Pharsight

1. Colcrys 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).
US8415396	TAKEDA PHARMS USA	Colchine compositions and methods	Oct, 2028 (4 years from now)
US8093297	TAKEDA PHARMS USA	Methods for concomitant administration of colchicine and a second active agent	Oct, 2028 (4 years from now)
US7981938	TAKEDA PHARMS USA	Colchicine compositions and methods	Oct, 2028 (4 years from now)
US7964648	TAKEDA PHARMS USA	Methods for concomitant administration of colchicine and a second active agent	Oct, 2028 (4 years from now)
US7964647	TAKEDA PHARMS USA	Colchicine compositions and methods	Oct, 2028 (4 years from now)
US8093298	TAKEDA PHARMS USA	Methods for concomitant administration of colchicine and macrolide antibiotics	Oct, 2028 (4 years from now)
US8097655	TAKEDA PHARMS USA	Methods for concomitant administration of colchicine and macrolide antibiotics	Oct, 2028 (4 years from now)
US8093296	TAKEDA PHARMS USA	Methods for concomitant administration of colchicine and macrolide antibiotics	Oct, 2028 (4 years from now)
US8415395	TAKEDA PHARMS USA	Colchicine compositions and methods	Oct, 2028 (4 years from now)
US7619004	TAKEDA PHARMS USA	Methods for concomitant administration of colchicine and macrolide antibiotics	Dec, 2028 (4 years from now)
US7935731	TAKEDA PHARMS USA	Methods for concomitant administration of colchicine and macrolide antibiotics	Dec, 2028 (4 years from now)
US7601758	TAKEDA PHARMS USA	Methods for concomitant administration of colchicine and macrolide antibiotics in the treatment of gout flares	Feb, 2029 (4 years from now)
US8440721	TAKEDA PHARMS USA	Methods for concomitant administration of colchicine and a second active agent	Feb, 2029 (4 years from now)
US7820681	TAKEDA PHARMS USA	Methods for concomitant administration of colchicine and a second active agent	Feb, 2029 (4 years from now)
US8440722	TAKEDA PHARMS USA	Methods for concomitant administration of colchicine and a second active agent	Feb, 2029 (4 years from now)
US7915269	TAKEDA PHARMS USA	Methods for concomitant administration of colchicine and a second active agent	Feb, 2029 (4 years from now)
US7906519	TAKEDA PHARMS USA	Methods for concomitant administration of colchicine and a second active agent	Feb, 2029 (4 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE)	Jul 29, 2016
New Indication(I-603)	Jul 30, 2012

Market Authorisation Date: 29 July, 2009

Treatment: Method of treating gout flares; For the treatment and prophylaxis of gout flares & the treatment of familial mediterranean fever; A method for treatment of gout flares during prophylaxis; Method of ad...

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.3 mg	19 Jul, 2019	1	14 Nov, 2019	17 Feb, 2029	Eligible
0.6 mg	23 Dec, 2011	1		17 Feb, 2029	Extinguished

Strength	Dosage	Availability
0.6MG	TABLET;ORAL	Prescription

COLCRYS family patents

2. Gloperba 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).
US10383820	SCILEX PHARMS	Colchicine drug-to-drug interactions	Nov, 2036 (12 years from now)
US10383821	SCILEX PHARMS	Colchicine drug-to-drug interactions	Nov, 2036 (12 years from now)
US9907751	SCILEX PHARMS	Composition and method of use of colchicine oral liquid	Nov, 2036 (12 years from now)
US10226423	SCILEX PHARMS	Colchicine drug-to-drug interactions	Dec, 2037 (13 years from now)

Market Authorisation Date: 30 January, 2019

Treatment: A method of prophylactic treatment of gout flares in adults comprises administering to a patient a liquid colchicine oral solution

Dosage: SOLUTION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.6 mg/5 mL	02 Apr, 2020	1		20 Dec, 2037	Non-Forfeiture

Strength	Dosage	Availability
0.6MG/5ML	SOLUTION;ORAL	Prescription

GLOPERBA family patents

3. Lodoco 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).
US10130585	AGEPHA PHARMA FZ	Methods of treating and/or preventing cardiovascular disease	Dec, 2034 (10 years from now)
US11026900	AGEPHA PHARMA FZ	Treatment or prevention of cardiovascular events via the administration of a colchicine derivative	Jan, 2035 (10 years from now)
US11026899	AGEPHA PHARMA FZ	Treatment or prevention of cardiovascular events via the administration of a colchicine derivative	Jan, 2035 (10 years from now)
US10842762	AGEPHA PHARMA FZ	Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent	Jan, 2035 (10 years from now)
US10265281	AGEPHA PHARMA FZ	Treatment or prevention of cardiovascular events via the administration of a colchicine derivative	Jan, 2035 (10 years from now)
US10206891	AGEPHA PHARMA FZ	Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent	Jan, 2035 (10 years from now)
US9744144	AGEPHA PHARMA FZ	Method of treating cardiovascular events using colchicine concurrently with an antiplatelet agent	Jan, 2035 (10 years from now)
US11026901	AGEPHA PHARMA FZ	Treatment or prevention of cardiovascular events via the administration of a colchicine derivative	Jan, 2035 (10 years from now)

Market Authorisation Date: 16 June, 2023

Treatment: A method of treating cardiovascular disease; A method for treating and/or reducing the risk of a cardiovascular event; A method of treating and/or reducing the risk of inflammation, atherosclerotic va...

Dosage: TABLET;ORAL

Strength	Dosage	Availability
0.5MG	TABLET;ORAL	Prescription

LODOCO family patents

4. Mitigare 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).
US9399036	HIKMA INTL PHARMS	Methods of colchicine administration	Aug, 2033 (9 years from now)
US9789108	HIKMA INTL PHARMS	Methods of colchicine administration	Aug, 2033 (9 years from now)
US9675613	HIKMA INTL PHARMS	Methods of colchicine administration	Aug, 2033 (9 years from now)
US9555029	HIKMA INTL PHARMS	Methods of colchicine administration	Aug, 2033 (9 years from now)
US8927607	HIKMA INTL PHARMS	Methods of colchicine administration	Aug, 2033 (9 years from now)

Market Authorisation Date: 26 September, 2014

Treatment: Method of using colchicine for the prophylaxis of gout flares

Dosage: CAPSULE;ORAL