Drybench Patent.
LENALIDOMIDE, NDA 021880
The patents and exclusivities FDA's Orange Book lists for NDA 021880 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 28 May 2026 to 8 Mar 2028, each by its own rule; no one date stands for this product.
- Earliest listed date
- 28 May 2026ODE-241 exclusivityRule R3 · Products 001, 002, 003, 004, 005, 006 · exclusivity.txt lines 133, 135, 137, 139, 141, 143
- Latest listed date
- 8 Mar 2028US 8,741,929, use patentRule R1 · Products 001, 002, 003, 004, 005, 006 · patent.txt lines 750, 752, 754, 756, 758, 760
- Latest substance patent
- 27 Apr 2027US 7,465,800, substance and product patentRule R1 · Products 001, 002, 003, 004, 005, 006 · patent.txt lines 749, 751, 753, 755, 757, 759
- Latest listed patent
- 8 Mar 2028US 8,741,929, use patentRule R1 · Products 001, 002, 003, 004, 005, 006 · patent.txt lines 750, 752, 754, 756, 758, 760
- Latest exclusivity
- 28 May 2026ODE-245 exclusivityRule R3 · Products 001, 002, 003, 004, 005, 006 · exclusivity.txt lines 134, 136, 138, 140, 142, 144
6 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 021880, as listed. The sections below name products by these numbers.
Product 001 · REVLIMID
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 5MG
- Approval date as listed
- 27 Dec 2005
- Type as listed
- RX
- Applicant as listed
- BRISTOL MYERS SQUIBB
Product 002 · REVLIMID
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 10MG
- Approval date as listed
- 27 Dec 2005
- Type as listed
- RX
- Applicant as listed
- BRISTOL MYERS SQUIBB
Product 003 · REVLIMID
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 15MG
- Approval date as listed
- 29 Jun 2006
- Type as listed
- RX
- Applicant as listed
- BRISTOL MYERS SQUIBB
Product 004 · REVLIMID
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 25MG
- Approval date as listed
- 29 Jun 2006
- Type as listed
- RX
- Applicant as listed
- BRISTOL MYERS SQUIBB
Product 005 · REVLIMID
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 2.5MG
- Approval date as listed
- 21 Dec 2011
- Type as listed
- RX
- Applicant as listed
- BRISTOL MYERS SQUIBB
Product 006 · REVLIMID
- Dosage form; route
- CAPSULE;ORAL
- Strength
- 20MG
- Approval date as listed
- 5 Jun 2013
- Type as listed
- RX
- Applicant as listed
- BRISTOL MYERS SQUIBB
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 12 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 7,465,800, substance and product patent
patent.txt lines 749, 751, 753, 755, 757, 759- Expiry as listed
- 27 Apr 2027
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002, 003, 004, 005, 006
US 8,741,929, use patent
patent.txt lines 750, 752, 754, 756, 758, 760- Expiry as listed
- 8 Mar 2028
- Rule
- R1
- Flags
- use code U-1983
- Product numbers
- 001, 002, 003, 004, 005, 006
Listed exclusivities
Each exclusivity FDA lists for NDA 021880, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
ODE-241 exclusivity
exclusivity.txt lines 133, 135, 137, 139, 141, 143- Date
- 28 May 2026
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
ODE-245 exclusivity
exclusivity.txt lines 134, 136, 138, 140, 142, 144- Date
- 28 May 2026
- Rule
- R3
- Definition
- Orphan drug exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004, 005, 006
Paragraph IV list rows giving NDA 021880
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 021880, 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 021880
Lenalidomide · Capsules · 5 mg, 10 mg and 15 mg
RLD/NDA as listed: Revlimid 21880- First PIV submission
- 30 Aug 2010
- ANDAs
- 1
- 180-day status
- Non-Forfeiture
- Decision posted
- 17 Nov 2020
- First applicant approval
- 21 May 2021
- First marketing
- 3 Mar 2022
- Last qualifying patent expiry (as listed by FDA)
- 27 Apr 2027
Lenalidomide · Capsules · 2.5 mg and 20 mg
RLD/NDA as listed: Revlimid 21880- First PIV submission
- 12 Jul 2016
- ANDAs
- 1
- 180-day status
- Non-Forfeiture
- Decision posted
- 17 Nov 2020
- First applicant approval
- 14 Oct 2021
- First marketing
- 7 Sep 2022
- Last qualifying patent expiry (as listed by FDA)
- 27 Apr 2027
Lenalidomide · Capsules · 25 mg
RLD/NDA as listed: Revlimid 21880- First PIV submission
- 12 Jul 2010
- ANDAs
- 1
- 180-day status
- Non-Forfeiture
- Decision posted
- 17 Nov 2020
- First applicant approval
- 21 May 2021
- First marketing
- 3 Mar 2022
- Last qualifying patent expiry (as listed by FDA)
- 27 Apr 2027
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