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Serving leading biopharmaceutical companies globally:

Cipla
Boehringer Ingelheim
Cerilliant
Medtronic
Federal Trade Commission
Healthtrust
Fuji
McKesson
Express Scripts
Chinese Patent Office

Generated: February 18, 2018

DrugPatentWatch Database Preview

Mesalamine - Generic Drug Details

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

Mesalamine
is the generic ingredient in ten branded drugs marketed by Apil, Valeant Pharms Intl, Shire, G And W Labs Inc, Perrigo Israel, Mylan Speciality Lp, Allergan Sales Llc, Mylan Pharms Inc, Meda Pharms, and Zydus Pharms Usa Inc, and is included in fourteen NDAs. There are fifteen patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Mesalamine has one hundred and three patent family members in twenty-seven countries.

There are twenty-eight drug master file entries for mesalamine. Twenty-one suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for mesalamine
Pharmacology for mesalamine
Ingredient-typeAminosalicylic Acids
Drug ClassAminosalicylate
Medical Subject Heading (MeSH) Categories for mesalamine
Tentative approvals for MESALAMINE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial1000MGSUPPOSITORY;RECTAL

US Patents and Regulatory Information for mesalamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan Sales Llc CANASA mesalamine SUPPOSITORY;RECTAL 021252-001 Jan 5, 2001 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apil DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Shire LIALDA mesalamine TABLET, DELAYED RELEASE;ORAL 022000-001 Jan 16, 2007 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Zydus Pharms Usa Inc MESALAMINE mesalamine TABLET, DELAYED RELEASE;ORAL 203286-001 Jul 21, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Allergan Sales Llc CANASA mesalamine SUPPOSITORY;RECTAL 021252-002 Nov 5, 2004 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
G And W Labs Inc MESALAMINE mesalamine ENEMA;RECTAL 076841-001 Sep 30, 2004 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms Intl APRISO mesalamine CAPSULE, EXTENDED RELEASE;ORAL 022301-001 Oct 31, 2008 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for mesalamine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-001 May 10, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Apil DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Speciality Lp ROWASA mesalamine ENEMA;RECTAL 019618-001 Dec 24, 1987 ➤ Try a Free Trial ➤ Try a Free Trial
Apil DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013 ➤ Try a Free Trial ➤ Try a Free Trial
Shire PENTASA mesalamine CAPSULE, EXTENDED RELEASE;ORAL 020049-001 May 10, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ASACOL mesalamine TABLET, DELAYED RELEASE;ORAL 019651-001 Jan 31, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ASACOL mesalamine TABLET, DELAYED RELEASE;ORAL 019651-001 Jan 31, 1992 ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Speciality Lp ROWASA mesalamine ENEMA;RECTAL 019618-001 Dec 24, 1987 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for mesalamine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,277,412 Pellet-type formulation intended for treating the intestinal tract ➤ Try a Free Trial
8,217,082 Reduced irritant enema for the treatment of inflammatory bowel disease (IBD) ➤ Try a Free Trial
7,547,451 Pellet formulation for the treatment of the intestinal tract ➤ Try a Free Trial
7,541,384 Mesalamine suppository ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for mesalamine

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Army
Chinese Patent Office
Citi
UBS
McKesson
Cantor Fitzgerald
AstraZeneca
Express Scripts
QuintilesIMS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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