Pharsight

Saphris patents expiration

Drug Patent Number Company Drug Patent Title Drug Patent Expiry Activity Alert
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7741358 ALLERGAN Crystal form of asenapine maleate
Apr, 2026

(1 year, 11 months from now)

US8022228 ALLERGAN Crystal form of asenapine maleate
Apr, 2026

(1 year, 11 months from now)

These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5763476 ALLERGAN Sublingual or buccal pharmaceutical composition
Jun, 2020

(3 years ago)

US5763476

(Pediatric)

ALLERGAN Sublingual or buccal pharmaceutical composition
Dec, 2020

(3 years ago)

US8022228

(Pediatric)

ALLERGAN Crystal form of asenapine maleate
Oct, 2026

(2 years from now)

US7741358

(Pediatric)

ALLERGAN Crystal form of asenapine maleate
Oct, 2026

(2 years from now)

Saphris is owned by Allergan.

Saphris contains Asenapine Maleate.

Saphris has a total of 6 drug patents out of which 2 drug patents have expired.

Expired drug patents of Saphris are:

  • US5763476
  • US5763476*PED

Saphris was authorised for market use on 12 March, 2015.

Saphris is available in tablet;sublingual dosage forms.

Saphris can be used as use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: as adjunctive treatment to lithium or valproate in adults, method of treating schizophrenia and bipolar disorder.

Drug patent challenges can be filed against Saphris from 12 September, 2017.

The generics of Saphris are possible to be released after 06 October, 2026.

Drug Exclusivity Drug Exclusivity Expiration
New Patient Population(NPP) Mar 12, 2018
M(M-158) Mar 12, 2018
New Dosing Schedule(D-166) Jan 13, 2020
New Indication(I-597) Jan 13, 2020
Pediatric Exclusivity(PED) Sep 12, 2018
New Chemical Entity Exclusivity(NCE) Aug 13, 2014
New Indication(I-629) Sep 03, 2013
New Indication(I-628) Sep 03, 2013

Drugs and Companies using ASENAPINE MALEATE ingredient

NCE-1 date: 12 September, 2017

Market Authorisation Date: 12 March, 2015

Treatment: Method of treating schizophrenia and bipolar disorder; Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: as adjunctive treatment to lithium or...

Dosage: TABLET;SUBLINGUAL

How can I launch a generic of SAPHRIS before it's drug patent expiration?
More Information on Dosage

SAPHRIS family patents

Family Patents