep, 2022 | US11433041 |
| Recordation of Patent Grant Mailed Critical | 06 Sep, 2022 | US11433041 |
| Email Notification Critical | 18 Aug, 2022 | US11433041 |
| Issue Notification Mailed Critical | 17 Aug, 2022 | US11433041 |
| Application Is Considered Ready for Issue Critical | 04 Aug, 2022 | US11433041 |
| Dispatch to FDC | 04 Aug, 2022 | US11433041 |
US patents provide insights into the exclusivity only within the United States, but Olpruva 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 Olpruva's family patents as well as insights into ongoing legal events on those patents.
Olpruva's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Olpruva's generic launch date based on the expiry of its last outstanding patent is estimated to be Oct 17, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Olpruva Generic API suppliers:
Sodium Phenylbutyrate is the generic name for the brand Olpruva. 4 different companies have already filed for the generic of Olpruva, with Endo Operations having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Olpruva's generic
Alternative Brands for Olpruva
Olpruva which is used for treating urea cycle disorders involving enzyme deficiencies., has several other brand drugs using the same active ingredient (Sodium Phenylbutyrate). 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 | |
|---|---|---|
| Amylyx |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Sodium Phenylbutyrate, Olpruva's active ingredient. Check the complete list of approved generic manufacturers for Olpruva
About Olpruva
Olpruva is a drug owned by Acer Therapeutics Inc. It is used for treating urea cycle disorders involving enzyme deficiencies. Olpruva uses Sodium Phenylbutyrate as an active ingredient. Olpruva was launched by Acer in 2022.
Approval Date:
Olpruva was approved by FDA for market use on 22 December, 2022.
Active Ingredient:
Olpruva uses Sodium Phenylbutyrate as the active ingredient. Check out other Drugs and Companies using Sodium Phenylbutyrate ingredient
Treatment:
Olpruva is used for treating urea cycle disorders involving enzyme deficiencies.
Dosage:
Olpruva is available in for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2GM/PACKET | FOR SUSPENSION | Prescription | ORAL |
| 3GM/PACKET | FOR SUSPENSION | Prescription | ORAL |
| 4GM/PACKET | FOR SUSPENSION | Prescription | ORAL |
| 5GM/PACKET | FOR SUSPENSION | Prescription | ORAL |
| 6GM/PACKET | FOR SUSPENSION | Prescription | ORAL |
| 6.67GM/PACKET | FOR SUSPENSION | Prescription | ORAL |