Mesalamine Patent Expiration

Mesalamine was first introduced by Mylan Specialty Lp in its drug Rowasa on Dec 24, 1987. Other drugs containing Mesalamine are Pentasa, Delzicol, Asacol Hd, Apriso, Canasa, Asacol, Lialda, Sfrowasa. 29 different companies have introduced drugs containing Mesalamine.


Mesalamine Patents

Given below is the list of patents protecting Mesalamine, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Apriso US8865688 Compositions and methods for treatment of bowel diseases with granulated mesalamine May 01, 2030 Salix
Canasa US8217083 Mesalamine suppository Jun 06, 2028 Abbvie
Canasa US8436051 Mesalamine suppository Jun 06, 2028 Abbvie
Sfrowasa US7645801 Reduced irritant enema for treatment of inflammatory bowel disease (IBD) Jul 24, 2027 Mylan Speciality Lp
Asacol Hd US6893662 Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures Nov 15, 2021

(Expired)

Abbvie
Asacol Hd US8580302 Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures Nov 15, 2021

(Expired)

Abbvie
Asacol Hd US9089492 Pharmaceutical dosage form with multiple coatings for reduced impact of coating fractures Nov 15, 2021

(Expired)

Abbvie
Lialda US6773720 Mesalazine controlled release oral pharmaceutical compositions Jun 08, 2020

(Expired)

Takeda Pharms Usa
Delzicol US6649180 Hard capsule formed of cellulose ether film with a specific content of methoxyl and hydroxypropoxyl groups Apr 13, 2020

(Expired)

Abbvie
Apriso US6551620 Pellet formulation for the treatment of the intestinal tract Apr 20, 2018

(Expired)

Salix
Apriso US8337886 Pellet formulation for the treatment of the intestinal tract Apr 20, 2018

(Expired)

Salix
Apriso US8496965 Pellet formulation for the treatment of the intenstinal tract Apr 20, 2018

(Expired)

Salix
Apriso US8911778 Pellet formulation for the treatment of the intestinal tract Apr 20, 2018

(Expired)

Salix
Apriso US8940328 Pellet formulation for the treatment of the intestinal tract Apr 20, 2018

(Expired)

Salix
Apriso US8956647 Pellet formulation for the treatment of the intestinal tract Apr 20, 2018

(Expired)

Salix
Asacol US5541170 Orally administrable pharmaceutical compositions Jul 30, 2013

(Expired)

Apil
Asacol US5541171 Orally administrable pharmaceutical composition Jul 30, 2013

(Expired)

Apil
Asacol Hd US5541170 Orally administrable pharmaceutical compositions Jul 30, 2013

(Expired)

Abbvie
Asacol Hd US5541171 Orally administrable pharmaceutical composition Jul 30, 2013

(Expired)

Abbvie
Delzicol US5541170 Orally administrable pharmaceutical compositions Jul 30, 2013

(Expired)

Abbvie
Delzicol US5541171 Orally administrable pharmaceutical composition Jul 30, 2013

(Expired)

Abbvie



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Mesalamine's patents.

Given below is the list recent legal activities going on the following patents of Mesalamine.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 29 Jun, 2021 US7645801
Entity Status Set To Undiscounted (Initial Default Setting or Status Change) 11 Jul, 2013 US7645801
Patent Issue Date Used in PTA Calculation 12 Jan, 2010 US7645801
Recordation of Patent Grant Mailed 12 Jan, 2010 US7645801
Issue Notification Mailed 23 Dec, 2009 US7645801
Application Is Considered Ready for Issue 11 Dec, 2009 US7645801
Dispatch to FDC 11 Dec, 2009 US7645801
Issue Fee Payment Verified 10 Dec, 2009 US7645801
Issue Fee Payment Received 10 Dec, 2009 US7645801
Response to Reasons for Allowance 07 Dec, 2009 US7645801


Mesalamine's Family Patents

Family Patents

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Mesalamine Generic API Manufacturers

Several generic applications have been filed for Mesalamine. The first generic version for Mesalamine was by Padagis Israel Pharmaceuticals Ltd and was approved on Sep 17, 2004. And the latest generic version is by Novitium Pharma Llc and was approved on Apr 16, 2025.

Given below is the list of companies who have filed for Mesalamine generic, along with the locations of their manufacturing plants worldwide.