ASENAPINE MALEATE - Generic Drug Details
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What are the generic sources for asenapine maleate and what is the scope of freedom to operate?
Asenapine maleate
is the generic ingredient in two branded drugs marketed by Alembic, Breckenridge, Sigmapharm Labs Llc, and Allergan, and is included in four NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.There are twelve drug master file entries for asenapine maleate. Seven suppliers are listed for this compound.
Summary for ASENAPINE MALEATE
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 4 |
NDAs: | 4 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 64 |
Clinical Trials: | 2 |
Patent Applications: | 163 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ASENAPINE MALEATE |
What excipients (inactive ingredients) are in ASENAPINE MALEATE? | ASENAPINE MALEATE excipients list |
DailyMed Link: | ASENAPINE MALEATE at DailyMed |
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 |
Sun Pharmaceutical Industries Limited | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Allergan | SAPHRIS | asenapine maleate | TABLET;SUBLINGUAL | 022117-003 | Mar 12, 2015 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Allergan | SAPHRIS | asenapine maleate | TABLET;SUBLINGUAL | 022117-003 | Mar 12, 2015 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Breckenridge | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 205960-002 | Dec 10, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Sigmapharm Labs Llc | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206107-002 | Dec 10, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Alembic | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206098-001 | 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 |
Expired US Patents for ASENAPINE MALEATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Allergan | SAPHRIS | asenapine maleate | TABLET;SUBLINGUAL | 022117-003 | Mar 12, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | SAPHRIS | asenapine maleate | TABLET;SUBLINGUAL | 022117-002 | Aug 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Allergan | SAPHRIS | asenapine maleate | TABLET;SUBLINGUAL | 022117-001 | Aug 13, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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