Time limited offer for new users ▶ Get up to 3 months free

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Baxter
Medtronic
Mallinckrodt
Dow

Last Updated: February 2, 2023

Asenapine - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


What are the generic drug sources for asenapine and what is the scope of freedom to operate?

Asenapine is the generic ingredient in three branded drugs marketed by Hisamitsu, Alembic Pharms Ltd, Breckenridge, Sigmapharm Labs Llc, and Allergan, and is included in five NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Asenapine has thirty-eight patent family members in nine countries.

There are twelve drug master file entries for asenapine. One supplier is listed for this compound.

Summary for asenapine
International Patents:38
US Patents:7
Tradenames:3
Applicants:5
NDAs:5
Drug Master File Entries: 12
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 80
Clinical Trials: 55
Patent Applications: 4,891
Drug Prices: Drug price trends for asenapine
What excipients (inactive ingredients) are in asenapine?asenapine excipients list
DailyMed Link:asenapine at DailyMed
Drug Prices for asenapine

See drug prices for asenapine

Recent Clinical Trials for asenapine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Lindner Center of HOPEPhase 2
National Alliance on Mental Illness New Mexico
Montana State University

See all asenapine clinical trials

Pharmacology 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
Breckenridge ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 205960-001 Dec 10, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-002 Oct 11, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-003 Oct 11, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-002 Oct 11, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Hisamitsu SECUADO asenapine SYSTEM;TRANSDERMAL 212268-001 Oct 11, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Alembic Pharms Ltd ASENAPINE MALEATE asenapine maleate TABLET;SUBLINGUAL 206098-002 Dec 10, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Allergan SAPHRIS asenapine maleate TABLET;SUBLINGUAL 022117-003 Mar 12, 2015 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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/001177
Sycrest 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

International Patents for asenapine

Country Patent Number Title Estimated Expiration
Taiwan 201410272 See Plans and Pricing
Poland 2878299 See Plans and Pricing
Japan 6005742 See Plans and Pricing
Spain 2632946 See Plans and Pricing
European Patent Office 2878299 TIMBRE ADHÉSIF (ADHESIVE PATCH) See Plans and Pricing
China 104487071 See Plans and Pricing
Taiwan I603748 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for asenapine

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0746317 C300461 Netherlands See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: ASENAPINE; REGISTRATION NO/DATE: EU/1/10/640/001 20100901
0746317 SPC/GB10/046 United Kingdom See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Merck
AstraZeneca
Boehringer Ingelheim
McKinsey
Johnson and Johnson

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.