Ravicti is a drug owned by Horizon Therapeutics Us Holding Llc. It is protected by 17 US drug patents filed from 2013 to 2020. Out of these, 16 drug patents are active and 1 has expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 09, 2032. Details of Ravicti'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US5968979 | Triglycerides and ethyl esters of phenylalkanoic acid and phenylalkenoic acid useful in treatment of various disorders |
Feb, 2015
(9 years ago) |
Expired
|
| US8642012 | Methods of treatment using ammonia-scavenging drugs |
Sep, 2030
(6 years from now) | Active |
| US10045959 | Methods of therapeutic monitoring of nitrogen scavenging drugs |
Sep, 2030
(6 years from now) | Active |
| US9962359 | Methods of therapeutic monitoring of nitrogen scavenging drugs |
Sep, 2030
(6 years from now) | Active |
| US9561197 | Methods of therapeutic monitoring of phenylacetic acid prodrugs |
Sep, 2030
(6 years from now) | Active |
| US9326966 | Methods of therapeutic monitoring of nitrogen scavenging drugs |
Sep, 2030
(6 years from now) | Active |
| US10183002 | Methods of therapeutic monitoring of nitrogen scavenging drugs |
Sep, 2030
(6 years from now) | Active |
| US10183004 | Methods of therapeutic monitoring of nitrogen scavenging drugs |
Sep, 2030
(6 years from now) | Active |
| US10668040 | Treatment of urea cycle disorders in neonates and infants |
Sep, 2030
(6 years from now) | Active |
| US10183005 | Methods of therapeutic monitoring of nitrogen scavenging drugs |
Sep, 2030
(6 years from now) | Active |
| US10183006 | Methods of therapeutic monitoring of nitrogen scavenging drugs |
Sep, 2030
(6 years from now) | Active |
| US10045958 | Methods of therapeutic monitoring of nitrogen scavenging drugs |
Sep, 2030
(6 years from now) | Active |
| US9999608 | Methods of therapeutic monitoring of nitrogen scavenging drugs |
Sep, 2030
(6 years from now) | Active |
| US9254278 | Methods of therapeutic monitoring of nitrogen scavenging drugs |
Sep, 2030
(6 years from now) | Active |
| US10183003 | Methods of therapeutic monitoring of nitrogen scavenging drugs |
Sep, 2030
(6 years from now) | Active |
| US9095559 | Methods of therapeutic monitoring of nitrogen scavenging drugs |
Mar, 2032
(7 years from now) | Active |
| US8404215 | Methods of therapeutic monitoring of nitrogen scavenging |
Mar, 2032
(7 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 Ravicti's patents.
Latest Legal Activities on Ravicti's Patents
Given below is the list of recent legal activities going on the following patents of Ravicti.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 30 Nov, 2023 | US10668040 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Oct, 2023 | US9326966 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Aug, 2023 | US9254278 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Feb, 2023 | US9095559 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Jul, 2022 | US10183002 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Jul, 2022 | US10183006 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Jul, 2022 | US10183003 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Jul, 2022 | US10183004 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 Jul, 2022 | US10183005 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Feb, 2022 | US10045959 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Ravicti and ongoing litigations to help you estimate the early arrival of Ravicti generic.
Ravicti's Litigations
Ravicti has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 29, 2015, against patent number US8642012. The petitioner Par Pharmaceutical, Inc., challenged the validity or infringement of this patent, with Horizon Therapeutics, Inc. as the respondent. Click below to track the latest information on how companies are challenging Ravicti's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9561197 | August, 2018 | Terminated-Settled | Horizon Therapeutics, LLC | Par Pharmaceutical, Inc. |
| US9561197 | January, 2018 | Terminated-Settled | Horizon Therapeutics, LLC | Lupin, Ltd. |
| US9095559 | July, 2017 | Terminated-Settled | Horizon Therapeutics, LLC | Par Pharmaceutical, Inc. |
| US9254278 | July, 2017 | Terminated-Settled | Horizon Therapeutics, LLC | Par Pharmaceutical, Inc. |
| US9326966 | July, 2017 | Terminated-Settled | Horizon Therapeutics, LLC | Par Pharmaceutical, Inc. |
| US9254278 | March, 2017 | Terminated-Settled | Horizon Therapeutics, LLC | Lupin Ltd. |
| US9326966 | March, 2017 | Terminated-Settled | Horizon Therapeutics, LLC | Lupin Ltd. |
| US9095559 | April, 2016 | FWD Entered | Horizon Therapeutics, Inc. | Lupin Ltd |
| US8404215 | December, 2015 | FWD Entered | ||
| US8642012 | December, 2015 | FWD Entered | ||
| US8404215 | April, 2015 | FWD Entered | Horizon Therapeutics, Inc. | Par Pharmaceutical, Inc. |
| US8642012 | April, 2015 | FWD Entered | Horizon Therapeutics, Inc. | Par Pharmaceutical, Inc. |
FDA has granted some exclusivities to Ravicti. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ravicti, 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 Ravicti.
Exclusivity Information
Ravicti holds 5 exclusivities. All of its exclusivities have expired in 2024. Details of Ravicti's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| NE(NE) | Feb 01, 2016 |
| Orphan Drug Exclusivity(ODE-42) | Feb 01, 2020 |
| Orphan Drug Exclusivity(ODE) | Feb 01, 2020 |
| New Patient Population(NPP) | Dec 21, 2021 |
| Orphan Drug Exclusivity(ODE-157) | Apr 28, 2024 |
US patents provide insights into the exclusivity only within the United States, but Ravicti 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 Ravicti's family patents as well as insights into ongoing legal events on those patents.
Ravicti's family patents
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Generic Launch
Generic Release Date:
Ravicti's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 09, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ravicti Generics:
Glycerol Phenylbutyrate is the generic name for the brand Ravicti. 1 company has already filed for the generic of Ravicti. Check out the entire list of companies who have already received approval for Ravicti's generic
How can I launch a generic of Ravicti before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Ravicti's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Ravicti's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Ravicti -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1.1 g/mL | 19 Nov, 2013 | 1 | 02 Dec, 2021 | 09 Mar, 2032 | Eligible |
About Ravicti
Ravicti is a drug owned by Horizon Therapeutics Us Holding Llc. It is used for managing urea cycle disorders and nitrogen metabolism disorders. Ravicti uses Glycerol Phenylbutyrate as an active ingredient. Ravicti was launched by Horizon Therap Us in 2013.
Can you believe Ravicti received compensation for the extended wait time during the regulatory approval process?
A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.
Market Authorisation Date:
Ravicti was approved by FDA for market use on 01 February, 2013.
Active Ingredient:
Ravicti uses Glycerol Phenylbutyrate as the active ingredient. Check out other Drugs and Companies using Glycerol Phenylbutyrate ingredient
Treatment:
Ravicti is used for managing urea cycle disorders and nitrogen metabolism disorders.
Dosage:
Ravicti is available in liquid form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.1GM/ML | LIQUID | Prescription | ORAL |