FDA Orange Book · active-ingredient family
Balsalazide disodium
Balsalazide disodium: 2 brands, 6 generics; first approved Jul 18, 2000; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 6 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
2
Generics (ANDA)
6
Listed patents
6
Next patent expiry
Aug 02, 2026
22 d ago
Brand (NDA) products
Originator applications
Generic (ANDA) products (6)
Abbreviated applications
- BALSALAZIDE DISODIUMCARNEGIEANDA 2194222025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG CAPSULE ORAL Rx AB - BALSALAZIDE DISODIUMZYDUS LIFESCIENCESANDA 2175922023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG CAPSULE ORAL Rx AB - BALSALAZIDE DISODIUMAARXION ANDA HLDINGANDA 2063362015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.1GM TABLET ORAL Discontinued — - BALSALAZIDE DISODIUMAPOTEXANDA 0778832007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG CAPSULE ORAL Rx AB - BALSALAZIDE DISODIUMHIKMAANDA 0778062007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG CAPSULE ORAL Rx AB - BALSALAZIDE DISODIUMNOVITIUM PHARMAANDA 0778072007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 750MG CAPSULE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9192616 | 22 d ago | U-1229 | |
| 7625884 | today | U-141 | |
| 7452872 | today | U-141 | |
| 7452872*PED | in 6 mo | ||
| 7625884*PED | in 6 mo | ||
| 8497256 | in 4 yr 11 mo | U-1229 |
Approval history
FDA approval span
First approval
26 yr 6 mo ago
Most recent approval
1 yr 5 mo ago
Approvals span 2000–2025 across 8 FDA applications.
Brand (NDA) 225%
Generic (ANDA) 675%
Balsalazide disodium: 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.
