FDA Orange Book · active-ingredient family
Irinotecan hydrochloride
Irinotecan hydrochloride: 2 brands, 26 generics; first approved Jun 14, 1996; generic available.
Generic available2 exclusivity periodsHas discontinued products
Generic status & protection
Generic available: 26 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
2
Generics (ANDA)
26
Listed patents
14
Next patent expiry
Jan 06, 2027
in 3 mo
Brand (NDA) products
Originator applications
- IPSENNDA 2077932015
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) INJECTABLE, LIPOSOMAL INTRAVENOUS Rx — - PFIZER INCNDA 02057119963 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Rx AP 100MG/5ML (20MG/ML) INJECTABLE INJECTION Rx AP 300MG/15ML (20MG/ML) INJECTABLE INJECTION Rx AP
Generic (ANDA) products (26)
Abbreviated applications
- IRINOTECAN HYDROCHLORIDEEUGIA PHARMAANDA 21327820204 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Rx AP 100MG/5ML (20MG/ML) INJECTABLE INJECTION Rx AP 300MG/15ML (20MG/ML) INJECTABLE INJECTION Rx AP 500MG/25ML (20MG/ML) INJECTABLE INJECTION Rx AP - IRINOTECAN HYDROCHLORIDEGLANDANDA 21299320192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Rx AP 100MG/5ML (20MG/ML) INJECTABLE INJECTION Rx AP - IRINOTECAN HYDROCHLORIDEADAPTISANDA 20871820183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Rx AP 100MG/5ML (20MG/ML) INJECTABLE INJECTION Rx AP 300MG/15ML (20MG/ML) INJECTABLE INJECTION Rx AP - IRINOTECAN HYDROCHLORIDEINTAS PHARMS USAANDA 20305420172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Rx AP 100MG/5ML (20MG/ML) INJECTABLE INJECTION Rx AP - IRINOTECAN HYDROCHLORIDEINGENUS PHARMS LLCANDA 20693520172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Rx AP 100MG/5ML (20MG/ML) INJECTABLE INJECTION Rx AP - IRINOTECAN HYDROCHLORIDEQILU PHARM HAINANANDA 20338020163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Rx AP 100MG/5ML (20MG/ML) INJECTABLE INJECTION Rx AP 300MG/15ML (20MG/ML) INJECTABLE INJECTION Rx AP - IRINOTECAN HYDROCHLORIDEEMCURE PHARMS LTDANDA 20077120122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Discontinued — 100MG/5ML (20MG/ML) INJECTABLE INJECTION Discontinued — - IRINOTECAN HYDROCHLORIDEHENGRUI PHARMAANDA 09067520112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 100MG/5ML (20MG/ML) INJECTABLE INJECTION Discontinued — 40MG/2ML (20MG/ML) INJECTABLE INJECTION Discontinued — - IRINOTECAN HYDROCHLORIDEPHARMOBEDIENTANDA 09039320112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Rx AP 100MG/5ML (20MG/ML) INJECTABLE INJECTION Rx AP - IRINOTECAN HYDROCHLORIDEHIKMA FARMACEUTICAANDA 09103220102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Rx AP 100MG/5ML (20MG/ML) INJECTABLE INJECTION Rx AP - IRINOTECAN HYDROCHLORIDECHARTWELL RXANDA 07895320102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Discontinued — 100MG/5ML (20MG/ML) INJECTABLE INJECTION Discontinued — - IRINOTECAN HYDROCHLORIDESANDOZANDA 09013720092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Discontinued — 100MG/5ML (20MG/ML) INJECTABLE INJECTION Discontinued — - IRINOTECAN HYDROCHLORIDEEPIC PHARMA LLCANDA 09072620092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Rx AP 100MG/5ML (20MG/ML) INJECTABLE INJECTION Rx AP - IRINOTECAN HYDROCHLORIDEHISUN PHARM HANGZHOUANDA 09001620092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Discontinued — 100MG/5ML (20MG/ML) INJECTABLE INJECTION Discontinued — - IRINOTECAN HYDROCHLORIDEHIKMAANDA 07875320082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Rx AP 100MG/5ML (20MG/ML) INJECTABLE INJECTION Rx AP - IRINOTECAN HYDROCHLORIDEACCORD HLTHCAREANDA 07906820082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Rx AP 100MG/5ML (20MG/ML) INJECTABLE INJECTION Rx AP - IRINOTECAN HYDROCHLORIDEPLIVA LACHEMAANDA 07812220082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Discontinued — 100MG/5ML (20MG/ML) INJECTABLE INJECTION Discontinued — - IRINOTECAN HYDROCHLORIDESUN PHARMA GLOBALANDA 07880520082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Discontinued — 100MG/5ML (20MG/ML) INJECTABLE INJECTION Discontinued — - IRINOTECAN HYDROCHLORIDEACTAVIS TOTOWAANDA 07858920083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Rx AP 100MG/5ML (20MG/ML) INJECTABLE INJECTION Rx AP 500MG/25ML (20MG/ML) INJECTABLE INJECTION Rx AP - IRINOTECAN HYDROCHLORIDEFRESENIUS KABI USAANDA 07777620082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Rx AP 100MG/5ML (20MG/ML) INJECTABLE INJECTION Rx AP - IRINOTECAN HYDROCHLORIDEFRESENIUS KABI USAANDA 07818820082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Discontinued — 100MG/5ML (20MG/ML) INJECTABLE INJECTION Discontinued — - IRINOTECAN HYDROCHLORIDEHOSPIRAANDA 07791520082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Rx AP 100MG/5ML (20MG/ML) INJECTABLE INJECTION Rx AP - IRINOTECAN HYDROCHLORIDERSHOSPIRAANDA 0787962008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/25ML (20MG/ML) INJECTABLE INJECTION Rx AP - IRINOTECAN HYDROCHLORIDESANDOZANDA 07799420082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Discontinued — 100MG/5ML (20MG/ML) INJECTABLE INJECTION Discontinued — - IRINOTECAN HYDROCHLORIDETEVA PHARMS USAANDA 09010120083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 500MG/25ML (20MG/ML) INJECTABLE INJECTION Rx AP 40MG/2ML (20MG/ML) INJECTABLE INJECTION Discontinued — 100MG/5ML (20MG/ML) INJECTABLE INJECTION Discontinued — - IRINOTECAN HYDROCHLORIDECIPLA LTDANDA 07721920082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40MG/2ML (20MG/ML) INJECTABLE INJECTION Discontinued — 100MG/5ML (20MG/ML) INJECTABLE INJECTION Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- I-932New indication exclusivity (3 years)
in 4 mo
- ODE-463Orphan-drug exclusivity (7 years)
in 4 yr 5 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8329213 | in 3 mo | SubstanceProduct | |
| 8147867 | in 1 yr 11 mo | SubstanceProduct | |
| 9717724 | in 6 yr 9 mo | U-2091 | |
| 9492442 | in 6 yr 9 mo | U-1917 | |
| 9364473 | in 6 yr 9 mo | U-1856 | |
| 12364691 | in 6 yr 9 mo | U-1848 | |
| 11369597 | in 6 yr 9 mo | U-1848 | |
| 9339497 | in 6 yr 9 mo | U-1848 | |
| 9452162 | in 6 yr 9 mo | U-1899 | |
| 10980795 | in 6 yr 9 mo | U-1848 | |
| 11344552 | in 10 yr | U-3824 | |
| 12059497 | in 10 yr 2 mo | Product | |
| 10456360 | in 10 yr 2 mo | Product | |
| 10993914 | in 10 yr 2 mo | Product |
Approval history
FDA approval span
First approval
30 yr 9 mo ago
Most recent approval
4 yr 7 mo ago
Approvals span 1996–2022 across 28 FDA applications.
Brand (NDA) 27%
Generic (ANDA) 2693%
Irinotecan hydrochloride: 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.
