Pharsight

1. Fazaclo Odt patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6106861	JAZZ	Multiparticulate tablet disintegrating in less than 40 seconds in the mouth	Dec, 2017 (6 years ago)
US6024981	JAZZ	Rapidly dissolving robust dosage form	Apr, 2018 (6 years ago)
US6221392	JAZZ	Rapidly dissolving robust dosage form	Apr, 2018 (6 years ago)

Drugs and Companies using CLOZAPINE ingredient

Market Authorisation Date: 30 May, 2007

Treatment: NA

Dosage: TABLET, ORALLY DISINTEGRATING;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
12.5 mg	05 Jun, 2008	1		09 Apr, 2018	Extinguished
25 mg and 100 mg	28 Apr, 2008	1	25 Nov, 2015	09 Apr, 2018	Extinguished
150 mg	08 Apr, 2011	1	25 Nov, 2015	09 Apr, 2018	Deferred
200 mg	18 Apr, 2011	1	25 Nov, 2015	09 Apr, 2018	Deferred

Strength	Dosage	Availability
25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued
100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued
150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued
200MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued
50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued
12.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued

FAZACLO ODT family patents

2. Xywav patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP17200764A	2020-09-11	Ter Meer Steinmeister & Partner Patentanwälte mbB	Granted and Under Opposition
EP17200764A	2020-09-10	Hexal AG	Granted and Under Opposition
EP17200764A	2020-09-02	Zentiva, k.s.	Granted and Under Opposition
EP17200764A	2020-03-16	Hoffman Eitle Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB	Granted and Under Opposition
EP14709858A	2018-08-14	Ter Meer Steinmeister & Partner Patentanwälte mbB	Revoked
EP14709858A	2018-08-14	Hexal AG	Revoked
EP14709858A	2018-07-23	Hoffmann Eitle	Revoked

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9050302	March, 2016	Terminated-Denied	Jazz Pharmaceuticals Ireland Limited	RANBAXY INC
US8772306	February, 2016	Terminated-Denied	Jazz Pharmaceutical, Inc.	Amneal Pharmaceuticals LLC
US8772306	October, 2015	Terminated-Settled	Jazz Pharmaceutical, Inc.	Ranbaxy, Inc.
US8772306	October, 2015	Terminated-Denied	Jazz Pharmaceutical, Inc.	Par Pharmaceutical, Inc.
US8731963	September, 2015	Final Written Decision	Jazz Pharmaceuticals, Inc.	Par Pharmaceutical, Inc. et al.

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8731963	JAZZ	Sensitive drug distribution system and method	Dec, 2022 (1 year, 4 months ago)
US8731963 (Pediatric)	JAZZ	Sensitive drug distribution system and method	Jun, 2023 (10 months ago)
US10195168	JAZZ	Gamma-hydroxybutyrate compositions and their uses for the treatment of disorders	Jan, 2033 (8 years from now)
US8591922	JAZZ	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders	Jan, 2033 (8 years from now)
US9132107	JAZZ	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders	Jan, 2033 (8 years from now)
US11554102	JAZZ	Gamma-hydroxybutyrate compositions and their uses for the treatment of disorders	Jan, 2033 (8 years from now)
US10675258	JAZZ	Method of using gamma-hydroxybutyrate compositions for the treatment of disorders	Jan, 2033 (8 years from now)
US8901173	JAZZ	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders	Jan, 2033 (8 years from now)
US9486426	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (8 years from now)
US10213400	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (8 years from now)
US8772306	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (8 years from now)
US11253494	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (8 years from now)
US10864181	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (8 years from now)
US9050302	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Mar, 2033 (8 years from now)
US10864181 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (9 years from now)
US9486426 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (9 years from now)
US8772306 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (9 years from now)
US10213400 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (9 years from now)
US11253494 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (9 years from now)
US9050302 (Pediatric)	JAZZ	Method of administration of gamma hydroxybutyrate with monocarboxylate transporters	Sep, 2033 (9 years from now)
US11426373	JAZZ	Gamma-hydroxybutyrate compositions and their use for the treatment of disorders	Sep, 2037 (13 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-361)	Jul 21, 2027
New Indication(I-870)	Aug 12, 2024
Orphan Drug Exclusivity(ODE-369)	Aug 12, 2028
Orphan Drug Exclusivity(ODE-231)	Jul 21, 2027
New Product(NP)	Jul 21, 2023

Drugs and Companies using CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE ingredient

Market Authorisation Date: 21 July, 2020

Treatment: Method of treating a patient with a prescription drug using a computer database in a computer system for distribution; Treatment of cataplexy or excessive daytime sleepiness (eds) in patients 7 years ...

Dosage: SOLUTION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.234 g/0.096 g/ 013 g/0.04 g per mL	12 Apr, 2021	1		15 Mar, 2033

Strength	Dosage	Availability
0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML	SOLUTION;ORAL	Prescription

XYWAV family patents

3. Zepzelca 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.
US7763615	JAZZ	Ecteinascidin analogs for use as antitumour agents	Dec, 2029 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jun 15, 2025
Orphan Drug Exclusivity(ODE-304)	Jun 15, 2027

Drugs and Companies using LURBINECTEDIN ingredient

NCE-1 date: 15 June, 2024

Market Authorisation Date: 15 June, 2020

Treatment: Treatment of adult patients with small cell lung cancer (sclc) with disease progression on or after platinum-based chemotherapy.

Dosage: POWDER;INTRAVENOUS

Pharsight

Jazz patents expiration

1. Fazaclo Odt patents expiration

FAZACLO ODT family patents

2. Xywav patents expiration

XYWAV family patents

3. Zepzelca patents expiration

ZEPZELCA family patents

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