Mesalamine Patent Expiration
Mesalamine was first introduced by Mylan Specialty Lp
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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 12 Jan, 2010 | US7645801 |
| Recordation of Patent Grant Mailed Critical | 12 Jan, 2010 | US7645801 |
| Issue Notification Mailed Critical | 23 Dec, 2009 | US7645801 |
| Application Is Considered Ready for Issue Critical | 11 Dec, 2009 | US7645801 |
| Dispatch to FDC | 11 Dec, 2009 | US7645801 |
| Issue Fee Payment Verified Critical | 10 Dec, 2009 | US7645801 |
| Issue Fee Payment Received Critical | 10 Dec, 2009 | US7645801 |
| Response to Reasons for Allowance | 07 Dec, 2009 | US7645801 |
Mesalamine's 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.
1. ACTAVIS LABS FL
Actavis Laboratories Fl Inc An Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.2GM | tablet, delayed release | Prescription | ORAL | AB | Mar 23, 2018 |
2. ACTAVIS MID ATLANTIC
Actavis Mid Atlantic Llc has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Actavis Mid Atlantic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1GM | suppository | Prescription | RECTAL | AB | Aug 14, 2020 |
3. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Alembic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 375MG | capsule, extended release | Prescription | ORAL | AB | Oct 28, 2022 |
Manufacturing Plant Locations New
Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.
| Country | City | Firm Name | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| India |
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4. ALKEM LABS LTD
Alkem Laboratories Ltd has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 375MG | capsule, extended release | Prescription | ORAL | AB | Jul 15, 2021 |
5. AMNEAL
Amneal Pharmaceuticals Llc has filed for 2 different strengths of generic version for Mesalamine. Given below are the details of the strengths of this generic introduced by Amneal.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1GM | suppository | Discontinued | RECTAL | N/A | Jan 2, 2020 |
| 800MG | tablet, delayed release | Prescription | ORAL | AB | Feb 18, 2025 |
Manufacturing Plant Locations New
Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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6. AMRING PHARMS
Amring Pharmaceuticals Inc has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Amring Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1GM | suppository | Prescription | RECTAL | AB | Jun 21, 2019 |
7. AMTA
Amta Labs Ltd has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Amta.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 375MG | capsule, extended release | Prescription | ORAL | AB | Jun 6, 2023 |
Manufacturing Plant Locations New
Amta's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Amta as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
8. ANNORA PHARMA
Annora Pharma Private Ltd has filed for 2 different strengths of generic version for Mesalamine. Given below are the details of the strengths of this generic introduced by Annora Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1GM | suppository | Prescription | RECTAL | AB | Mar 19, 2020 |
| 1.2GM | tablet, delayed release | Prescription | ORAL | AB | Feb 5, 2024 |
Manufacturing Plant Locations New
Annora Pharma's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Annora Pharma as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
9. AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 375MG | capsule, extended release | Prescription | ORAL | AB | Mar 31, 2023 |
Manufacturing Plant Locations New
Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| India |
| |||
10. ENCUBE
Encube Ethicals Private Ltd has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Encube.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 4GM/60ML | enema | Prescription | RECTAL | AB | May 30, 2023 |
Manufacturing Plant Locations New
Encube's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Encube as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| India |
| |||||
11. G AND W LABS INC
G And W Laboratories Inc has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by G And W Labs Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 4GM/60ML | enema | Discontinued | RECTAL | N/A | Sep 30, 2004 |
12. MYLAN
Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Mesalamine. Given below are the details of the strengths of this generic introduced by Mylan.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.2GM | tablet, delayed release | Discontinued | ORAL | N/A | Nov 20, 2018 |
| 375MG | capsule, extended release | Prescription | ORAL | AB | Nov 20, 2019 |
Manufacturing Plant Locations New
Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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| Canada |
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| Ireland |
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13. NORVIUM BIOSCIENCE
Norvium Bioscience Llc has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1GM | suppository | Prescription | RECTAL | AB | Nov 24, 2015 |
14. NOVAST LABS
Novast Laboratories Inc has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Novast Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 375MG | capsule, extended release | Prescription | ORAL | AB | Aug 22, 2024 |
15. NOVITIUM PHARMA
Novitium Pharma Llc has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Novitium Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 4GM/60ML | enema | Prescription | RECTAL | AB | Apr 16, 2025 |
Manufacturing Plant Locations New
Novitium Pharma's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Novitium Pharma as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
16. PADAGIS ISRAEL
Padagis Israel Pharmaceuticals Ltd has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Padagis Israel.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 4GM/60ML | enema | Prescription | RECTAL | AB | Sep 17, 2004 |
Manufacturing Plant Locations New
Padagis Israel's manufacturing plants are situated in 1 country - Israel. Given below are the details of these plant locations as well as the firm names of Padagis Israel as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| Israel |
| |||
17. RISING
Rising Pharma Holdings Inc has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Rising.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1GM | suppository | Prescription | RECTAL | AB | Apr 14, 2025 |
Manufacturing Plant Locations New
Rising's manufacturing plants are situated in 3 countries - United States, Mexico, India. Given below are the details of these plant locations as well as the firm names of Rising as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Mexico |
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| India |
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18. SANDOZ
Sandoz Inc has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Sandoz.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1GM | suppository | Prescription | RECTAL | AB | Jun 12, 2019 |
Manufacturing Plant Locations New
Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| Austria |
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| United States |
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| Spain |
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| India |
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19. SINOTHERAPEUTICS INC
Sinotherapeutics Inc has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Sinotherapeutics Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.2GM | tablet, delayed release | Prescription | ORAL | AB | May 12, 2023 |
Manufacturing Plant Locations New
Sinotherapeutics Inc's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Sinotherapeutics Inc as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| China |
| |||
20. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Mesalamine. Given below are the details of the strengths of this generic introduced by Sun Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.2GM | tablet, delayed release | Prescription | ORAL | AB | Jan 25, 2019 |
| 500MG | capsule, extended release | Prescription | ORAL | AB | May 11, 2022 |
Manufacturing Plant Locations New
Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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21. TEVA PHARMS INC
Teva Pharmaceuticals Inc has filed for 1 generic for Mesalamine. Given below are the details of the strengths of this generic introduced by Teva Pharms Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 800MG | tablet, delayed release | Prescription | ORAL | AB | Aug 22, 2024 |
22. TEVA PHARMS USA
Teva Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Mesalamine. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 400MG
(reference standard) | capsule, delayed release | Prescription | ORAL | N/A | May 9, 2019 |
| 375MG | capsule, extended release | Discontinued | ORAL | N/A | May 6, 2022 |
23. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Mesalamine. Given below are the details of the strengths of this generic introduced by Zydus Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 1.2GM | tablet, delayed release | Prescription | ORAL | AB | Jun 5, 2017 |
| 800MG
(reference standard) | tablet, delayed release | Prescription | ORAL | AB | Jul 21, 2017 |
| 1GM | suppository | Prescription | RECTAL | AB | Feb 12, 2020 |
| 375MG | capsule, extended release | Prescription | ORAL | AB | Aug 12, 2021 |