Drybench Patent.
SELUMETINIB SULFATE, NDA 213756
The patents and exclusivities FDA's Orange Book lists for NDA 213756 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 13 Mar 2026 to 19 Nov 2032, each by its own rule; no one date stands for this product.
- Earliest listed date
- 13 Mar 2026US 8,178,693, substance and product patentRule R1 · Products 001, 002 · patent.txt lines 15,259, 15,267
- Latest listed date
- 19 Nov 2032ODE-545 exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 1,259, 1,263
- Latest substance patent
- 13 Mar 2028US 7,425,637, substance patentRule R1 · Products 001, 002 · patent.txt lines 15,258, 15,266
- Latest listed patent
- 26 Mar 2029US 12,364,684, use patentRule R1 · Products 001, 002 · patent.txt lines 15,257, 15,265
- Latest exclusivity
- 19 Nov 2032ODE-545 exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 1,259, 1,263
4 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 213756, as listed. The sections below name products by these numbers.
Product 001 · KOSELUGO
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 10MG BASE
- Approval date as listed
- 10 Apr 2020
- Type as listed
- RX
- Applicant as listed
- ASTRAZENECA PHARMACEUTICALS LP
Product 002 · KOSELUGO
- Dosage form; route
- CAPSULE;ORAL
- Strength
- EQ 25MG BASE
- Approval date as listed
- 10 Apr 2020
- Type as listed
- RX
- Applicant as listed
- ASTRAZENECA PHARMACEUTICALS LP
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.
8 entries from 16 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 8,178,693, substance and product patent
patent.txt lines 15,259, 15,267- Expiry as listed
- 13 Mar 2026
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 9,156,795, substance and product patent
patent.txt lines 15,260, 15,268- Expiry as listed
- 12 Dec 2026
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 9,562,017, substance and use patent
patent.txt lines 15,261, 15,269- Expiry as listed
- 12 Dec 2026
- Rule
- R1
- Flags
- substance · use code U-4357
- Product numbers
- 001, 002
US 7,425,637, substance patent
patent.txt lines 15,258, 15,266- Expiry as listed
- 13 Mar 2028
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002
US 11,813,246, product patent
patent.txt lines 15,254, 15,262- Expiry as listed
- 26 Mar 2029
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 12,220,403, product patent
patent.txt lines 15,255, 15,263- Expiry as listed
- 26 Mar 2029
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 12,318,367, product patent
patent.txt lines 15,256, 15,264- Expiry as listed
- 26 Mar 2029
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 12,364,684, use patent
patent.txt lines 15,257, 15,265- Expiry as listed
- 26 Mar 2029
- Rule
- R1
- Flags
- use code U-4357
- Product numbers
- 001, 002
Listed exclusivities
Each exclusivity FDA lists for NDA 213756, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
ODE-288 exclusivity
exclusivity.txt lines 1,258, 1,262- Date
- 10 Apr 2027
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
NPP exclusivity
exclusivity.txt lines 1,257, 1,261- Date
- 10 Sep 2028
- Rule
- R3
- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
NPP exclusivity
exclusivity.txt lines 1,256, 1,260- Date
- 19 Nov 2028
- Rule
- R3
- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
ODE-545 exclusivity
exclusivity.txt lines 1,259, 1,263- Date
- 19 Nov 2032
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
Paragraph IV list rows giving NDA 213756
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 213756, 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 213756
Selumetinib Sulfate · Capsules · 10 mg and 25 mg
RLD/NDA as listed: Koselugo 213756- First PIV submission
- 4 Aug 2026
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 26 Mar 2029
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