Asenapine maleate - Generic Drug Details
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What are the generic drug 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 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| Alembic | ASENAPINE MALEATE | asenapine maleate | TABLET;SUBLINGUAL | 206098-002 | 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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