Pharsight

1. Cequa 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).
US10441630	SUN PHARM	Topical formulations and uses thereof	Aug, 2033 (9 years from now)
US8980839	SUN PHARM	Topical aqueous nanomicellar, ophthalmic solutions and uses thereof	Aug, 2033 (9 years from now)
US9937225	SUN PHARM	Topical formulations and uses thereof	Aug, 2033 (9 years from now)
US10918694	SUN PHARM	Topical cyclosporine-containing formulations and uses thereof	Feb, 2037 (12 years from now)

Market Authorisation Date: 14 August, 2018

Treatment: Increase tear production in patients with keratoconjunctivitis sicca (dry eye).

Dosage: SOLUTION;OPHTHALMIC

Strength	Dosage	Availability
0.09%	SOLUTION;OPHTHALMIC	Prescription

CEQUA family patents

2. Neoral 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).
US5985321	NOVARTIS	Soft gelatin capsule manufacture	Sep, 2014 (9 years ago)

Market Authorisation Date: 14 July, 1995

Treatment: NA

Dosage: SOLUTION;ORAL; CAPSULE;ORAL

Strength	Dosage	Availability
100MG/ML	SOLUTION;ORAL	Prescription
100MG	CAPSULE;ORAL	Prescription
50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE;ORAL	Discontinued
25MG	CAPSULE;ORAL	Prescription

NEORAL family patents

3. Restasis patents expiration

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9248191	January, 2017	Terminated-Settled	Allergan, Inc.	Famy Care Limited
US8642556	January, 2017	FWD Entered	Allergan, Inc.	Teva Pharmaceuticals USA, Inc.
US8642556	January, 2017	Terminated-Settled	Allergan, Inc.	Famy Care Limited
US9248191	January, 2017	Terminated-Dismissed	Allergan, Inc.	Akorn, Inc.
US8629111	January, 2017	Terminated-Dismissed	Allergan, Inc.	Akorn, Inc.
US8629111	January, 2017	Terminated-Settled	Allergan, Inc.	Famy Care Limited
US8642556	January, 2017	FWD Entered	Allergan, Inc.	Akorn, Inc.
US8633162	January, 2017	FWD Entered	Allergan, Inc.	Teva Pharmaceuticals USA, Inc.
US9248191	January, 2017	Terminated-Dismissed	Allergan, Inc.	Teva Pharmaceuticals USA, Inc.
US8685930	January, 2017	Terminated-Dismissed	Allergan, Inc.	Teva Pharmaceuticals USA, Inc.
US8633162	January, 2017	FWD Entered	Allergan, Inc.	Akorn, Inc.
US8629111	January, 2017	Terminated-Dismissed	Allergan, Inc.	Teva Pharmaceuticals USA, Inc.
US8648048	January, 2017	Terminated-Dismissed	Allergan, Inc.	Teva Pharmaceuticals USA, Inc.
US8685930	January, 2017	Terminated-Settled	Allergan, Inc.	Famy Care Limited
US8648048	January, 2017	Terminated-Dismissed	Allergan, Inc.	Akorn, Inc.
US8648048	January, 2017	Terminated-Settled	Allergan, Inc.	Famy Care Limited
US8633162	January, 2017	Terminated-Settled	Allergan, Inc.	Famy Care Limited
US8685930	January, 2017	Terminated-Dismissed	Allergan, Inc.	Akorn, Inc.
US8629111	June, 2016	Terminated-Settled	Allergan, Inc.	Argentum Pharmaceuticals LLC
US8685930	June, 2016	Terminated-Dismissed	Allergan, Inc.	Mylan Pharmaceuticals Inc.
US8642556	June, 2016	FWD Entered	Allergan, Inc.	Mylan Pharmaceuticals Inc.
US8633162	June, 2016	FWD Entered	Allergan, Inc.	Mylan Pharmaceuticals Inc.
US8648048	June, 2016	Terminated-Dismissed	Allergan, Inc.	Mylan Pharmaceuticals Inc.
US9248191	June, 2016	Terminated-Dismissed	Allergan, Inc.	Mylan Pharmaceuticals Inc.
US8629111	June, 2016	Terminated-Dismissed	Allergan, Inc.	Mylan Pharmaceuticals Inc.
US8685930	June, 2015	Terminated-Denied	Allergan, Inc.	Apotex Corp.
US8633162	June, 2015	Terminated-Denied	Allergan, Inc.	Apotex Corp.
US8642556	June, 2015	Terminated-Denied	Allergan, Inc.	Apotex Corp.
US8648048	June, 2015	Terminated-Denied	Allergan, Inc.	Apotex Corp.
US8629111	June, 2015	Terminated-Denied	Allergan, Inc.	Apotex Corp.

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).
US5474979	ABBVIE	Nonirritating emulsions for sensitive tissue	May, 2014 (9 years ago)
US8685930	ABBVIE	Methods of providing therapeutic effects using cyclosporin components	Aug, 2024 (4 months from now)
US8633162	ABBVIE	Methods of providing therapeutic effects using cyclosporin components	Aug, 2024 (4 months from now)
US8648048	ABBVIE	Methods of providing therapeutic effects using cyclosporin components	Aug, 2024 (4 months from now)
US9248191	ABBVIE	Methods of providing therapeutic effects using cyclosporin components	Aug, 2024 (4 months from now)
US8642556	ABBVIE	Methods of providing therapeutic effects using cyclosporin components	Aug, 2024 (4 months from now)
US8629111	ABBVIE	Methods of providing therapeutic effects using cyclosporin components	Aug, 2024 (4 months from now)

Market Authorisation Date: 23 December, 2002

Treatment: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye).; Increase tear production in patients with keratoconjunctivitis sicca (dry eye).

Dosage: EMULSION;OPHTHALMIC

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.0005	13 Jan, 2014	1		17 May, 2014	Extinguished

Strength	Dosage	Availability
0.05%	EMULSION;OPHTHALMIC	Prescription

RESTASIS family patents

4. Restasis Multidose patents expiration

Application	Filing Date	Opposition Party	Legal Status

EP14815668A	2018-10-30	Epping Hermann Fischer Patentanwaltgesellschaft MBH	Patent maintained as amended

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US9248191	January, 2017	Terminated-Settled	Allergan, Inc.	Famy Care Limited
US8642556	January, 2017	FWD Entered	Allergan, Inc.	Teva Pharmaceuticals USA, Inc.
US8642556	January, 2017	Terminated-Settled	Allergan, Inc.	Famy Care Limited
US9248191	January, 2017	Terminated-Dismissed	Allergan, Inc.	Akorn, Inc.
US8629111	January, 2017	Terminated-Dismissed	Allergan, Inc.	Akorn, Inc.
US8629111	January, 2017	Terminated-Settled	Allergan, Inc.	Famy Care Limited
US8642556	January, 2017	FWD Entered	Allergan, Inc.	Akorn, Inc.
US8633162	January, 2017	FWD Entered	Allergan, Inc.	Teva Pharmaceuticals USA, Inc.
US9248191	January, 2017	Terminated-Dismissed	Allergan, Inc.	Teva Pharmaceuticals USA, Inc.
US8685930	January, 2017	Terminated-Dismissed	Allergan, Inc.	Teva Pharmaceuticals USA, Inc.
US8633162	January, 2017	FWD Entered	Allergan, Inc.	Akorn, Inc.
US8629111	January, 2017	Terminated-Dismissed	Allergan, Inc.	Teva Pharmaceuticals USA, Inc.
US8648048	January, 2017	Terminated-Dismissed	Allergan, Inc.	Teva Pharmaceuticals USA, Inc.
US8685930	January, 2017	Terminated-Settled	Allergan, Inc.	Famy Care Limited
US8648048	January, 2017	Terminated-Dismissed	Allergan, Inc.	Akorn, Inc.
US8648048	January, 2017	Terminated-Settled	Allergan, Inc.	Famy Care Limited
US8633162	January, 2017	Terminated-Settled	Allergan, Inc.	Famy Care Limited
US8685930	January, 2017	Terminated-Dismissed	Allergan, Inc.	Akorn, Inc.
US8629111	June, 2016	Terminated-Settled	Allergan, Inc.	Argentum Pharmaceuticals LLC
US8685930	June, 2016	Terminated-Dismissed	Allergan, Inc.	Mylan Pharmaceuticals Inc.
US8642556	June, 2016	FWD Entered	Allergan, Inc.	Mylan Pharmaceuticals Inc.
US8633162	June, 2016	FWD Entered	Allergan, Inc.	Mylan Pharmaceuticals Inc.
US8648048	June, 2016	Terminated-Dismissed	Allergan, Inc.	Mylan Pharmaceuticals Inc.
US9248191	June, 2016	Terminated-Dismissed	Allergan, Inc.	Mylan Pharmaceuticals Inc.
US8629111	June, 2016	Terminated-Dismissed	Allergan, Inc.	Mylan Pharmaceuticals Inc.
US8685930	June, 2015	Terminated-Denied	Allergan, Inc.	Apotex Corp.
US8633162	June, 2015	Terminated-Denied	Allergan, Inc.	Apotex Corp.
US8642556	June, 2015	Terminated-Denied	Allergan, Inc.	Apotex Corp.
US8648048	June, 2015	Terminated-Denied	Allergan, Inc.	Apotex Corp.
US8629111	June, 2015	Terminated-Denied	Allergan, Inc.	Apotex Corp.

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).
US8648048	ABBVIE	Methods of providing therapeutic effects using cyclosporin components	Aug, 2024 (4 months from now)
US8629111	ABBVIE	Methods of providing therapeutic effects using cyclosporin components	Aug, 2024 (4 months from now)
US8685930	ABBVIE	Methods of providing therapeutic effects using cyclosporin components	Aug, 2024 (4 months from now)
US8633162	ABBVIE	Methods of providing therapeutic effects using cyclosporin components	Aug, 2024 (4 months from now)
US9248191	ABBVIE	Methods of providing therapeutic effects using cyclosporin components	Aug, 2024 (4 months from now)
US8642556	ABBVIE	Methods of providing therapeutic effects using cyclosporin components	Aug, 2024 (4 months from now)
US8292129	ABBVIE	Dispensing device	Feb, 2031 (6 years from now)
US8561859	ABBVIE	Dispensing device	Apr, 2032 (7 years from now)
US9676525	ABBVIE	Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids	Feb, 2034 (9 years from now)
US9669974	ABBVIE	Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids	May, 2034 (10 years from now)

Market Authorisation Date: 23 December, 2002

Treatment: Increase tear production in patients with keratoconjunctivitis sicca (dry eye).; Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye).

Dosage: EMULSION;OPHTHALMIC

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.0005	13 Jan, 2014	1		17 May, 2014	Extinguished

Strength	Dosage	Availability
0.05%	EMULSION;OPHTHALMIC	Prescription

RESTASIS MULTIDOSE family patents

5. Verkazia 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).
US8524779	HARROW EYE	Emulsion compositions containing quaternary ammonium compounds	Jan, 2026 (1 year, 9 months from now)
US11612658	HARROW EYE	Oil-in-water emulsions comprising cetalkonium chloride and methods of making and using the same	Jan, 2026 (1 year, 9 months from now)
US9956289	HARROW EYE	Emulsion compositions containing quaternary ammonium compounds	Jan, 2026 (1 year, 9 months from now)
US7973081	HARROW EYE	Emulsion compositions containing quaternary ammonium compounds	Jan, 2026 (1 year, 9 months from now)
US9220694	HARROW EYE	Emulsion compositions containing cetalkonium chloride	Jan, 2026 (1 year, 9 months from now)
US8298568	HARROW EYE	Oil-in-water type emulsion with low concentration of cationic agent and positive zeta potential	Nov, 2027 (3 years from now)
US9132071	HARROW EYE	Compositions containing quaternary ammonium compounds	Jun, 2029 (5 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-358)	Jun 23, 2028
New Product(NP)	Jun 23, 2024

Market Authorisation Date: 23 June, 2021

Treatment: For the treatment of vernal keratoconjunctivitis in children and adults

Dosage: EMULSION;OPHTHALMIC

Strength	Dosage	Availability
0.1%	EMULSION;OPHTHALMIC	Prescription

VERKAZIA family patents

6. Vevye 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).
US8614178	HARROW EYE	Pharmaceutical composition for treatment of dry eye syndrome	Dec, 2030 (6 years from now)
US10813976	HARROW EYE	Ophthalmic compositions comprising ciclosporin	Sep, 2037 (13 years from now)
US11154513	HARROW EYE	Semifluorinated compounds	Nov, 2038 (14 years from now)
US11413323	HARROW EYE	Ophthalmic composition for treatment of dry eye disease	Oct, 2039 (15 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	May 30, 2026

Market Authorisation Date: 30 May, 2023

Treatment: Treatment of the signs and symptoms of dry eye disease (ded); Treatment of dry eye disease (ded)

Dosage: SOLUTION;OPHTHALMIC

Pharsight

Drugs that contain Cyclosporine

1. Cequa patents expiration

CEQUA family patents

2. Neoral patents expiration

NEORAL family patents

3. Restasis patents expiration

RESTASIS family patents

4. Restasis Multidose patents expiration

RESTASIS MULTIDOSE family patents

5. Verkazia patents expiration

VERKAZIA family patents

6. Vevye patents expiration

VEVYE family patents

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