Pharsight

1. Alocril patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
USRE38628	ALLERGAN	Pharmaceutical compositions	Aug, 2012 (11 years ago)

Drugs and Companies using NEDOCROMIL SODIUM ingredient

Market Authorisation Date: 08 December, 1999

Treatment: A method of treatment of a condition involving an antibody antigen reaction

Dosage: SOLUTION/DROPS;OPHTHALMIC

Strength	Dosage	Availability
2%	SOLUTION/DROPS;OPHTHALMIC	Discontinued

ALOCRIL family patents

2. Avycaz patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP17182561A	2019-11-26	Lederer & Keller Patentanwälte Partnerschaft mbB	Patent maintained as amended

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US8178554	ALLERGAN	Heterocyclic compounds, their preparation and their use as medicaments, in particular as anti-bacterial agents	Jul, 2021 (2 years ago)
US7112592	ALLERGAN	Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents	Jan, 2026 (1 year, 8 months from now)
US8471025	ALLERGAN	Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt	Aug, 2031 (7 years from now)
US9695122	ALLERGAN	Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof	Jun, 2032 (8 years from now)
US8969566	ALLERGAN	Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof	Jun, 2032 (8 years from now)
US9284314	ALLERGAN	Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof	Jun, 2032 (8 years from now)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7612087	ALLERGAN	Heterocyclic compounds as inhibitors of beta-lactamases	Nov, 2026 (2 years from now)
US8835455	ALLERGAN	Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt	Oct, 2030 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Feb 25, 2020
New Patient Population(NPP)	Dec 20, 2025
Generating Antibiotic Incentives Now(GAIN)	Feb 25, 2025
New Indication(I-738)	Jun 22, 2019

Drugs and Companies using AVIBACTAM SODIUM; CEFTAZIDIME ingredient

NCE-1 date: 26 February, 2024

Market Authorisation Date: 25 February, 2015

Treatment: A method of treating a bacterial infection in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (habp/vabp) patients comprising administering an effective amount of a...

Dosage: POWDER;INTRAVENOUS

Strength	Dosage	Availability
EQ 0.5GM BASE;2GM/VIAL	POWDER;INTRAVENOUS	Prescription

AVYCAZ family patents

3. Bystolic 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).
US5759580	ALLERGAN	Compositions containing micronized nebivolol	Jun, 2015 (8 years ago)
US6545040	ALLERGAN	Method of lowering the blood pressure	Dec, 2021 (2 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Dec 17, 2012

Drugs and Companies using NEBIVOLOL HYDROCHLORIDE ingredient

NCE-1 date: 18 December, 2011

Market Authorisation Date: 17 December, 2007

Treatment: Treatment of hypertension

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
2.5 mg, 5 mg, 10 mg, and 20 mg	19 Dec, 2011	7	16 Apr, 2015	17 Dec, 2021	Eligible

Strength	Dosage	Availability
EQ 5MG BASE	TABLET;ORAL	Prescription
EQ 20MG BASE	TABLET;ORAL	Prescription
EQ 2.5MG BASE	TABLET;ORAL	Prescription
EQ 10MG BASE	TABLET;ORAL	Prescription

BYSTOLIC family patents

4. Crinone patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry	Activity Alert
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5543150	ALLERGAN	Method of progesterone delivery and affect thereof	Sep, 2013 (10 years ago)

Drugs and Companies using PROGESTERONE ingredient

Market Authorisation Date: 31 July, 1997

Treatment: Vaginal administration of progesterone using specified formulation

Dosage: GEL;VAGINAL

Strength	Dosage	Availability
4%	GEL;VAGINAL	Prescription
8%	GEL;VAGINAL	Prescription

CRINONE family patents

5. Gelnique 3% 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).
US7029694	ALLERGAN	Compositions and methods for transdermal oxybutynin therapy	Apr, 2020 (3 years ago)
US7179483	ALLERGAN	Compositions and methods for transdermal oxybutynin therapy	Apr, 2020 (3 years ago)
US8241662	ALLERGAN	Unoccluded topical oxybutynin gel composition and methods for transdermal oxybutynin therapy	Apr, 2020 (3 years ago)
US7198801	ALLERGAN	Formulations for transdermal or transmucosal application	Jun, 2022 (1 year, 9 months ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Dec 07, 2014

Drugs and Companies using OXYBUTYNIN ingredient

Market Authorisation Date: 07 December, 2011

Treatment: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence

Dosage: GEL, METERED;TRANSDERMAL

Strength	Dosage	Availability
3%	GEL, METERED;TRANSDERMAL	Discontinued

GELNIQUE 3% family patents

6. Namenda 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).
US5061703	ALLERGAN	Adamantane derivatives in the prevention and treatment of cerebral ischemia	Apr, 2015 (9 years ago)
US5061703 (Pediatric)	ALLERGAN	Adamantane derivatives in the prevention and treatment of cerebral ischemia	Oct, 2015 (8 years ago)

Drugs and Companies using MEMANTINE HYDROCHLORIDE ingredient

Market Authorisation Date: 18 April, 2005

Treatment: Treatment of moderate to severe dementia of the alzheimer's type

Dosage: SOLUTION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg and 10 mg	16 Oct, 2007	14	30 Jan, 2015	11 Apr, 2015	Eligible

Strength	Dosage	Availability
2MG/ML	SOLUTION;ORAL	Discontinued

NAMENDA family patents

7. Oxytrol patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US7179483	ALLERGAN	Compositions and methods for transdermal oxybutynin therapy	Apr, 2020 (3 years ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5601839	ALLERGAN	Triacetin as a penetration enhancer for transdermal delivery of a basic drug	Apr, 2015 (8 years ago)
US5834010	ALLERGAN	Triacetin as a penetration enhancer for transdermal delivery of a basic drug	Apr, 2015 (8 years ago)
US6743441	ALLERGAN	Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy	Apr, 2020 (3 years ago)
US7081249	ALLERGAN	Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy	Apr, 2020 (3 years ago)
US7081250	ALLERGAN	Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy	Apr, 2020 (3 years ago)
US7081251	ALLERGAN	Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy	Apr, 2020 (3 years ago)
US7081252	ALLERGAN	Compositions and methods for minimizing adverse drug experiences associated with oxybutynin therapy	Apr, 2020 (3 years ago)

Drugs and Companies using OXYBUTYNIN ingredient

Market Authorisation Date: 26 February, 2003

Treatment: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence

Dosage: FILM, EXTENDED RELEASE;TRANSDERMAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
3.9 mg/24 hrs	19 Aug, 2008	1	04 Mar, 2014	26 Apr, 2020	Deferred

Strength	Dosage	Availability
3.9MG/24HR	FILM, EXTENDED RELEASE;TRANSDERMAL	Prescription

OXYTROL family patents

8. Rapaflo patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance.
US5387603	ALLERGAN	1,5,7-trisubstituted indoline compounds and salts thereof	Dec, 2018 (5 years ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5780485	ALLERGAN	Use of α1c specific compounds to treat benign prostatic hyperplasia	Nov, 2012 (11 years ago)
US5403847	ALLERGAN	Use of α1C specific compounds to treat benign prostatic hyperlasia	Nov, 2012 (11 years ago)
US6015819	ALLERGAN	Use of alpha-1C specific compounds to treat benign prostatic hyperplasia	Nov, 2012 (11 years ago)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Oct 08, 2013

Drugs and Companies using SILODOSIN ingredient

NCE-1 date: 08 October, 2012

Market Authorisation Date: 08 October, 2008

Treatment: Use in the treatment of the signs and symptoms of benign prostatic hyperplasia (bph)

Dosage: CAPSULE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
4 mg and 8 mg	09 Oct, 2012	3	31 Mar, 2017	01 Dec, 2018	Deferred

Strength	Dosage	Availability
4MG	CAPSULE;ORAL	Prescription
8MG	CAPSULE;ORAL	Prescription

RAPAFLO family patents

9. Sanctura Xr 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).
US7781449	ALLERGAN	Trospium chloride treatment method	Nov, 2024 (6 months from now)
US7759359	ALLERGAN	Method of treating bladder dysfunction with once-a-day trospium salt formulation	Nov, 2024 (6 months from now)
US7763635	ALLERGAN	Once daily dosage forms of trospium	Nov, 2024 (6 months from now)
US7781448	ALLERGAN	Once daily dosage forms of trospium	Nov, 2024 (6 months from now)
US7410978	ALLERGAN	Once daily dosage forms of trospium	Feb, 2025 (9 months from now)

Drugs and Companies using TROSPIUM CHLORIDE ingredient

Market Authorisation Date: 03 August, 2007

Treatment: Method of treating bladder dysfunction with once a day trospium salt formulation

Dosage: CAPSULE, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
60 mg	02 Mar, 2009	1	12 Oct, 2012	01 Feb, 2025	Deferred

Strength	Dosage	Availability
60MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued

SANCTURA XR family patents

10. Saphris patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
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)

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: maintenance monotherapy in adults

Dosage: TABLET;SUBLINGUAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
5 mg and 10 mg	13 Aug, 2013	4	10 Dec, 2020	06 Apr, 2026	Eligible
2.5 mg	27 Jul, 2017	1	10 Dec, 2020	06 Apr, 2026	Deferred

Strength	Dosage	Availability
EQ 10MG BASE	TABLET;SUBLINGUAL	Prescription
EQ 2.5MG BASE	TABLET;SUBLINGUAL	Prescription
EQ 5MG BASE	TABLET;SUBLINGUAL	Prescription

SAPHRIS family patents

11. Tazorac 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).
US5914334	ALLERGAN	Stable gel formulation for topical treatment of skin conditions	Jun, 2014 (9 years ago)
US6258830	ALLERGAN	Stable gel formulation for topical treatment of skin conditions	Jun, 2014 (9 years ago)

Drugs and Companies using TAZAROTENE ingredient

Market Authorisation Date: 13 June, 1997

Treatment: Stable gel formulation for topical treatment of skin conditions

Dosage: GEL;TOPICAL

Strength	Dosage	Availability
0.05%	GEL;TOPICAL	Prescription
0.1%	GEL;TOPICAL	Prescription

TAZORAC family patents

12. Zymar 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).
US5880283	ALLERGAN	8-alkoxyquinolonecarboxylic acid hydrate with excellent stability and process for producing the same	Dec, 2015 (8 years ago)
US5880283 (Pediatric)	ALLERGAN	8-alkoxyquinolonecarboxylic acid hydrate with excellent stability and process for producing the same	Jun, 2016 (7 years ago)
US6333045	ALLERGAN	Aqueous liquid pharmaceutical composition comprised of gatifloxacin	Aug, 2019 (4 years ago)
US6333045 (Pediatric)	ALLERGAN	Aqueous liquid pharmaceutical composition comprised of gatifloxacin	Feb, 2020 (4 years ago)

Drugs and Companies using GATIFLOXACIN ingredient

Market Authorisation Date: 28 March, 2003

Treatment: NA