Mesalamine - Generic Drug Details

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What are the generic drug sources for mesalamine and what is the scope of freedom to operate?

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, Novast Labs, 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, Rising, Sandoz, Meda Pharms, Apil, Actavis Labs Fl, Sinotherapeutics Inc, and Teva Pharms Inc, and is included in thirty-eight 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. Forty suppliers are listed for this compound.

Summary for mesalamine

International Patents:	36
US Patents:	4
Tradenames:	10
Applicants:	27
NDAs:	38
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	181
Clinical Trials:	94
Patent Applications:	6,627
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
Tanta University	N/A
AHS Cancer Control Alberta	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
Teva Pharms Usa	MESALAMINE	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	209970-001	May 6, 2022		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sinotherapeutics Inc	MESALAMINE	mesalamine	TABLET, DELAYED RELEASE;ORAL	217337-001	May 12, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	MESALAMINE	mesalamine	SUPPOSITORY;RECTAL	202065-001	Jun 12, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	MESALAMINE	mesalamine	SUPPOSITORY;RECTAL	207448-001	Apr 19, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	MESALAMINE	mesalamine	SUPPOSITORY;RECTAL	204354-001	Nov 24, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Israel	MESALAMINE	mesalamine	ENEMA;RECTAL	076751-001	Sep 17, 2004	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	⤷ Sign Up	⤷ Sign Up
Abbvie	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013	⤷ Sign Up	⤷ Sign Up
Abbvie	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	⤷ Sign Up	⤷ Sign Up
Salix	APRISO	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	022301-001	Oct 31, 2008	⤷ Sign Up	⤷ Sign Up
>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		⤷ Sign Up
China	102238868	Compositions and methods for the treatment of bowel diseases with granulated mesalamine	⤷ Sign Up
Eurasian Patent Organization	022886	СПОСОБ ПОДДЕРЖАНИЯ РЕМИССИИ ЯЗВЕННОГО КОЛИТА У ПАЦИЕНТОВ (METHOD OF MAINTAINING REMISSION OF ULCERATIVE COLITIS IN PATIENTS)	⤷ Sign Up
Canada	2784772	SUPPOSITOIRE DE MESALAMINE (MESALAMINE SUPPOSITORY)	⤷ Sign Up
Canada	2690450	SUPPOSITOIRE A BASE DE MESALAMINE (MESALAMINE SUPPOSITORY)	⤷ Sign Up
Australia	2010339837	Mesalamine suppository	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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