SAPHRIS Drug Patent Profile

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 10^th, 2020.

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:	87
Formulation / Manufacturing:	see details
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

See drug prices for SAPHRIS

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

See all SAPHRIS clinical trials

Pharmacology for SAPHRIS

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for SAPHRIS

N05AH	Diazepines, oxazepines, thiazepines and oxepines
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

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					Y
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-001	Aug 13, 2009	AB	RX	Yes	No					Y
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-003	Mar 12, 2015	AB	RX	Yes	No					Y
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-001	Aug 13, 2009	AB	RX	Yes	No					Y

Expired US Patents for SAPHRIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-001	Aug 13, 2009
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-003	Mar 12, 2015
Allergan	SAPHRIS	asenapine maleate	TABLET;SUBLINGUAL	022117-002	Aug 13, 2009

International Patents for SAPHRIS

See the table below for patents covering SAPHRIS around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0746317	COMPOSITION PHARMACEUTIQUE SUBLINGUALE OU BUCCALE (SUBLINGUAL OR BUCCAL PHARMACEUTICAL COMPOSITION)
Germany	69502939
Japan	H09509674
Hungary	T76319

Supplementary Protection Certificates for SAPHRIS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0746317	SPC032/2010	Ireland		SPC032/2010: 20101210, EXPIRES: 20200228
0746317	122010000050	Germany		PRODUCT NAME: ASENAPINHALTIGES ARZNEIMITTEL; REGISTRATION NO/DATE: EU/1/10/640/001-006 20100901
0746317	91751	Luxembourg		91751, EXPIRES: 20200301
0746317	SZ 39/2010	Austria