Latuda is a drug owned by Sunovion Pharmaceuticals Inc. It is protected by 17 US drug patents filed from 2014 to 2023. Out of these, 12 drug patents are active and 5 have expired. Latuda's patents have been open to challenges since 28 July, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 23, 2031. Details of Latuda'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. | |||
| USRE45573 | Process for producing imide compound |
Jun, 2025
(6 months from now) | Active |
| US5532372 | Imide derivatives, and their production and use |
Jul, 2018
(6 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
|
US9259423 (Pediatric) | Method of treatment for mental disorders |
Nov, 2031
(7 years from now) | Active |
| US9259423 | Method of treatment for mental disorders |
May, 2031
(6 years from now) | Active |
| US9827242 | Method of treatment for mental disorders |
May, 2031
(6 years from now) | Active |
|
US8883794 (Pediatric) | Pharmaceutical composition |
Nov, 2026
(2 years from now) | Active |
|
US8729085 (Pediatric) | Pharmaceutical composition |
Nov, 2026
(2 years from now) | Active |
|
US9907794 (Pediatric) | Pharmaceutical composition |
Nov, 2026
(2 years from now) | Active |
| US8729085 | Pharmaceutical composition |
May, 2026
(1 year, 6 months from now) | Active |
| US9555027 | Pharmaceutical composition |
May, 2026
(1 year, 6 months from now) | Active |
| US9907794 | Pharmaceutical composition |
May, 2026
(1 year, 6 months from now) | Active |
| US8883794 | Pharmaceutical composition |
May, 2026
(1 year, 6 months from now) | Active |
|
USRE45573 (Pediatric) | Process for producing imide compound |
Dec, 2025
(1 year, 30 days from now) | Active |
|
US9174975 (Pediatric) | Remedy for integration dysfunction syndrome |
Aug, 2024
(3 months ago) |
Expired
|
| US9815827 | Agent for treatment of schizophrenia |
Feb, 2024
(9 months ago) |
Expired
|
| US9174975 | Remedy for integration dysfunction syndrome |
Feb, 2024
(9 months ago) |
Expired
|
|
US5532372 (Pediatric) | Imide derivatives, and their production and use |
Jan, 2019
(5 years ago) |
Expired
|
| US5532372 | Imide derivatives, and their production and use |
Jul, 2018
(6 years ago) |
Expired
|
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 Latuda's patents.
Latest Legal Activities on Latuda's Patents
Given below is the list of recent legal activities going on the following patents of Latuda.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 May, 2022 | US8883794 (Litigated) |
| Termination or Final Written Decision | 07 Dec, 2021 | US9815827 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Nov, 2021 | US8729085 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Sep, 2021 | US9907794 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 May, 2021 | US9827242 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 05 May, 2021 | US9815827 |
| Request for Trial Granted Critical | 09 Dec, 2020 | US9815827 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 20 Jul, 2020 | US9555027 |
| Petition Requesting Trial | 05 Jun, 2020 | US9815827 |
| Post Issue Communication - Certificate of Correction | 27 Jun, 2018 | US9907794 |
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 Latuda and ongoing litigations to help you estimate the early arrival of Latuda generic.
Latuda's Litigations
Latuda been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 18, 2017, against patent number US9555027. The petitioner Par Pharmaceutical, Inc., challenged the validity of this patent, with Sumitomo Dainippon Pharma Co., Ltd. as the respondent. Click below to track the latest information on how companies are challenging Latuda's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9815827 | June, 2020 |
Final Written Decision
(07 Dec, 2021) | Sumitomo Dainippon Pharma Co., Ltd. et al. | Slayback Pharma LLC et al. |
| US9555027 | April, 2017 |
Terminated-Settled
(14 Aug, 2017) | Sumitomo Dainippon Pharma Co., Ltd. | Par Pharmaceutical, Inc. |
FDA has granted some exclusivities to Latuda. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Latuda, 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 Latuda.
Exclusivity Information
Latuda holds 6 exclusivities. All of its exclusivities have expired in 2021. Details of Latuda's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosing Schedule(D-134) | Apr 26, 2015 |
| New Chemical Entity Exclusivity(NCE) | Oct 28, 2015 |
| New Indication(I-674) | Jun 28, 2016 |
| M(M-195) | Jan 27, 2020 |
| Pediatric Exclusivity(PED) | Jul 27, 2020 |
| New Patient Population(NPP) | Mar 05, 2021 |
US patents provide insights into the exclusivity only within the United States, but Latuda 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 Latuda's family patents as well as insights into ongoing legal events on those patents.
Latuda's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Latuda's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 23, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Latuda Generic API suppliers:
Lurasidone Hydrochloride is the generic name for the brand Latuda. 18 different companies have already filed for the generic of Latuda, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Latuda's generic
How can I launch a generic of Latuda before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Latuda's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Latuda'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 Latuda -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg | 28 Oct, 2014 | 14 | 03 Jan, 2019 | 26 May, 2026 | Extinguished Eligible |
Alternative Brands for Latuda
Latuda which is used for treating bipolar depression, major depressive episodes, and schizophrenia with improvement in attention function, negative symptoms, and cognitive dysfunction., 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 |
| |||||||||
| Teva |
| |||||||||
About Latuda
Latuda is a drug owned by Sunovion Pharmaceuticals Inc. It is used for treating bipolar depression, major depressive episodes, and schizophrenia with improvement in attention function, negative symptoms, and cognitive dysfunction. Latuda uses Lurasidone Hydrochloride as an active ingredient. Latuda was launched by Sunovion Pharms Inc in 2011.
Approval Date:
Latuda was approved by FDA for market use on 07 December, 2011.
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 Latuda is 07 December, 2011, its NCE-1 date is estimated to be 28 July, 2019.
Active Ingredient:
Latuda uses Lurasidone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Lurasidone Hydrochloride ingredient
Treatment:
Latuda is used for treating bipolar depression, major depressive episodes, and schizophrenia with improvement in attention function, negative symptoms, and cognitive dysfunction.
Dosage:
Latuda is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 120MG | TABLET | Prescription | ORAL |
| 20MG | TABLET | Prescription | ORAL |
| 40MG | TABLET | Prescription | ORAL |
| 80MG | TABLET | Prescription | ORAL |
| 60MG | TABLET | Prescription | ORAL |