Pharsight

1. List of Ermeza drug patents

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Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9345772	MYLAN	Liquid levothyroxine formulations	Feb, 2035 (11 years from now)

Market Authorisation Date: 29 April, 2022

Treatment: NA

Dosage: SOLUTION;ORAL

Strength	Dosage	Availability
150MCG/5ML	SOLUTION;ORAL	Prescription

2. List of Levolet drug patents

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Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10406108	GENUS LIFESCIENCES	Thyroid hormone oral dosage forms and methods of using the same	Mar, 2038 (14 years from now)
US10231931	GENUS LIFESCIENCES	Thyroid hormone oral dosage forms and methods of using the same	Mar, 2038 (14 years from now)

Market Authorisation Date: 06 June, 2003

Treatment: NA

Dosage: TABLET;ORAL

Strength	Dosage	Availability
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription

3. List of Levothyroxine Sodium drug patents

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
US9006289	January, 2017	Terminated-Settled	Fresenius Kabi USA, LLC	Mylan Institutional Inc.
US9168238	January, 2017	Terminated-Settled	Fresenius Kabi USA, LLC	Mylan Institutional Inc.
US9168239	January, 2017	Terminated-Settled	Fresenius Kabi USA LLC	Mylan Institutional Inc.

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Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9168239	FRESENIUS KABI USA	Levothyroxine formulations	Aug, 2032 (9 years from now)
US9168238	FRESENIUS KABI USA	Levothyroxine formulations	Aug, 2032 (9 years from now)
US9006289	FRESENIUS KABI USA	Levothyroxine formulations	Oct, 2032 (9 years from now)
US11135190	FRESENIUS KABI USA	Levothyroxine liquid formulations	Dec, 2036 (13 years from now)
US9782376	FRESENIUS KABI USA	Levothyroxine liquid formulations	Dec, 2036 (13 years from now)
US10398669	FRESENIUS KABI USA	Levothyroxine liquid formulations	Dec, 2036 (13 years from now)

Market Authorisation Date: 24 June, 2011

Treatment: NA

Dosage: POWDER;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mcg/vial and 500 mcg/vial	14 Apr, 2015	2	29 Jun, 2016	03 Oct, 2032	Eligible
200 mcg/vial	01 May, 2015	1	07 Dec, 2015	03 Oct, 2032	Deferred

Strength	Dosage	Availability
100MCG/VIAL	POWDER;INTRAVENOUS	Prescription
200MCG/VIAL	POWDER;INTRAVENOUS	Prescription
500MCG/VIAL	POWDER;INTRAVENOUS	Prescription

LEVOTHYROXINE SODIUM family patents

United States

Canada

European Union

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4. List of Levothyroxine Sodium drug patents

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Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US11154498	CUSTOPHARM INC	Stabilized liquid formulation of levothyroxine	Jul, 2036 (13 years from now)

Market Authorisation Date: 17 May, 2021

Treatment: NA

Dosage: SOLUTION;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
100 mcg/vial and 500 mcg/vial	14 Apr, 2015	2	29 Jun, 2016	03 Oct, 2032	Eligible
200 mcg/vial	01 May, 2015	1	07 Dec, 2015	03 Oct, 2032	Deferred

Strength	Dosage	Availability
100MCG/ML	SOLUTION;INTRAVENOUS	Prescription

LEVOTHYROXINE SODIUM family patents

United States

India

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5. List of Levoxyl drug patents

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Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7067148	KING PHARMS	Stabilized pharmaceutical and thyroid hormone compositions and method of preparation	Feb, 2022 (1 year, 3 months ago)
US6555581	KING PHARMS	Levothyroxine compositions and methods	Feb, 2022 (1 year, 3 months ago)
US7101569	KING PHARMS	Methods of administering levothyroxine pharmaceutical compositions	Oct, 2023 (3 months from now)

Market Authorisation Date: 25 May, 2001

Treatment: Method of use of administering levothyroxine

Dosage: TABLET;ORAL

Strength	Dosage	Availability
0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium	TABLET;ORAL	Prescription
0.3MG	TABLET;ORAL	Discontinued

LEVOXYL family patents

United States

Australia

Canada

Mexico

Brazil

Norway

Japan

European Union

Korea, Republic of

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6. List of Thyquidity drug patents

Application	Filing Date	Opposition Party	Legal Status
EP11711688A	2016-07-11	Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.	Granted and Under Opposition

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Patent Number	Company	Patent Title	Patent Expiry	Activity Alert
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9050307	VISTAPHARM	Method for the preparation of a levothyroxine solution	Aug, 2031 (8 years from now)

Market Authorisation Date: 30 November, 2020

Treatment: NA

Dosage: SOLUTION;ORAL

Strength	Dosage	Availability
100MCG/5ML	SOLUTION;ORAL	Prescription

THYQUIDITY family patents

Cyprus

Denmark

Croatia

Poland

United States

Hungary

Slovenia

Portugal

Spain

European Union

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7. List of Tirosint drug patents

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Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7691411	INSTITUT BIOCHIMIQUE	Pharmaceutical formulae for thyroid hormones and procedures for obtaining them	Mar, 2024 (9 months from now)
US7723390	INSTITUT BIOCHIMIQUE	Pharmaceutical formulations for thyroid hormones	Mar, 2024 (9 months from now)

Market Authorisation Date: 13 October, 2006

Treatment: NA

Dosage: CAPSULE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
75 mcg and 150 mcg	29 Dec, 2017	1	28 Oct, 2020	14 Mar, 2024	Deferred
88 mcg, 100 mcg and 125 mcg	01 Aug, 2019	1	06 Jan, 2021	14 Mar, 2024	Eligible
112 mcg	18 Dec, 2020	1	16 Apr, 2021	14 Mar, 2024	Eligible
200 mcg	30 Dec, 2021	1	09 Nov, 2022	14 Mar, 2024	Eligible
137 mcg and 175 mcg	04 Nov, 2022	1		14 Mar, 2024

Strength	Dosage	Availability
0.013MG	CAPSULE;ORAL	Prescription
0.025MG	CAPSULE;ORAL	Prescription
0.05MG	CAPSULE;ORAL	Prescription
0.075MG	CAPSULE;ORAL	Prescription
0.088MG	CAPSULE;ORAL	Prescription
0.1MG	CAPSULE;ORAL	Prescription
0.112MG	CAPSULE;ORAL	Prescription
0.125MG	CAPSULE;ORAL	Prescription
0.137MG	CAPSULE;ORAL	Prescription
0.15MG	CAPSULE;ORAL	Prescription
0.175MG	CAPSULE;ORAL	Prescription
0.200MG	CAPSULE;ORAL	Prescription

TIROSINT family patents

Denmark

Italy

United States

Canada

Austria

Spain

Germany

Japan

European Union

Slovenia

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8. List of Tirosint-sol drug patents

Application	Filing Date	Opposition Party	Legal Status
EP17794903A	2021-04-21	Uni-Pharma Kleon Tsetis Pharmaceutical Laboratories S.A.	Granted and Under Opposition

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Patent Number	Company	Patent Title	Patent Expiry
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10537538	INSTITUT BIOCHIMIQUE	High-stability packaged solutions of T4 thyroid hormone	Feb, 2037 (13 years from now)
US11096913	INSTITUT BIOCHIMIQUE	High-stability packaged solutions of T4 thyroid hormone	Feb, 2037 (13 years from now)

Market Authorisation Date: 15 December, 2016

Treatment: NA

Dosage: SOLUTION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
13 mcg/mL 25 mcg/mL 50 mcg/mL 75 mcg/mL 88 mcg/mL 100 mcg/mL 112 mcg/mL 125 mcg/mL 137 mcg/mL 150 mcg/mL 175 mcg/mL 200 mcg/mL	30 Sep, 2022	1		28 Feb, 2037

Strength	Dosage	Availability
13MCG/ML	SOLUTION;ORAL	Prescription
25MCG/ML	SOLUTION;ORAL	Prescription
37.5MCG/ML	SOLUTION;ORAL	Prescription
44MCG/ML	SOLUTION;ORAL	Prescription
50MCG/ML	SOLUTION;ORAL	Prescription
62.5MCG/ML	SOLUTION;ORAL	Prescription
75MCG/ML	SOLUTION;ORAL	Prescription
88MCG/ML	SOLUTION;ORAL	Prescription
100MCG/ML	SOLUTION;ORAL	Prescription
112MCG/ML	SOLUTION;ORAL	Prescription
125MCG/ML	SOLUTION;ORAL	Prescription
137MCG/ML	SOLUTION;ORAL	Prescription
150MCG/ML	SOLUTION;ORAL	Prescription
175MCG/ML	SOLUTION;ORAL	Prescription
200MCG/ML	SOLUTION;ORAL	Prescription