Olpruva Patent Expiration

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

(12 years from now)

Active
US11433041 Palatable compositions including sodium phenylbutyrate and uses thereof
Oct, 2036

(12 years from now)

Active
US11154521 Palatable compositions including sodium phenylbutyrate and uses thereof
Oct, 2036

(12 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.

Given below is the list of recent legal activities going on the following patents of Olpruva.

Activity Date Patent Number
Patent litigations
Change in Power of Attorney (May Include Associate POA) 02 Apr, 2024 US11202767
Change in Power of Attorney (May Include Associate POA) 02 Apr, 2024 US11154521
Email Notification 02 Apr, 2024 US11433041
Change in Power of Attorney (May Include Associate POA) 02 Apr, 2024 US11433041
Patent Issue Date Used in PTA Calculation 06 Sep, 2022 US11433041
Recordation of Patent Grant Mailed 06 Sep, 2022 US11433041
Email Notification 18 Aug, 2022 US11433041
Issue Notification Mailed 17 Aug, 2022 US11433041
Application Is Considered Ready for Issue 04 Aug, 2022 US11433041
Dispatch to FDC 04 Aug, 2022 US11433041

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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

Olpruva has patent protection in a total of 20 countries. It's US patent count contributes only to 24.1% of its total global patent coverage. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Olpruva.

Family Patents

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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 Generics:

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
Relyvrio


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