Vraylar is a drug owned by Abbvie Inc. It is protected by 5 US drug patents filed from 2015 to 2023 out of which none have expired yet. Vraylar's patents have been open to challenges since 18 September, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 17, 2029. Details of Vraylar's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7737142 | (Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists |
Sep, 2029
(4 years from now) | Active |
| US7943621 | Salts of piperazine compounds as D3/D2 antagonists |
Dec, 2028
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| USRE49110 | Pharmaceutical formulations containing dopamine receptor ligands |
Jul, 2029
(4 years from now) | Active |
| USRE49302 | Pharmaceutical formulations containing dopamine receptor ligands |
Jul, 2029
(4 years from now) | Active |
| USRE47350 | Pharmaceutical formulations containing dopamine receptor ligands |
Jul, 2029
(4 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 Vraylar's patents.
Latest Legal Activities on Vraylar's Patents
Given below is the list of recent legal activities going on the following patents of Vraylar.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Nov, 2022 | US7943621 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 15 Dec, 2021 | US7737142 |
| Patent Term Extension Certificate Critical | 04 Dec, 2019 | US7737142 |
| Post Issue Communication - Certificate of Correction | 09 Jun, 2019 | US7737142 |
| Mail Certificate of Correction Memo | 05 Jun, 2019 | US7737142 |
| Certificate of Correction Memo | 04 Jun, 2019 | US7737142 |
| Notice of Final Determination -Election Required | 17 Apr, 2019 | US7737142 |
| Notice of Final Determination -Election Required | 17 Apr, 2019 | US7943621 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Nov, 2018 | US7943621 |
| FDA Final Eligibility Letter Critical | 10 Oct, 2018 | US7737142 |
FDA has granted several exclusivities to Vraylar. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vraylar, 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 Vraylar.
Exclusivity Information
Vraylar holds 4 exclusivities out of which 3 have expired. Its last outstanding exclusivity is set to expire in 2025. Details of Vraylar's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 17, 2020 |
| M(M-213) | Nov 09, 2020 |
| New Indication(I-798) | May 24, 2022 |
| New Indication(I-904) | Dec 16, 2025 |
US patents provide insights into the exclusivity only within the United States, but Vraylar 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 Vraylar's family patents as well as insights into ongoing legal events on those patents.
Vraylar's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vraylar's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 17, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vraylar Generic API suppliers:
Cariprazine Hydrochloride is the generic name for the brand Vraylar. 2 different companies have already filed for the generic of Vraylar, with Sun Pharm having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Vraylar's generic
How can I launch a generic of Vraylar before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Vraylar's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vraylar'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 Vraylar -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1.5 mg, 3 mg, 4.5 mg and 6 mg | 17 Sep, 2019 | 3 | 09 Sep, 2022 | 16 Jul, 2029 | Eligible |
About Vraylar
Vraylar is a drug owned by Abbvie Inc. It is used for treating major depressive disorder, bipolar disorder, and schizophrenia. Vraylar uses Cariprazine Hydrochloride as an active ingredient. Vraylar was launched by Abbvie in 2015.
Approval Date:
Vraylar was approved by FDA for market use on 17 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 Vraylar is 17 September, 2015, its NCE-1 date is estimated to be 18 September, 2019.
Active Ingredient:
Vraylar uses Cariprazine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Cariprazine Hydrochloride ingredient
Treatment:
Vraylar is used for treating major depressive disorder, bipolar disorder, and schizophrenia.
Dosage:
Vraylar is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 6MG BASE | CAPSULE | Prescription | ORAL |
| EQ 1.5MG BASE | CAPSULE | Prescription | ORAL |
| EQ 4.5MG BASE | CAPSULE | Prescription | ORAL |
| EQ 3MG BASE | CAPSULE | Prescription | ORAL |