Drybench Patent.
KETOROLAC TROMETHAMINE, NDA 021528
The patents and exclusivities FDA's Orange Book lists for NDA 021528 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. 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 24 May 2027 to 24 Nov 2027, each by its own rule; no one date stands for this product.
- Earliest listed date
- 24 May 2027US 8,008,338, substance and product and use patentRule R1 · Product 001 · patent.txt line 622
- Latest listed date
- 24 Nov 2027US 8,008,338 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 621
- Latest substance patent
- 24 Nov 2027US 8,008,338 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 621
- Latest listed patent
- 24 Nov 2027US 8,008,338 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 621
- Latest exclusivity
- None listed
1 use-code patent, blocking the coded use only
Products
Each product number FDA lists under NDA 021528, as listed. The sections below name products by these numbers.
Product 001 · ACULAR LS
- Dosage form; route
- SOLUTION/DROPS;OPHTHALMIC
- Strength
- 0.4%
- Approval date as listed
- 30 May 2003
- Type as listed
- RX
- Applicant as listed
- ABBVIE 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.
2 entries from 2 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 8,008,338, substance and product and use patent
patent.txt line 622- Expiry as listed
- 24 May 2027
- Rule
- R1
- Flags
- substance · product · use code U-1181
- Product numbers
- 001
US 8,008,338 with pediatric exclusivity, as listed
patent.txt line 621- Expiry as listed
- 24 Nov 2027
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
Listed exclusivities
Each exclusivity FDA lists for NDA 021528, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
The Orange Book capture of 14 October 2026 lists no exclusivity for NDA 021528.
Paragraph IV list rows giving NDA 021528
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 021528, each cell as listed.
FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.
The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.
Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.
Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 021528
Ketorolac Tromethamine · Ophthalmic Solution · 0.4%
RLD/NDA as listed: Acular LS 21528- First PIV submission
- 28 Jan 2005
- ANDAs
- 1
- 180-day status
- Extinguished
- Decision posted
- 29 Jun 2020
- First applicant approval
- 5 Nov 2009
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 5 May 2011
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