Drybench Patent.
POMALIDOMIDE, NDA 204026
The patents and exclusivities FDA's Orange Book lists for NDA 204026 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 14 May 2027 to 21 Dec 2031, each by its own rule; no one date stands for this product.
- Earliest listed date
- 14 May 2027ODE-296 exclusivityRule R3 · Products 001, 002, 003, 004 · exclusivity.txt lines 348, 352, 356, 360
- Latest listed date
- 21 Dec 2031US 8,828,427 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 4,198, 4,204, 4,210, 4,216
- Latest substance patent
- 21 Dec 2031US 8,828,427 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 4,198, 4,204, 4,210, 4,216
- Latest listed patent
- 21 Dec 2031US 8,828,427 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 4,198, 4,204, 4,210, 4,216
- Latest exclusivity
- 14 Nov 2027PED exclusivityRule R3 · Products 001, 002, 003, 004 · exclusivity.txt lines 350–351, 354–355, 358–359, 362–363
Products
Each product number FDA lists under NDA 204026, as listed. The sections below name products by these numbers.
Product 001 · POMALYST
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 1MG
- Approval date as listed
- 8 Feb 2013
- Type as listed
- RX
- Applicant as listed
- BRISTOL MYERS SQUIBB CO
Product 002 · POMALYST
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 2MG
- Approval date as listed
- 8 Feb 2013
- Type as listed
- RX
- Applicant as listed
- BRISTOL MYERS SQUIBB CO
Product 003 · POMALYST
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 3MG
- Approval date as listed
- 8 Feb 2013
- Type as listed
- RX
- Applicant as listed
- BRISTOL MYERS SQUIBB CO
Product 004 · POMALYST
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 4MG
- Approval date as listed
- 8 Feb 2013
- Type as listed
- RX
- Applicant as listed
- BRISTOL MYERS SQUIBB CO
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.
6 entries from 24 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 10,555,939, product patent
patent.txt lines 4,197, 4,203, 4,209, 4,215- Expiry as listed
- 19 May 2030
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004
US 9,993,467, product patent
patent.txt lines 4,201, 4,207, 4,213, 4,219- Expiry as listed
- 19 May 2030
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004
US 10,555,939 with pediatric exclusivity, as listed
patent.txt lines 4,196, 4,202, 4,208, 4,214- Expiry as listed
- 19 Nov 2030
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 9,993,467 with pediatric exclusivity, as listed
patent.txt lines 4,200, 4,206, 4,212, 4,218- Expiry as listed
- 19 Nov 2030
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 8,828,427, substance and product patent
patent.txt lines 4,199, 4,205, 4,211, 4,217- Expiry as listed
- 21 Jun 2031
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003, 004
US 8,828,427 with pediatric exclusivity, as listed
patent.txt lines 4,198, 4,204, 4,210, 4,216- Expiry as listed
- 21 Dec 2031
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
Listed exclusivities
Each exclusivity FDA lists for NDA 204026, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
ODE-296 exclusivity
exclusivity.txt lines 348, 352, 356, 360- Date
- 14 May 2027
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
ODE-297 exclusivity
exclusivity.txt lines 349, 353, 357, 361- Date
- 14 May 2027
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
PED exclusivity
exclusivity.txt lines 350–351, 354–355, 358–359, 362–363- Date
- 14 Nov 2027
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
Paragraph IV list rows giving NDA 204026
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 204026, 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 204026
Pomalidomide · Capsules · 1 mg, 2 mg, 3 mg and 4 mg
RLD/NDA as listed: Pomalyst 204026- First PIV submission
- 8 Feb 2017
- ANDAs
- 6
- 180-day status
- Non-Forfeiture Deferred
- Decision posted
- 12/14/2021 1/12/2021
- First applicant approval
- 3 Oct 2020
- First marketing
- 2 Mar 2026
- Last qualifying patent expiry (as listed by FDA)
- 21 Jun 2031
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