Rexulti is a drug owned by Otsuka Pharmaceutical Co Ltd. It is protected by 12 US drug patents filed from 2015 to 2024 out of which none have expired yet. Rexulti's patents will be open to challenges from 10 November, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 12, 2033. Details of Rexulti'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. | |||
| USRE48059 | Piperazine-substituted benzothiophenes for treatment of mental disorders |
Dec, 2028
(4 years from now) | Active |
| US7888362 | Piperazine-substituted benzothiophenes for treatment of mental disorders |
Apr, 2026
(1 year, 4 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US10307419 (Pediatric) | Tablet comprising 7-[4-(4-benzo[b]thiopen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof |
Apr, 2033
(8 years from now) | Active |
| US10307419 | Tablet comprising 7-[4-(4-benzo[b]thiopen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof |
Oct, 2032
(7 years from now) | Active |
|
USRE48059 (Pediatric) | Piperazine-substituted benzothiophenes for treatment of mental disorders |
Jun, 2029
(4 years from now) | Active |
|
US8349840 (Pediatric) | Piperazine-substituted benzothiophenes for treatment of mental disorders |
Oct, 2026
(1 year, 10 months from now) | Active |
|
US7888362 (Pediatric) | Piperazine-substituted benzothiophenes for treatment of mental disorders |
Oct, 2026
(1 year, 10 months from now) | Active |
|
US9839637 (Pediatric) | Piperazine-substituted benzothiophenes for treatment of mental disorders |
Oct, 2026
(1 year, 10 months from now) | Active |
|
US8618109 (Pediatric) | Piperazine-substituted benzothiophenes for treatment of mental disorders |
Oct, 2026
(1 year, 10 months from now) | Active |
| US8618109 | Piperazine-substituted benzothiophenes for treatment of mental disorders |
Apr, 2026
(1 year, 4 months from now) | Active |
| US9839637 | Piperazine-substituted benzothiophenes for treatment of mental disorders |
Apr, 2026
(1 year, 4 months from now) | Active |
| US8349840 | Piperazine-substituted benzothiophenes for treatment of mental disorders |
Apr, 2026
(1 year, 4 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 Rexulti's patents.
Latest Legal Activities on Rexulti's Patents
Given below is the list of recent legal activities going on the following patents of Rexulti.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 26 Jun, 2024 | US8349840 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 16 Nov, 2022 | US10307419 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jun, 2021 | US8618109 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 May, 2021 | US9839637 |
| Mail-Petition Decision - Granted | 08 Oct, 2020 | US7888362 |
| Petition Decision - Granted Critical | 06 Oct, 2020 | US7888362 |
| Petition Entered | 06 Jul, 2020 | US7888362 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Jun, 2020 | US8349840 |
| Mail Certificate of Correction Memo | 27 Sep, 2019 | US10307419 |
| Post Issue Communication - Certificate of Correction | 26 Sep, 2019 | US10307419 |
FDA has granted several exclusivities to Rexulti. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Rexulti, 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 Rexulti.
Exclusivity Information
Rexulti holds 6 exclusivities out of which 2 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Rexulti's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| M(M-186) | Sep 23, 2019 |
| New Chemical Entity Exclusivity(NCE) | Jul 10, 2020 |
| New Patient Population(NPP) | Dec 27, 2024 |
| New Indication(I-913) | May 10, 2026 |
| Pediatric Exclusivity(PED) | Nov 10, 2026 |
| M(M-14) | May 08, 2027 |
Several oppositions have been filed on Rexulti's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Rexulti's generic, the next section provides detailed information on ongoing and past EP oppositions related to Rexulti patents.
Rexulti's Oppositions Filed in EPO
Rexulti has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 11, 2020, by Maiwald Patent- Und Rechtsanwaltsgesellschaft Mbh. This opposition was filed on patent number EP12840025A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP12840025A | Aug, 2020 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP12840025A | Aug, 2020 | Maiwald Patent- und Rechtsanwaltsgesellschaft mbH | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Rexulti 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 Rexulti's family patents as well as insights into ongoing legal events on those patents.
Rexulti's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Rexulti's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 12, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Rexulti Generic API suppliers:
Brexpiprazole is the generic name for the brand Rexulti. 10 different companies have already filed for the generic of Rexulti, with Ajanta Pharma Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Rexulti's generic
How can I launch a generic of Rexulti before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Rexulti's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Rexulti'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 Rexulti -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg | 10 Jul, 2019 | 18 | 11 Aug, 2022 | 12 Oct, 2032 | Deferred |
Alternative Brands for Rexulti
Rexulti which is used for treating major depressive disorder (MDD) and schizophrenia in adults and pediatric patients ages 13 years and older., has several other brand drugs in the same treatment category . 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 | Treatment Area | ||||||
|---|---|---|---|---|---|---|---|---|
| Alkermes Inc |
| |||||||
| Indivior |
| |||||||
| Intra-cellular |
| |||||||
| Janssen Pharms |
| |||||||
| Otsuka |
| |||||||
| Otsuka Pharm Co Ltd |
| |||||||
| Sunovion Pharms Inc |
| |||||||
| Teva |
| |||||||
About Rexulti
Rexulti is a drug owned by Otsuka Pharmaceutical Co Ltd. It is used for treating major depressive disorder (MDD) and schizophrenia in adults and pediatric patients ages 13 years and older. Rexulti uses Brexpiprazole as an active ingredient. Rexulti was launched by Otsuka in 2015.
Approval Date:
Rexulti was approved by FDA for market use on 10 July, 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 Rexulti is 10 July, 2015, its NCE-1 date is estimated to be 10 November, 2025.
Active Ingredient:
Rexulti uses Brexpiprazole as the active ingredient. Check out other Drugs and Companies using Brexpiprazole ingredient
Treatment:
Rexulti is used for treating major depressive disorder (MDD) and schizophrenia in adults and pediatric patients ages 13 years and older.
Dosage:
Rexulti is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.25MG | TABLET | Prescription | ORAL |
| 3MG | TABLET | Prescription | ORAL |
| 2MG | TABLET | Prescription | ORAL |
| 1MG | TABLET | Prescription | ORAL |
| 0.5MG | TABLET | Prescription | ORAL |
| 4MG | TABLET | Prescription | ORAL |