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 Apil, Teva Pharms Usa, Valeant Pharms Intl, Alembic Pharms, Alkem Labs Ltd, Mylan, Sun Pharm, Zydus Pharms, Takeda Pharms Usa, G And W Labs Inc, Padagis Israel, Mylan Speciality Lp, Allergan, Actavis Mid Atlantic, Amneal, Amring Pharms, Annora Pharma, Pharm Sourcing, Sandoz Inc, Meda Pharms, and Actavis Labs Fl, and is included in thirty-one 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-four suppliers are listed for this compound.

Summary for mesalamine

International Patents:	36
US Patents:	4
Tradenames:	10
Applicants:	21
NDAs:	31
Drug Master File Entries:	28
Finished Product Suppliers / Packagers:	34
Raw Ingredient (Bulk) Api Vendors:	175
Clinical Trials:	92
Patent Applications:	6,680
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
Eman Ibrahim Elberri, Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University	Phase 2/Phase 3
Hend El-Said Abo Mansour, Biochemistry Department, Faculty of Pharmacy, Menoufia University	Phase 2/Phase 3

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
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	MESALAMINE	mesalamine	TABLET, DELAYED RELEASE;ORAL	211858-001	Jan 25, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Mid Atlantic	MESALAMINE	mesalamine	SUPPOSITORY;RECTAL	205654-001	Aug 14, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Meda Pharms	ROWASA	mesalamine	SUPPOSITORY;RECTAL	019919-001	Dec 18, 1990		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-002	Jul 8, 2004	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	MESALAMINE	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	208954-001	Aug 12, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharm Sourcing	MESALAMINE	mesalamine	SUPPOSITORY;RECTAL	207448-001	Apr 19, 2019	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
Apil	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
Apil	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	PENTASA	mesalamine	CAPSULE, EXTENDED RELEASE;ORAL	020049-001	May 10, 1993	⤷ Sign Up	⤷ Sign Up
Mylan Speciality Lp	ROWASA	mesalamine	ENEMA;RECTAL	019618-001	Dec 24, 1987	⤷ Sign Up	⤷ Sign Up
Takeda Pharms Usa	LIALDA	mesalamine	TABLET, DELAYED RELEASE;ORAL	022000-001	Jan 16, 2007	⤷ Sign Up	⤷ Sign Up
Apil	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 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
Canada	2690450	SUPPOSITOIRE A BASE DE MESALAMINE (MESALAMINE SUPPOSITORY)	⤷ Sign Up
Japan	2013514979		⤷ Sign Up
Japan	2013514979		⤷ Sign Up
Australia	2010339837	Mesalamine suppository	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2008094618		⤷ Sign Up
European Patent Office	2334178	COMPOSITIONS ET PROCÉDÉS PERMETTANT DE TRAITER LES MALADIES INTESTINALES À L AIDE DE MÉSALAMINE GRANULÉE (COMPOSITIONS AND METHODS FOR THE TREATMENT OF BOWEL DISEASES WITH GRANULATED MESALAMINE)	⤷ Sign Up
Spain	2567068		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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