Pharsight

1. Apriso patents expiration

Patent	Proceeding Filing Date	Status	Respondent	Petitioner

US8865688	July, 2016	Terminated-Other
US8865688	July, 2016	Terminated-Other
US8865688	December, 2015	FWD Entered	SALIX PHARMACEUTICALS, LTD.	GeneriCo, LLC

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.
US6551620	SALIX	Pellet formulation for the treatment of the intestinal tract	Apr, 2018 (6 years ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8496965	SALIX	Pellet formulation for the treatment of the intenstinal tract	Apr, 2018 (6 years ago)
US8956647	SALIX	Pellet formulation for the treatment of the intestinal tract	Apr, 2018 (6 years ago)
US8911778	SALIX	Pellet formulation for the treatment of the intestinal tract	Apr, 2018 (6 years ago)
US8337886	SALIX	Pellet formulation for the treatment of the intestinal tract	Apr, 2018 (6 years ago)
US8940328	SALIX	Pellet formulation for the treatment of the intestinal tract	Apr, 2018 (6 years ago)
US8865688	SALIX	Compositions and methods for treatment of bowel diseases with granulated mesalamine	May, 2030 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Oct 31, 2011

Drugs and Companies using MESALAMINE ingredient

Market Authorisation Date: 31 October, 2008

Treatment: For the maintenance of remission of ulcerative colitis; For the maintenance of remission of ulcerative colitis in subjects 18 years of age and older

Dosage: CAPSULE, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.375 g	03 Apr, 2012	1		20 Apr, 2018	Extinguished

Strength	Dosage	Availability
375MG	CAPSULE, EXTENDED RELEASE;ORAL	Prescription

APRISO family patents

2. Fenoglide 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).
US8481078	SALIX	Solid dosage form comprising a fibrate	Oct, 2024 (5 months from now)
US8124125	SALIX	Solid dosage form comprising a fibrate	Oct, 2024 (5 months from now)
US9173847	SALIX	Tablet comprising a fibrate	Oct, 2024 (5 months from now)
US7658944	SALIX	Solid dosage form comprising a fibrate	Dec, 2024 (7 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

3. Plenvu 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).
US10792306	SALIX	Colonoscopy—preparation	Mar, 2032 (7 years from now)
US10780112	SALIX	Colonoscopy-preparation	Mar, 2032 (7 years from now)
US11529368	SALIX	Colonoscopy—preparation	Mar, 2032 (7 years from now)
US10646512	SALIX	Colonoscopy - preparation	Mar, 2032 (7 years from now)
US9592252	SALIX	Colonoscopy—preparation	Aug, 2032 (8 years from now)
US9326969	SALIX	Compositions	Sep, 2033 (9 years from now)
US10016504	SALIX	Compositions	Sep, 2033 (9 years from now)
US8999313	SALIX	Compositions	Sep, 2033 (9 years from now)
US10918723	SALIX	Colon cleansing compositions and methods of use	Sep, 2033 (9 years from now)
US9707297	SALIX	Compositions	Sep, 2033 (9 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	May 04, 2021

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

4. Relistor 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).
US6559158	SALIX	Use of methylnaltrexone and related compounds to treat chronic opioid use side affects	Nov, 2017 (6 years ago)
US9724343	SALIX	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US8420663	SALIX	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US9492445	SALIX	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US9180125	SALIX	Peripheral opioid receptor antagonists and uses thereof	Sep, 2029 (5 years from now)
US10307417	SALIX	Oral formulations and lipophilic salts of methylnaltrexone	Mar, 2031 (6 years from now)
US8956651	SALIX	Oral formulations and lipophilic salts of methylnal trexone	Mar, 2031 (6 years from now)
US9314461	SALIX	Oral formulations and lipophilic salts of methylnaltrexone	Mar, 2031 (6 years from now)
US8524276	SALIX	Oral formulations and lipophilic salts of methylnaltrexone	Mar, 2031 (6 years from now)
US10376505	SALIX	Oral formulations and lipophilic salts of methylnaltrexone	Mar, 2031 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Jul 19, 2019

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

5. Trulance patents expiration

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	Final Written Decision	Bausch Health Ireland Limited et al.	MSN Laboratories Private Ltd. et al.
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	Institution Denied	Bausch Health Ireland Limited et al.	Mylan Pharmaceuticals Inc. et al.
US9925231	June, 2022	Institution Denied	Bausch Health Ireland Limited et al.	Mylan Pharmaceuticals Inc. et al.
US7041786	March, 2022	Final Written Decision	Bausch Health Ireland Limited et al.	Mylan Pharmaceuticals Inc. et al.

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.
US7799897	SALIX	Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis	Jun, 2022 (1 year, 10 months ago)
US7041786	SALIX	Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis	Jan, 2028 (3 years from now)
US10011637	SALIX	Ultra-pure agonists of guanylate cyclase C, method of making and using same	Jun, 2034 (10 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).
US8637451	SALIX	Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis	Mar, 2022 (2 years ago)
US9610321	SALIX	Formulations of guanylate cyclase C agonists and methods of use	Sep, 2031 (7 years from now)
US9925231	SALIX	Formulations of guanylate cyclase C agonists and methods of use	Sep, 2031 (7 years from now)
US9919024	SALIX	Formulations of guanylate cyclase C agonists and methods of use	Sep, 2031 (7 years from now)
US11319346	SALIX	Ultra-pure agonists of guanylate cyclase C, method of making and using same	Mar, 2032 (7 years from now)
US9616097	SALIX	Formulations of guanylate cyclase C agonists and methods of use	Aug, 2032 (8 years from now)
US11834521	SALIX	Ultra-pure agonists of guanylate cyclase C, method of making and using same	Jun, 2034 (10 years from now)
US11142549	SALIX	Ultra-pure agonists of guanylate cyclase C, method of making and using same	Jun, 2034 (10 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Chemical Entity Exclusivity(NCE)	Jan 19, 2022
New Indication(I-764)	Jan 24, 2021

Drugs and Companies using PLECANATIDE ingredient

NCE-1 date: 19 January, 2021

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

6. Uceris 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).
US5914122	SALIX	Stable budesonide solutions, method of preparing them and use of these solutions as enema preparations and pharmaceutical foams	Dec, 2015 (8 years ago)
US9320716	SALIX	Controlled release and taste masking oral pharmaceutical compositions	Jun, 2020 (3 years ago)
US7410651	SALIX	Controlled release and taste masking oral pharmaceutical composition	Jun, 2020 (3 years ago)
US7431943	SALIX	Controlled release and taste masking oral pharmaceutical compositions	Jun, 2020 (3 years ago)
US10064878	SALIX	Controlled release and taste masking oral pharmaceutical compositions	Jun, 2020 (3 years ago)
US8293273	SALIX	Controlled release and taste masking oral pharmaceutical composition	Jun, 2020 (3 years ago)
US8784888	SALIX	Controlled release and taste masking oral pharmaceutical composition	Jun, 2020 (3 years ago)
US10105374	SALIX	Controlled release and taste masking oral pharmaceutical compositions	Jun, 2020 (3 years ago)
US10143698	SALIX	Controlled release and taste masking oral pharmaceutical compositions	Jun, 2020 (3 years ago)
US9532954	SALIX	Controlled release and taste masking oral pharmaceutical compositions	Jun, 2020 (3 years ago)
USRE43799	SALIX	Controlled release and taste masking oral pharmaceutical composition	Jun, 2020 (3 years ago)
US9192581	SALIX	Controlled release and taste masking oral pharmaceutical composition	Sep, 2031 (7 years from now)
US10660858	SALIX	Controlled release and taste masking oral pharmaceutical composition	Sep, 2031 (7 years from now)
US9132093	SALIX	Controlled release and taste making oral pharmaceutical composition	Sep, 2031 (7 years from now)
US8895064	SALIX	Controlled release and taste masking oral pharmaceutical composition	Sep, 2031 (7 years from now)
US10307375	SALIX	Controlled release and taste masking oral pharmaceutical composition	Sep, 2031 (7 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Oct 07, 2017

Drugs and Companies using BUDESONIDE ingredient

Market Authorisation Date: 07 October, 2014

Treatment: Induction of remission in patients with active, mild to moderate ulcerative colitis

Dosage: AEROSOL, FOAM;RECTAL; TABLET, EXTENDED RELEASE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
9 mg	11 Mar, 2013	1	03 Jul, 2018	09 Jun, 2020	Deferred

Strength	Dosage	Availability
2MG/ACTUATION	AEROSOL, FOAM;RECTAL	Prescription
9MG	TABLET, EXTENDED RELEASE;ORAL	Prescription

UCERIS family patents

7. Zegerid 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.
US6780882	SALIX	Substituted benzimidazole dosage forms and method of using same	Jul, 2016 (7 years ago)
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
USRE45198	SALIX	Omeprazole solution and method for using same	Jul, 2016 (7 years ago)
US7399772	SALIX	Substituted benzimidazole dosage forms and method of using same	Jul, 2016 (7 years ago)
US5840737	SALIX	Omeprazole solution and method for using same	Jul, 2016 (7 years ago)
US6645988	SALIX	Substituted benzimidazole dosage forms and method of using same	Jul, 2016 (7 years ago)
US6699885	SALIX	Substituted benzimidazole dosage forms and methods of using same	Jul, 2016 (7 years ago)
US6489346	SALIX	Substituted benzimidazole dosage forms and method of using same	Jul, 2016 (7 years ago)

Drugs and Companies using OMEPRAZOLE; SODIUM BICARBONATE ingredient

Market Authorisation Date: 15 June, 2004

Treatment: Short-term treatment of active duodenal ulcer; Treatment of heartburn and other symptoms associated with gerd; Short-term treatment of erosive esophagitis; Maintenance of healing of erosive esophagiti...

Dosage: FOR SUSPENSION;ORAL; CAPSULE;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
20 mg/1100 mg and 40 mg/1100 mg	30 Apr, 2007	1	25 May, 2010	16 Jul, 2016	Eligible
20mg/1680mg per packet	13 Nov, 2007	1	19 Apr, 2013	16 Jul, 2016	Deferred
40 mg/1680 mg per packet	24 Aug, 2007	1	19 Apr, 2013	16 Jul, 2016	Deferred

Pharsight

Salix patents expiration

1. Apriso patents expiration

APRISO family patents

2. Fenoglide patents expiration

FENOGLIDE family patents

3. Plenvu patents expiration

PLENVU family patents

4. Relistor patents expiration

RELISTOR family patents

5. Trulance patents expiration

TRULANCE family patents

6. Uceris patents expiration

UCERIS family patents

7. Zegerid patents expiration

ZEGERID family patents

Related content

Strength	Dosage	Availability
40MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription
40MG;1.1GM	CAPSULE;ORAL	Prescription
20MG;1.1GM	CAPSULE;ORAL	Prescription
20MG/PACKET;1.68GM/PACKET	FOR SUSPENSION;ORAL	Prescription