Saphris is a drug owned by Allergan Sales Llc. It is protected by 6 US drug patents filed from 2013 to 2016. Out of these, 4 drug patents are active and 2 have expired. Saphris's patents have been open to challenges since 12 September, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 06, 2026. Details of Saphris'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. | |||
| US7741358 | Crystal form of asenapine maleate |
Apr, 2026
(10 months from now) | Active |
| US8022228 | Crystal form of asenapine maleate |
Apr, 2026
(10 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). | |||
|
US8022228 (Pediatric) | Crystal form of asenapine maleate |
Oct, 2026
(1 year, 4 months from now) | Active |
|
US7741358 (Pediatric) | Crystal form of asenapine maleate |
Oct, 2026
(1 year, 4 months from now) | Active |
|
US5763476 (Pediatric) | Sublingual or buccal pharmaceutical composition |
Dec, 2020
(4 years ago) |
Expired
|
| US5763476 | Sublingual or buccal pharmaceutical composition |
Jun, 2020
(4 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 Saphris's patents.
Latest Legal Activities on Saphris's Patents
Given below is the list of recent legal activities going on the following patents of Saphris.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Feb, 2023 | US8022228 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 11 Nov, 2021 | US7741358 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Mar, 2019 | US8022228 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Dec, 2017 | US7741358 |
| Mail-Petition Decision - Accept Late Payment of Maintenance Fees - Granted Critical | 25 Jul, 2017 | US8022228 |
| Petition Decision - Accept Late Payment of Maintenance Fees - Granted Critical | 25 Jul, 2017 | US8022228 |
| Petition to Accept Late Payment of Maintenance Fee Payment Filed Critical | 25 Jul, 2017 | US8022228 |
| Expire Patent Critical | 16 Oct, 2015 | US8022228 |
| Information Disclosure Statement (IDS) Filed Critical | 17 Jul, 2012 | US8022228 |
| Recordation of Patent Grant Mailed Critical | 20 Sep, 2011 | US8022228 |
FDA has granted several exclusivities to Saphris. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Saphris, 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 Saphris.
Exclusivity Information
Saphris holds 8 exclusivities. All of its exclusivities have expired in 2020. Details of Saphris's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-628) | Sep 03, 2013 |
| New Indication(I-629) | Sep 03, 2013 |
| New Chemical Entity Exclusivity(NCE) | Aug 13, 2014 |
| M(M-158) | Mar 12, 2018 |
| New Patient Population(NPP) | Mar 12, 2018 |
| Pediatric Exclusivity(PED) | Sep 12, 2018 |
| New Dosing Schedule(D-166) | Jan 13, 2020 |
| New Indication(I-597) | Jan 13, 2020 |
US patents provide insights into the exclusivity only within the United States, but Saphris 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 Saphris's family patents as well as insights into ongoing legal events on those patents.
Saphris's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Saphris's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 06, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Saphris Generic API suppliers:
Asenapine Maleate is the generic name for the brand Saphris. 3 different companies have already filed for the generic of Saphris, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Saphris's generic
How can I launch a generic of Saphris before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Saphris's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Saphris'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 Saphris -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg and 10 mg | 13 Aug, 2013 | 4 | 10 Dec, 2020 | 06 Apr, 2026 | Eligible |
| 2.5 mg | 27 Jul, 2017 | 1 | 10 Dec, 2020 | 06 Apr, 2026 | Deferred |
About Saphris
Saphris is a drug owned by Allergan Sales Llc. It is used for treating manic or mixed episodes associated with bipolar disorder and schizophrenia in adult and pediatric patients. Saphris uses Asenapine Maleate as an active ingredient. Saphris was launched by Allergan in 2015.
Approval Date:
Saphris was approved by FDA for market use on 12 March, 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 Saphris is 12 March, 2015, its NCE-1 date is estimated to be 12 September, 2017.
Active Ingredient:
Saphris uses Asenapine Maleate as the active ingredient. Check out other Drugs and Companies using Asenapine Maleate ingredient
Treatment:
Saphris is used for treating manic or mixed episodes associated with bipolar disorder and schizophrenia in adult and pediatric patients.
Dosage:
Saphris is available in tablet form for sublingual use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 2.5MG BASE | TABLET | Prescription | SUBLINGUAL |
| EQ 10MG BASE | TABLET | Prescription | SUBLINGUAL |
| EQ 5MG BASE | TABLET | Prescription | SUBLINGUAL |