Asenapine Maleate Patent Expiration

Asenapine Maleate is Used for treating manic or mixed episodes associated with bipolar disorder and schizophrenia in adult and pediatric patients. It was first introduced by Allergan Sales Llc in its drug Saphris on Aug 13, 2009. 4 different companies have introduced drugs containing Asenapine Maleate.


Asenapine Maleate Patents

Given below is the list of patents protecting Asenapine Maleate, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Saphris US5763476 Sublingual or buccal pharmaceutical composition Jun 09, 2020

(Expired)

Allergan
Saphris US5763476

(Pediatric)

Sublingual or buccal pharmaceutical composition Dec 09, 2020

(Expired)

Allergan
Saphris US7741358 Crystal form of asenapine maleate Apr 06, 2026 Allergan
Saphris US7741358

(Pediatric)

Crystal form of asenapine maleate Oct 06, 2026 Allergan
Saphris US8022228 Crystal form of asenapine maleate Apr 06, 2026 Allergan
Saphris US8022228

(Pediatric)

Crystal form of asenapine maleate Oct 06, 2026 Allergan


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 Asenapine Maleate's patents.

Given below is the list recent legal activities going on the following patents of Asenapine Maleate.

Event Date Patent/Publication
Patent litigations
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 25 Jul, 2017 US8022228
Petition Decision - Accept Late Payment of Maintenance Fees - Granted 25 Jul, 2017 US8022228
Petition to Accept Late Payment of Maintenance Fee Payment Filed 25 Jul, 2017 US8022228
Expire Patent 16 Oct, 2015 US8022228
Information Disclosure Statement (IDS) Filed 17 Jul, 2012 US8022228
Recordation of Patent Grant Mailed 20 Sep, 2011 US8022228



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Asenapine Maleate Generics

Several generic applications have been filed for Asenapine Maleate. The first generic version for Asenapine Maleate was by Alembic Pharmaceuticals Ltd and was approved on Dec 10, 2020. And the latest generic version is by Alembic Pharmaceuticals Ltd and was approved on Jul 19, 2021.

Given below is the list of companies who have filed for Asenapine Maleate generic.


1. SIGMAPHARM LABS LLC

Sigmapharm Laboratories Llc has filed for 2 different strengths of generic version for Asenapine Maleate. Given below are the details of the strengths of this generic introduced by Sigmapharm Labs Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 10MG BASE tablet Prescription SUBLINGUAL AB Dec 10, 2020
EQ 5MG BASE tablet Prescription SUBLINGUAL AB Dec 10, 2020


2. BRECKENRIDGE

Breckenridge Pharmaceutical Inc has filed for 3 different strengths of generic version for Asenapine Maleate. Given below are the details of the strengths of this generic introduced by Breckenridge.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 2.5MG BASE tablet Prescription SUBLINGUAL AB Dec 10, 2020
EQ 10MG BASE tablet Prescription SUBLINGUAL AB Dec 10, 2020
EQ 5MG BASE tablet Prescription SUBLINGUAL AB Mar 8, 2021


3. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 3 different strengths of generic version for Asenapine Maleate. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
EQ 5MG BASE tablet Prescription SUBLINGUAL AB Dec 10, 2020
EQ 10MG BASE tablet Prescription SUBLINGUAL AB Dec 10, 2020
EQ 2.5MG BASE tablet Prescription SUBLINGUAL AB Jul 19, 2021