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Last Updated: April 19, 2024

Mesalamine - Generic Drug Details

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What are the generic drug sources for mesalamine and what is the scope of patent protection?

Mesalamine is the generic ingredient in ten branded drugs marketed by Abbvie, Teva Pharms Usa, Salix, Alembic, Alkem Labs Ltd, Amta, Aurobindo Pharma Ltd, Mylan, Sun Pharm, Zydus Pharms, Takeda Pharms Usa, Encube, G And W Labs Inc, Padagis Israel, Mylan Speciality Lp, Actavis Mid Atlantic, Amneal, Amring Pharms, Annora Pharma, Pharm Sourcing, Sandoz, Meda Pharms, Apil, Actavis Labs Fl, and Sinotherapeutics Inc, and is included in thirty-six NDAs. There are four patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Mesalamine has thirty-six patent family members in eighteen countries.

There are twenty-eight drug master file entries for mesalamine. Thirty-six suppliers are listed for this compound.

Summary for mesalamine

International Patents:	36
US Patents:	4
Tradenames:	10
Applicants:	25
NDAs:	36
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	181
Clinical Trials:	93
Patent Applications:	6,876
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for mesalamine
Drug Sales Revenues:	Drug sales revenues for mesalamine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for mesalamine
What excipients (inactive ingredients) are in mesalamine?	mesalamine excipients list
DailyMed Link:	mesalamine at DailyMed

See drug prices for mesalamine

Drug Sales Revenue Trends for mesalamine

See drug sales revenues for mesalamine

Recent Clinical Trials for mesalamine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
AHS Cancer Control Alberta	Phase 2
Fedaa Abd El-monem Kamal El-deen Kotkata Faculty of Pharmacy, Tanta University	Phase 2
Eman Ibrahim Elberri, Faculty of Pharmacy, Tanta University	Phase 2

See all mesalamine clinical trials

Pharmacology for mesalamine

Drug Class	Aminosalicylate

Medical Subject Heading (MeSH) Categories for mesalamine

Anti-Inflammatory Agents, Non-Steroidal

Paragraph IV (Patent) Challenges for MESALAMINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DELZICOL	Delayed-release Capsules	mesalamine	400 mg	204412	1	2014-06-17
CANASA	Suppository	mesalamine	1000 mg	021252	1	2013-05-24
APRISO	Extended-release Capsules	mesalamine	0.375 g	022301	1	2012-04-03
ASACOL HD	Delayed-release Tablets	mesalamine	800 mg	021830	1	2011-07-13
LIALDA	Delayed-release Tablets	mesalamine	1.2 g	022000	1	2009-12-16
ASACOL	Delayed-release Tablets	mesalamine	400 mg	019651	1	2007-06-22

US Patents and Regulatory Information for mesalamine

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zydus Pharms	MESALAMINE	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	208954-001	Aug 12, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm	MESALAMINE	mesalamine	TABLET, DELAYED RELEASE;ORAL	211858-001	Jan 25, 2019	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Meda Pharms	ROWASA	mesalamine	SUPPOSITORY;RECTAL	019919-001	Dec 18, 1990		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal	MESALAMINE	mesalamine	SUPPOSITORY;RECTAL	210509-001	Jan 2, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Apil	ASACOL	mesalamine	TABLET, DELAYED RELEASE;ORAL	019651-001	Jan 31, 1992		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for mesalamine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013	⤷ Try a Trial	⤷ Try a Trial
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008	⤷ Try a Trial	⤷ Try a Trial
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	⤷ Try a Trial	⤷ Try a Trial
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008	⤷ Try a Trial	⤷ Try a Trial
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for mesalamine

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008094618		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2010040113		⤷ Try a Trial
Chile	2012001636	Supositorio rectal de mesalamina , en donde las particulas de mesalamina tienen un area de superficie de 0,1 m2/g a 1,3 m2/g, util en el tratamiento de proctitis ulcerosa activa.	⤷ Try a Trial
Singapore	181169	MESALAMINE SUPPOSITORY	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2010040021		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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