SAPHRIS Drug Patent Profile
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Which patents cover Saphris, and when can generic versions of Saphris launch?
Saphris is a drug marketed by Allergan and is included in one NDA. There are two patents protecting this drug and two Paragraph IV challenges.
The generic ingredient in SAPHRIS 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 Saphris
A generic version of SAPHRIS was approved as asenapine maleate by ALEMBIC on December 10th, 2020.
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Questions you can ask:
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Summary for SAPHRIS
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Clinical Trials: | 12 |
| Patent Applications: | 77 |
| Drug Prices: | Drug price information for SAPHRIS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SAPHRIS |
| What excipients (inactive ingredients) are in SAPHRIS? | SAPHRIS excipients list |
| DailyMed Link: | SAPHRIS at DailyMed |
Recent Clinical Trials for SAPHRIS
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 |
| University of Louisville | Phase 2 |
Pharmacology for SAPHRIS
| Drug Class | Atypical Antipsychotic |
Paragraph IV (Patent) Challenges for SAPHRIS
| 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 SAPHRIS
| 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 | 022117-001 | Aug 13, 2009 | 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 | ||
| Allergan | SAPHRIS | asenapine maleate | TABLET;SUBLINGUAL | 022117-001 | Aug 13, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Allergan | SAPHRIS | asenapine maleate | TABLET;SUBLINGUAL | 022117-002 | Aug 13, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Allergan | SAPHRIS | asenapine maleate | TABLET;SUBLINGUAL | 022117-002 | Aug 13, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 SAPHRIS
| 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 |
International Patents for SAPHRIS
See the table below for patents covering SAPHRIS around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | 225051 | SUBLINGUAL OR BUCCAL PHARMACEUTICAL COMPOSITIONS CONTAINING TRANS-5-CHLORO-2-METHYL-2,3,3A,12B-TETRAHYDRO-1H-DIBENZ[2,3:6,7]OXEPINO[4,5-C]PYRROLE | ⤷ Sign Up |
| Russian Federation | 2139051 | СУБЛИНГВАЛЬНАЯ ИЛИ ТРАНСБУККАЛЬНАЯ ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (SUBLINGUAL OR TRANSBUCCAL PHARMACEUTICAL COMPOSITION) | ⤷ Sign Up |
| Germany | 122010000050 | ⤷ Sign Up | |
| Denmark | 0746317 | ⤷ Sign Up | |
| Austria | 167057 | ⤷ Sign Up | |
| Czech Republic | 9602541 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 9523600 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SAPHRIS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0746317 | C300461 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ASENAPINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET MALEAAT; REGISTRATION NO/DATE: EU/1/10/640/001-006 20100901 |
| 0746317 | 10C0056 | France | ⤷ Sign Up | PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901 |
| 0746317 | SPC/GB10/046 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ASENAPINE; REGISTERED: UK EU/1/10/640/001 20100901; UK EU/1/10/640/002 20100901; UK EU/1/10/640/003 20100901; UK EU/1/10/640/004 20100901; UK EU/1/10/640/005 20100901; UK EU/1/10/640/006 20100901 |
| 0746317 | 122010000050 | Germany | ⤷ Sign Up | PRODUCT NAME: ASENAPINHALTIGES ARZNEIMITTEL; REGISTRATION NO/DATE: EU/1/10/640/001-006 20100901 |
| 0746317 | C00746317/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ASENAPINUM; REGISTRATION NO/DATE: SWISSMEDIC 62073 20.07.2012 |
| 0746317 | SPC032/2010 | Ireland | ⤷ Sign Up | SPC032/2010: 20101210, EXPIRES: 20200228 |
| 0746317 | SZ 39/2010 | Austria | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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