Drybench Patent.

FENFLURAMINE HYDROCHLORIDE, NDA 212102

The patents and exclusivities FDA's Orange Book lists for NDA 212102 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.

Open in the app FENFLURAMINE HYDROCHLORIDE in the molecule app

Listed protection

Listed dates run from 25 Jun 2027 to 29 Dec 2038, each by its own rule; no one date stands for this product.

Earliest listed date: 25 Jun 2027ODE-312 exclusivityRule R3 · Product 001 · exclusivity.txt line 1,021
Latest listed date: 29 Dec 2038US 10,452,815 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 13,549
Latest substance patent: 20 Jun 2037US 10,947,183 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 13,558
Latest listed patent: 29 Dec 2038US 10,452,815 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 13,549
Latest exclusivity: 25 Sep 2029PED exclusivityRule R3 · Product 001 · exclusivity.txt line 1,024

1 patent with a delist request, kept in the table · 16 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 212102, as listed. The sections below name products by these numbers.

Product 001 · FINTEPLA
Dosage form; route
SOLUTION;ORAL
Strength
EQ 2.2MG BASE/ML
Approval date as listed
25 Jun 2020
Type as listed
RX
Applicant as listed
UCB 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.

31 entries from 31 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 10,478,441, use patent
patent.txt line 13,552
Expiry as listed
3 May 2033
Rule
R1
Flags
use code U-2860
Product numbers
001
US 10,478,442, use patent
patent.txt line 13,554
Expiry as listed
3 May 2033
Rule
R1
Flags
use code U-2860
Product numbers
001
US 12,097,206, use patent
patent.txt line 13,571
Expiry as listed
3 May 2033
Rule
R1
Flags
use code U-4013
Product numbers
001
US 9,549,909, use patent
patent.txt line 13,573
Expiry as listed
3 May 2033
Rule
R1
Flags
use code U-2858
Product numbers
001
US 9,603,814, use patent
patent.txt line 13,575
Expiry as listed
3 May 2033
Rule
R1
Flags
use code U-2858
Product numbers
001
US 9,603,815, use patent
patent.txt line 13,577
Expiry as listed
3 May 2033
Rule
R1
Flags
use code U-2858
Product numbers
001
US 9,610,260, use patent
patent.txt line 13,579
Expiry as listed
3 May 2033
Rule
R1
Flags
use code U-2858
Product numbers
001
US 10,478,441 with pediatric exclusivity, as listed
patent.txt line 13,551
Expiry as listed
3 Nov 2033
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
US 10,478,442 with pediatric exclusivity, as listed
patent.txt line 13,553
Expiry as listed
3 Nov 2033
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
US 12,097,206 with pediatric exclusivity, as listed
patent.txt line 13,570
Expiry as listed
3 Nov 2033
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
US 9,549,909 with pediatric exclusivity, as listed
patent.txt line 13,572
Expiry as listed
3 Nov 2033
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
US 9,603,814 with pediatric exclusivity, as listed
patent.txt line 13,574
Expiry as listed
3 Nov 2033
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
US 9,603,815 with pediatric exclusivity, as listed
patent.txt line 13,576
Expiry as listed
3 Nov 2033
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
US 9,610,260 with pediatric exclusivity, as listed
patent.txt line 13,578
Expiry as listed
3 Nov 2033
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
US 10,947,183, substance and product patent
patent.txt line 13,559
Expiry as listed
20 Dec 2036
Rule
R1
Flags
substance · product
Product numbers
001
US 10,947,183 with pediatric exclusivity, as listed
patent.txt line 13,558
Expiry as listed
20 Jun 2037
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001
US 10,603,290, use patent
patent.txt line 13,556
Expiry as listed
2 Aug 2037
Rule
R1
Flags
use code U-2861
Product numbers
001
US 10,603,290, use patent
patent.txt line 13,557
Expiry as listed
2 Aug 2037
Rule
R1
Flags
use code U-3347
Product numbers
001
US 11,040,018, use patent
patent.txt line 13,561
Expiry as listed
2 Aug 2037
Rule
R1
Flags
use code U-2861
Product numbers
001
US 11,040,018, use patent
patent.txt line 13,562
Expiry as listed
2 Aug 2037
Rule
R1
Flags
use code U-3347
Product numbers
001
US 11,406,606, use patent
patent.txt line 13,564
Expiry as listed
2 Aug 2037
Rule
R1
Flags
use code U-3406
Product numbers
001
US 11,406,606, use patent
patent.txt line 13,565
Expiry as listed
2 Aug 2037
Rule
R1
Flags
use code U-3407
Product numbers
001
US 11,759,440, use patent
patent.txt line 13,567
Expiry as listed
2 Aug 2037
Rule
R1
Flags
use code U-3694
Product numbers
001
US 11,786,487, use patent
patent.txt line 13,569
Expiry as listed
2 Aug 2037
Rule
R1
Flags
use code U-3733
Product numbers
001
US 10,603,290 with pediatric exclusivity, as listed
patent.txt line 13,555
Expiry as listed
2 Feb 2038
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
US 11,040,018 with pediatric exclusivity, as listed
patent.txt line 13,560
Expiry as listed
2 Feb 2038
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
US 11,406,606 with pediatric exclusivity, as listed
patent.txt line 13,563
Expiry as listed
2 Feb 2038
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
US 11,759,440 with pediatric exclusivity, as listed
patent.txt line 13,566
Expiry as listed
2 Feb 2038
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
US 11,786,487 with pediatric exclusivity, as listed
patent.txt line 13,568
Expiry as listed
2 Feb 2038
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001
US 10,452,815, use patent
patent.txt line 13,550
Expiry as listed
29 Jun 2038
Rule
R1
Flags
use code U-2859 · delist requested
Product numbers
001
US 10,452,815 with pediatric exclusivity, as listed
patent.txt line 13,549
Expiry as listed
29 Dec 2038
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001

Listed exclusivities

Each exclusivity FDA lists for NDA 212102, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

ODE-312 exclusivity
exclusivity.txt line 1,021
Date
25 Jun 2027
Rule
R3
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
PED exclusivity
exclusivity.txt line 1,023
Date
25 Dec 2027
Rule
R3
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001
ODE-393 exclusivity
exclusivity.txt line 1,022
Date
25 Mar 2029
Rule
R3
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
PED exclusivity
exclusivity.txt line 1,024
Date
25 Sep 2029
Rule
R3
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001

Paragraph IV list rows giving NDA 212102

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 212102, 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 212102

Fenfluramine Hydrochloride · Oral Solution · 2.2 mg/mL
RLD/NDA as listed: Fintepla 212102
First PIV submission
21 Jun 2021
ANDAs
1
180-day status
blank
Decision posted
blank
First applicant approval
blank
First marketing
blank
Last qualifying patent expiry (as listed by FDA)
29 Jun 2038

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 exclusivity How to read the Orange Book data files Paragraph IV certification What changed, by week