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
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 |
US7741358 (Pediatric) | Crystal form of asenapine maleate | Oct 06, 2026 | Allergan |
| Saphris |
US8022228 (Pediatric) | Crystal form of asenapine maleate | Oct 06, 2026 | Allergan |
| Saphris | US7741358 | Crystal form of asenapine maleate | Apr 06, 2026 | Allergan |
| Saphris | US8022228 | Crystal form of asenapine maleate | Apr 06, 2026 | Allergan |
| Saphris |
US5763476 (Pediatric) | Sublingual or buccal pharmaceutical composition |
Dec 09, 2020
(Expired) | Allergan |
| Saphris | US5763476 | Sublingual or buccal pharmaceutical composition |
Jun 09, 2020
(Expired) | 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.
Latest Legal Activities on Asenapine Maleate's Patents
Given below is the list recent legal activities going on the following patents of Asenapine Maleate.
| 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 |
Asenapine Maleate's Family Patents
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Asenapine Maleate Generic API Manufacturers
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, along with the locations of their manufacturing plants worldwide.
1. 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 |
Manufacturing Plant Locations New
Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.
| Country | City | Firm Name | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
| |||||||||||||||
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 |
Manufacturing Plant Locations New
Breckenridge's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Breckenridge as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| United States |
| |||||
3. 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 |