Pharsight

1. List of Fenoglide drug patents

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).
US9173847	SALIX	Tablet comprising a fibrate	Oct, 2024 (1 year, 6 months from now)
US8481078	SALIX	Solid dosage form comprising a fibrate	Oct, 2024 (1 year, 6 months from now)
US8124125	SALIX	Solid dosage form comprising a fibrate	Oct, 2024 (1 year, 6 months from now)
US7658944	SALIX	Solid dosage form comprising a fibrate	Dec, 2024 (1 year, 8 months from now)

Drugs and Companies using FENOFIBRATE ingredient

Market Authorisation Date: 10 August, 2007

Treatment: Use of fenofibrate for reducing elevated total cholesterol (total-c), ldl-c, apo-lipoprotein b, or total triglycerides; For reducing total cholesterol (total-c), ldl-c, apo-lipoprotein b, or total tri...

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
40 mg and 120 mg	17 Mar, 2010	1		09 Dec, 2024	Extinguished

Strength	Dosage	Availability
40MG	TABLET;ORAL	Prescription
120MG	TABLET;ORAL	Prescription

FENOGLIDE family patents

United States

Denmark

European Union

Canada

Korea, Republic of

Japan

Australia

China

Hong Kong

Russia

Brazil

Mexico

2. List of Plenvu drug patents

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).
US11529368	SALIX	Colonoscopy—preparation	Mar, 2032 (8 years from now)
US10792306	SALIX	Colonoscopy—preparation	Mar, 2032 (8 years from now)
US10780112	SALIX	Colonoscopy-preparation	Mar, 2032 (8 years from now)
US10646512	SALIX	Colonoscopy - preparation	Mar, 2032 (9 years from now)
US9592252	SALIX	Colonoscopy—preparation	Aug, 2032 (9 years from now)
US8999313	SALIX	Compositions	Sep, 2033 (10 years from now)
US10918723	SALIX	Colon cleansing compositions and methods of use	Sep, 2033 (10 years from now)
US10016504	SALIX	Compositions	Sep, 2033 (10 years from now)
US9707297	SALIX	Compositions	Sep, 2033 (10 years from now)
US9326969	SALIX	Compositions	Sep, 2033 (10 years from now)

Drugs and Companies using ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE ingredient

Market Authorisation Date: 04 May, 2018

Treatment: For cleansing of the colon in preparation for colonoscopy in adults

Dosage: FOR SOLUTION;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
140 g, 5.2 g, 2.2.g, 48.11 g, 9 g and 7.54 g per pouch	06 Dec, 2018	1		10 Sep, 2033

Strength	Dosage	Availability
7.54GM;140GM;2.2GM;48.11GM;5.2GM;9GM	FOR SOLUTION;ORAL	Prescription

PLENVU family patents

United States

European Union

Korea, Republic of

Israel

South Africa

Australia

Singapore

Spain

China

Japan

Denmark

Portugal

United Kingdom

Poland

Canada

Mexico

Slovenia

Lithuania

Hungary

Croatia

Brazil

Malaysia

Taiwan, Province of China

Ukraine

New Zealand

Hong Kong

Argentina

Ireland

Finland

Cyprus

Netherlands

San Marino

India

3. List of Relistor drug patents

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).
US8420663	SALIX	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (6 years from now)
US9492445	SALIX	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (6 years from now)
US9180125	SALIX	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (6 years from now)
US9724343	SALIX	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (6 years from now)
US8956651	SALIX	Oral formulations and lipophilic salts of methylnal trexone	Mar, 2031 (7 years from now)
US10376505	SALIX	Oral formulations and lipophilic salts of methylnaltrexone	Mar, 2031 (7 years from now)
US9314461	SALIX	Oral formulations and lipophilic salts of methylnaltrexone	Mar, 2031 (7 years from now)
US10307417	SALIX	Oral formulations and lipophilic salts of methylnaltrexone	Mar, 2031 (7 years from now)
US8524276	SALIX	Oral formulations and lipophilic salts of methylnaltrexone	Mar, 2031 (7 years from now)

Drugs and Companies using METHYLNALTREXONE BROMIDE ingredient

Market Authorisation Date: 19 July, 2016

Treatment: Treatment of opioid-induced constipation

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	Last patent expiry
12 mg/0.6 mL	22 Jul, 2015	1	31 Dec, 2030
8 mg/0.4 mL	08 Sep, 2015	1	31 Dec, 2030
150 mg	06 Sep, 2016	1	10 Mar, 2031

Strength	Dosage	Availability
150MG	TABLET;ORAL	Prescription

RELISTOR family patents

United States

Japan

New Zealand

European Union

China

Singapore

Korea, Republic of

Israel

Mexico

Brazil

Poland

Australia

Hong Kong

Russia

Argentina

Spain

Taiwan, Province of China

Ukraine

Canada

South Africa

Morocco

Hungary

Costa Rica

Colombia

Portugal

Guatemala

Malaysia

Peru

Chile

Ecuador

Georgia

Tunisia

4. List of Trulance drug patents

Application	Filing Date	Opposition Party	Legal Status
EP02721604A	2010-04-22	Hill, Christopher Michael	Patent maintained as amended
EP02721604A	2010-04-22	CombiMab, Inc.	Patent maintained as amended

Patent	Proceeding Filing Date	Status	Respondent	Petitioner
US7041786	October, 2022	Instituted	Salix Pharmaceuticals, Inc.	MSN Laboratories Private Ltd.
US9610321	June, 2022	Institution Denied	Bausch Health Ireland Limited et al.	Mylan Pharmaceuticals Inc. et al.
US9616097	June, 2022	Institution Denied	Bausch Health Ireland Limited et al.	Mylan Pharmaceuticals Inc. et al.
US9919024	June, 2022	Terminated-Denied	Bausch Health Ireland Limited	Mylan Pharmaceuticals Inc.
US9925231	June, 2022	Institution Denied	Bausch Health Ireland Limited et al.	Mylan Pharmaceuticals Inc. et al.
US7041786	March, 2022	Trial Instituted	Bausch Health Ireland Limited et al.	Mylan Pharmaceuticals Inc. et al.

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7799897	SALIX	Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis	Jun, 2022 (9 months ago)
US7041786	SALIX	Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis	Jan, 2028 (4 years from now)
US10011637	SALIX	Ultra-pure agonists of guanylate cyclase C, method of making and using same	Jun, 2034 (11 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8637451	SALIX	Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis	Mar, 2022 (11 months ago)
US9925231	SALIX	Formulations of guanylate cyclase C agonists and methods of use	Sep, 2031 (8 years from now)
US9919024	SALIX	Formulations of guanylate cyclase C agonists and methods of use	Sep, 2031 (8 years from now)
US9610321	SALIX	Formulations of guanylate cyclase C agonists and methods of use	Sep, 2031 (8 years from now)
US11319346	SALIX	Ultra-pure agonists of guanylate cyclase C, method of making and using same	Mar, 2032 (8 years from now)
US9616097	SALIX	Formulations of guanylate cyclase C agonists and methods of use	Aug, 2032 (9 years from now)
US11142549	SALIX	Ultra-pure agonists of guanylate cyclase C, method of making and using same	Jun, 2034 (11 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jan 19, 2022

Drugs and Companies using PLECANATIDE ingredient

NCE-1 date: 2021-01-19

Market Authorisation Date: 19 January, 2017

Treatment: Elevation of intracellular cgmp resulting in increased intestinal fluid and accelerated transit; Irritable bowel syndrome with constipation; Chronic idiopathic constipation

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
3 mg	19 Jan, 2021	2		05 Jun, 2034

Strength	Dosage	Availability
3MG	TABLET;ORAL	Prescription

TRULANCE family patents

United States

Japan

Australia

European Union

China

Canada

Hong Kong

Spain

Israel

Germany

Brazil

Portugal

Denmark

Cyprus

Korea, Republic of

5. List of Uceris drug patents

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).
US10660858	SALIX	Controlled release and taste masking oral pharmaceutical composition	Sep, 2031 (8 years from now)
US8895064	SALIX	Controlled release and taste masking oral pharmaceutical composition	Sep, 2031 (8 years from now)
US9192581	SALIX	Controlled release and taste masking oral pharmaceutical composition	Sep, 2031 (8 years from now)
US10307375	SALIX	Controlled release and taste masking oral pharmaceutical composition	Sep, 2031 (8 years from now)
US9132093	SALIX	Controlled release and taste making oral pharmaceutical composition	Sep, 2031 (8 years from now)