Mesalamine - Generic Drug Details
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What are the generic 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 |
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 |
Pharmacology for mesalamine
Drug Class | Aminosalicylate |
Medical Subject Heading (MeSH) Categories for mesalamine
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Encube | MESALAMINE | mesalamine | ENEMA;RECTAL | 216941-001 | May 30, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Takeda Pharms Usa | LIALDA | mesalamine | TABLET, DELAYED RELEASE;ORAL | 022000-001 | Jan 16, 2007 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Abbvie | CANASA | mesalamine | SUPPOSITORY;RECTAL | 021252-002 | Nov 5, 2004 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Pharm Sourcing | MESALAMINE | mesalamine | SUPPOSITORY;RECTAL | 207448-001 | Apr 19, 2019 | AB | RX | 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
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Mylan Speciality Lp | ROWASA | mesalamine | ENEMA;RECTAL | 019618-001 | Dec 24, 1987 | ⤷ Try a Trial | ⤷ Try a Trial |
Abbvie | DELZICOL | mesalamine | CAPSULE, DELAYED RELEASE;ORAL | 204412-001 | Feb 1, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
Takeda Pharms Usa | PENTASA | mesalamine | CAPSULE, EXTENDED RELEASE;ORAL | 020049-001 | May 10, 1993 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for mesalamine
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 2690450 | SUPPOSITOIRE A BASE DE MESALAMINE (MESALAMINE SUPPOSITORY) | ⤷ Try a Trial |
Japan | 2013514979 | ⤷ Try a Trial | |
Japan | 2013514979 | ⤷ Try a Trial | |
Australia | 2010339837 | Mesalamine suppository | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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