FDA Orange Book · active-ingredient family
Mesalamine
Mesalamine: 9 brands, 35 generics; first approved Dec 24, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 35 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
9
Generics (ANDA)
35
Listed patents
4
Next patent expiry
Jul 24, 2027
in 10 mo
Brand (NDA) products
Originator applications
- DELZICOLRLDABBVIENDA 2044122013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG CAPSULE, DELAYED RELEASE ORAL Discontinued — - SALIXNDA 0223012008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 375MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - ASACOL HDRLDABBVIENDA 0218302008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 800MG TABLET, DELAYED RELEASE ORAL Discontinued — - TAKEDA PHARMS USANDA 0220002007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.2GM TABLET, DELAYED RELEASE ORAL Rx AB - ABBVIENDA 02125220042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG SUPPOSITORY RECTAL Discontinued — 1GM SUPPOSITORY RECTAL Rx AB - PENTASARLDTAKEDA PHARMS USANDA 02004919932 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 500MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - ROWASARLDMEDA PHARMSNDA 0199191990
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG SUPPOSITORY RECTAL Discontinued — - MYLAN SPECIALITY LPNDA 01961819872 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4GM/60ML ENEMA RECTAL Rx AB 4GM/60ML ENEMA RECTAL Discontinued — - APILNDA 0196511992
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG TABLET, DELAYED RELEASE ORAL Discontinued —
Generic (ANDA) products (35)
Abbreviated applications
- MESALAMINEKLM LABS PVTANDA 2200162026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4GM/60ML ENEMA RECTAL Rx AB - MESALAMINESANDOZANDA 21999720262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 250MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 500MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MESALAMINEANNORA PHARMAANDA 2198642025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 375MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MESALAMINENOVITIUM PHARMAANDA 2152692025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4GM/60ML ENEMA RECTAL Rx AB - MESALAMINERISINGANDA 2190282025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM SUPPOSITORY RECTAL Rx AB - MESALAMINEAMNEALANDA 2150672025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 800MG TABLET, DELAYED RELEASE ORAL Rx AB - MESALAMINENOVAST LABSANDA 2184102024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 375MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MESALAMINETEVA PHARMS INCANDA 2131912024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 800MG TABLET, DELAYED RELEASE ORAL Rx AB - MESALAMINEANNORA PHARMAANDA 2163342024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.2GM TABLET, DELAYED RELEASE ORAL Rx AB - MESALAMINEAMTAANDA 2175332023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 375MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MESALAMINEENCUBEANDA 2169412023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4GM/60ML ENEMA RECTAL Rx AB - MESALAMINESINOTHERAPEUTICS INCANDA 2173372023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.2GM TABLET, DELAYED RELEASE ORAL Rx AB - MESALAMINEAUROBINDO PHARMA LTDANDA 2144772023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 375MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MESALAMINEALEMBICANDA 2169672022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 375MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MESALAMINESUN PHARMANDA 2145852022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MESALAMINETEVA PHARMS USAANDA 2099702022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 375MG CAPSULE, EXTENDED RELEASE ORAL Discontinued — - MESALAMINEZYDUS PHARMSANDA 2089542021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 375MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MESALAMINEALKEM LABS LTDANDA 2142422021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 375MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MESALAMINEACTAVIS MID ATLANTICANDA 2056542020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM SUPPOSITORY RECTAL Rx AB - MESALAMINEANNORA PHARMAANDA 2133772020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM SUPPOSITORY RECTAL Rx AB - MESALAMINEZYDUS PHARMSANDA 2089532020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM SUPPOSITORY RECTAL Rx AB - MESALAMINEAMNEALANDA 2105092020
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM SUPPOSITORY RECTAL Discontinued — - MESALAMINEMYLANANDA 2072712019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 375MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - MESALAMINEJ MOLNERANDA 2083622019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM SUPPOSITORY RECTAL Rx AB - MESALAMINESANDOZANDA 2020652019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM SUPPOSITORY RECTAL Rx AB - MESALAMINERSTEVA PHARMS USAANDA 2078732019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 400MG CAPSULE, DELAYED RELEASE ORAL Rx — - MESALAMINERISINGANDA 2074482019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM SUPPOSITORY RECTAL Rx AB - MESALAMINESUN PHARMANDA 2118582019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.2GM TABLET, DELAYED RELEASE ORAL Rx AB - MESALAMINEMYLANANDA 2035742018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.2GM TABLET, DELAYED RELEASE ORAL Discontinued — - MESALAMINEACTAVIS LABS FLANDA 2038172018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.2GM TABLET, DELAYED RELEASE ORAL Rx AB - MESALAMINERSZYDUS PHARMSANDA 2032862017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 800MG TABLET, DELAYED RELEASE ORAL Rx AB - MESALAMINEZYDUS PHARMSANDA 0916402017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.2GM TABLET, DELAYED RELEASE ORAL Rx AB - MESALAMINEQUAGENANDA 2043542015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1GM SUPPOSITORY RECTAL Rx AB - MESALAMINEG AND W LABS INCANDA 0768412004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4GM/60ML ENEMA RECTAL Discontinued — - MESALAMINEPADAGIS ISRAELANDA 0767512004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 4GM/60ML ENEMA RECTAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7645801 | in 10 mo | SubstanceProduct | |
| 8217083 | in 1 yr 8 mo | Product | |
| 8436051 | in 1 yr 8 mo | Product | |
| 8865688 | in 3 yr 7 mo | U-1310 |
Approval history
FDA approval span
First approval
39 yr 4 mo ago
Most recent approval
6 mo ago
Approvals span 1987–2026 across 44 FDA applications.
Brand (NDA) 920%
Generic (ANDA) 3580%
Mesalamine: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
