FDA Orange Book · active-ingredient family
Indocyanine green
Indocyanine green: 3 brands, 2 generics; first approved Nov 21, 2007; generic available.
Generic available2 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 2 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
3
Generics (ANDA)
2
Listed patents
5
Next patent expiry
Jun 04, 2028
in 1 yr 9 mo
Brand (NDA) products
Originator applications
- PROVEPHARM SASNDA 2185792026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/10ML (2.5MG/ML) SOLUTION INTRAVENOUS, INTERSTITIAL Rx — - NOVADAQ TECHNDA 2115802018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/VIAL POWDER INTRAVENOUS, INTERSTITIAL Rx — - IC-GREENRLDRENEW PHARMSNDA 011525—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/VIAL INJECTABLE INJECTION Rx AP 50MG/VIAL INJECTABLE INJECTION Discontinued — 10MG/VIAL INJECTABLE INJECTION Rx — 40MG/VIAL INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (2)
Abbreviated applications
- INDOCYANINE GREENZYDUS LIFESCIENCESANDA 2191392026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/VIAL INJECTABLE INJECTION Rx AP - INDOCYANINE GREENRSRENEW PHARMSANDA 0408112007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25MG/VIAL INJECTABLE INJECTION Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- CGTFDA marketing exclusivity
in 5 mo
- I-911New indication exclusivity (3 years)
4 mo ago
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8185176 | in 1 yr 9 mo | U-2462 | |
| 8647605 | in 2 yr 5 mo | U-2468 | |
| 8406860 | in 2 yr 7 mo | U-2463 | |
| 10631746 | in 9 yr | ProductU-2815 | |
| 11712320 | in 13 yr | Product |
Approval history
FDA approval span
First approval
19 yr 1 mo ago
Most recent approval
2 mo ago
Approvals span 2007–2026 across 5 FDA applications.
Brand (NDA) 360%
Generic (ANDA) 240%
Indocyanine green: 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.
