ASENAPINE Drug Patent Profile
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Which patents cover Asenapine, and what generic alternatives are available?
Asenapine is a drug marketed by Alembic, Breckenridge, and Sigmapharm Labs Llc. and is included in three NDAs.
The generic ingredient in ASENAPINE is asenapine maleate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the asenapine maleate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Asenapine
A generic version of ASENAPINE was approved as asenapine maleate by ALEMBIC on December 10th, 2020.
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for ASENAPINE?
- What are the global sales for ASENAPINE?
- What is Average Wholesale Price for ASENAPINE?
Summary for ASENAPINE
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Drug Prices: | Drug price information for ASENAPINE |
| What excipients (inactive ingredients) are in ASENAPINE? | ASENAPINE excipients list |
| DailyMed Link: | ASENAPINE at DailyMed |
Recent Clinical Trials for ASENAPINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Lindner Center of HOPE | Phase 2 |
| National Alliance on Mental Illness Montana | |
| CGStat LLC |
Anatomical Therapeutic Chemical (ATC) Classes for ASENAPINE
US Patents and Regulatory Information for ASENAPINE
| 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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sigmapharm Labs Llc | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206107-001 | Dec 10, 2020 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Breckenridge | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 205960-001 | Dec 10, 2020 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Sigmapharm Labs Llc | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206107-002 | Dec 10, 2020 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Alembic | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206098-001 | Dec 10, 2020 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Alembic | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206098-002 | Dec 10, 2020 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for ASENAPINE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| N.V. Organon | Sycrest | asenapine | EMEA/H/C/001177Sycrest is indicated for the treatment of moderate to severe manic episodes associated with bipolar I disorder in adults. | Authorised | no | no | no | 2010-09-01 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
