ASENAPINE MALEATE Drug Patent Profile
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Which patents cover Asenapine Maleate, and what generic alternatives are available?
Asenapine Maleate is a drug marketed by Alembic, Breckenridge, and Sigmapharm Labs Llc. and is included in three NDAs.
The generic ingredient in ASENAPINE MALEATE is asenapine maleate. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the asenapine maleate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Asenapine Maleate
A generic version of ASENAPINE MALEATE was approved as asenapine maleate by ALEMBIC on December 10th, 2020.
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Summary for ASENAPINE MALEATE
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 5 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Clinical Trials: | 2 |
| Patent Applications: | 77 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ASENAPINE MALEATE |
| DailyMed Link: | ASENAPINE MALEATE at DailyMed |
Recent Clinical Trials for ASENAPINE MALEATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Accutest Research Laboratories (I) Pvt. Ltd. | Phase 2/Phase 3 |
| Amneal Pharmaceuticals, LLC | Phase 2/Phase 3 |
| bioRASI, LLC | Phase 1 |
Pharmacology for ASENAPINE MALEATE
| Drug Class | Atypical Antipsychotic |
Anatomical Therapeutic Chemical (ATC) Classes for ASENAPINE MALEATE
Paragraph IV (Patent) Challenges for ASENAPINE MALEATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SAPHRIS | Sublingual Tablets | asenapine maleate | 2.5 mg | 022117 | 1 | 2017-07-27 |
| SAPHRIS | Sublingual Tablets | asenapine maleate | 5 mg and 10 mg | 022117 | 4 | 2013-08-13 |
US Patents and Regulatory Information for ASENAPINE MALEATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206098-003 | Jul 19, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sigmapharm Labs Llc | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206107-001 | Dec 10, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Breckenridge | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 205960-001 | Dec 10, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
