Drybench Patent.
IRINOTECAN HYDROCHLORIDE, NDA 207793
The patents and exclusivities FDA's Orange Book lists for NDA 207793 as captured on 14 October 2026, each date named by its rule and its rows, and any rows of FDA's Paragraph IV list captured on 17 October 2026 that give this NDA's number. Listed protection is a range of dates, never one date.
FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.
- Orange Book captured
- 14 October 2026
- Paragraph IV list captured
- 17 October 2026
- Last checked
- 30 October 2026
- Data-branch commit
- dadcab56563716abea6c5e31a5e1970080c778ef
Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.
Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.
Listed protection
Listed dates run from 6 Jan 2027 to 15 Oct 2036, each by its own rule; no one date stands for this product.
- Earliest listed date
- 6 Jan 2027US 8,329,213, substance and product patentRule R1 · Product 001
Source lines
patent.txt line 7,423
- Latest listed date
- 15 Oct 2036US 12,059,497, product patentRule R1 · Product 001
Source lines
patent.txt line 7,420
- Latest substance patent
- 29 Aug 2028US 8,147,867, substance and product patentRule R1 · Product 001
Source lines
patent.txt line 7,422
- Latest listed patent
- 15 Oct 2036US 12,059,497, product patentRule R1 · Product 001
Source lines
patent.txt line 7,420
- Latest exclusivity
- 13 Feb 2031ODE-463 exclusivityRule R3 · Product 001
Source lines
exclusivity.txt line 625
Listed dates of other NDAs in the same years:20272028203120332036
12 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 207793, as listed. The sections below name products by these numbers.
Product 001 · ONIVYDE
- Dosage form; route
- INJECTABLE, LIPOSOMAL;
INTRAVENOUS - Strength
- EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML)
- Approval date as listed
- 22 Oct 2015
- Type as listed
- RX
- Applicant as listed
- IPSEN BIOPHARMACEUTICALS INC
Listed patents
Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.
17 entries from 17 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 8,329,213, substance and product patent
patent.txt line 7,423- Expiry as listed
- 6 Jan 2027
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001
US 8,147,867, substance and product patent
patent.txt line 7,422- Expiry as listed
- 29 Aug 2028
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001
US 10,980,795, use patent
patent.txt line 7,416- Expiry as listed
- 12 Jun 2033
- Rule
- R1
- Flags
- use code U-1848
- Product numbers
- 001
US 11,369,597, use patent
patent.txt line 7,419- Expiry as listed
- 12 Jun 2033
- Rule
- R1
- Flags
- use code U-1848
- Product numbers
- 001
US 12,364,691, use patent
patent.txt line 7,421- Expiry as listed
- 12 Jun 2033
- Rule
- R1
- Flags
- use code U-1848
- Product numbers
- 001
US 9,339,497, use patent
patent.txt line 7,424- Expiry as listed
- 12 Jun 2033
- Rule
- R1
- Flags
- use code U-1848
- Product numbers
- 001
US 9,364,473, use patent
patent.txt line 7,425- Expiry as listed
- 12 Jun 2033
- Rule
- R1
- Flags
- use code U-1856
- Product numbers
- 001
US 9,452,162, use patent
patent.txt line 7,426- Expiry as listed
- 12 Jun 2033
- Rule
- R1
- Flags
- use code U-1899
- Product numbers
- 001
US 9,492,442, use patent
patent.txt line 7,427- Expiry as listed
- 12 Jun 2033
- Rule
- R1
- Flags
- use code U-1848
- Product numbers
- 001
US 9,492,442, use patent
patent.txt line 7,428- Expiry as listed
- 12 Jun 2033
- Rule
- R1
- Flags
- use code U-1899
- Product numbers
- 001
US 9,492,442, use patent
patent.txt line 7,429- Expiry as listed
- 12 Jun 2033
- Rule
- R1
- Flags
- use code U-1917
- Product numbers
- 001
US 9,717,724, use patent
patent.txt line 7,430- Expiry as listed
- 12 Jun 2033
- Rule
- R1
- Flags
- use code U-1848
- Product numbers
- 001
US 9,717,724, use patent
patent.txt line 7,431- Expiry as listed
- 12 Jun 2033
- Rule
- R1
- Flags
- use code U-2091
- Product numbers
- 001
US 11,344,552, use patent
patent.txt line 7,418- Expiry as listed
- 19 Aug 2036
- Rule
- R1
- Flags
- use code U-3824
- Product numbers
- 001
US 10,456,360, product patent
patent.txt line 7,415- Expiry as listed
- 15 Oct 2036
- Rule
- R1
- Flags
- product
- Product numbers
- 001
US 10,993,914, product patent
patent.txt line 7,417- Expiry as listed
- 15 Oct 2036
- Rule
- R1
- Flags
- product
- Product numbers
- 001
US 12,059,497, product patent
patent.txt line 7,420- Expiry as listed
- 15 Oct 2036
- Rule
- R1
- Flags
- product
- Product numbers
- 001
Listed exclusivities
Each exclusivity FDA lists for NDA 207793, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
I-932 exclusivity
exclusivity.txt line 624- Date
- 13 Feb 2027
- Rule
- R3
- Definition
- New indication (to be checked against FDA's list)
- Product numbers
- 001
ODE-463 exclusivity
exclusivity.txt line 625- Date
- 13 Feb 2031
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001
Paragraph IV list rows giving NDA 207793
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 207793, each cell as listed.
Rows with no NDA number this page can match are kept apart on the list page; some may concern this product.
No row of the Paragraph IV list captured on 17 October 2026 gives NDA 207793 in its RLD/NDA cell. This does not mean no certification was submitted or that no application challenges a patent listed here.
Notes from the trace
- R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.
Patents vs FDA exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week