FDA Orange Book · active-ingredient family
Indigotindisulfonate sodium
Indigotindisulfonate sodium: 1 brand, 0 generics; first approved Jul 08, 2022; on patent until Nov 25, 2036.
On patent1 exclusivity period
Generic status & protection
Protected until Nov 25, 2036 (earliest listed patent expiry).
Earliest patent expiry Nov 25, 2036Latest exclusivity ends Jul 08, 2027
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
3
Next patent expiry
Nov 25, 2036
in 10 yr 6 mo
Originator applications
Brand (NDA) products
PROVEPHARM SASNDA 2162642022
PROVEPHARM SASNDA 2162642022
| Strength | Dosage form | Route | Status | TE |
|---|---|---|---|---|
| 40MG/5ML (8MG/ML) | SOLUTION | INTRAVENOUS | Rx | — |
Protection horizon
Patent & exclusivity timeline
Patent expiryExclusivity endToday
Hatch-Waxman
Marketing exclusivity
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Jul 08, 2027
in 1 yr
Orange Book patent file
Listed patents
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11845867 | Nov 25, 2036 | in 10 yr 6 mo | Substance |
| 10927258 | Dec 23, 2037 | in 11 yr 7 mo | Substance |
| 11499050 | Dec 23, 2037 | in 11 yr 7 mo | Substance |
FDA approval span
Approval history
First approval
Jul 08, 2022
4 yr 1 mo ago
Most recent approval
Jul 08, 2022
4 yr 1 mo ago
All 1 application were approved in 2022.
Brand (NDA) 1100%
Generic (ANDA) 00%
Indigotindisulfonate sodium — 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 BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
