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.
Summary for ASENAPINE MALEATE
Recent Clinical Trials for ASENAPINE MALEATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Amneal Pharmaceuticals, LLC | Phase 2/Phase 3 |
Accutest Research Laboratories (I) Pvt. Ltd. | 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sigmapharm Labs Llc | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206107-001 | Dec 10, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Breckenridge | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 205960-001 | Dec 10, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sigmapharm Labs Llc | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206107-002 | Dec 10, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Alembic | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206098-001 | Dec 10, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |