Drybench Patent.

TESTOSTERONE UNDECANOATE, NDA 208088

The patents and exclusivities FDA's Orange Book lists for NDA 208088 as captured on 14 October 2026, each date named by its rule and its rows, and any rows of FDA's Paragraph IV list captured on 17 October 2026 that give this NDA's number. 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 TESTOSTERONE UNDECANOATE in the molecule app

Listed protection

Listed dates run from 8 Jan 2029 to 28 Apr 2041, each by its own rule; no one date stands for this product.

Earliest listed date: 8 Jan 2029US 11,304,960, product and use patentRule R1 · Product 001
Source lines
patent.txt line 8,209
Latest listed date: 28 Apr 2041US 12,691,057, product and use patentRule R1 · Product 001
Source lines
patent.txt line 8,218
Latest substance patent: None listed
Latest listed patent: 28 Apr 2041US 12,691,057, product and use patentRule R1 · Product 001
Source lines
patent.txt line 8,218
Latest exclusivity: None listed

Listed dates of other NDAs in the same years:2029 2030 2037 2039 2040 2041

16 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 208088, as listed. The sections below name products by these numbers.

Product 001 · TLANDO
Dosage form; route
CAPSULE;ORAL
Strength
112.5MG
Approval date as listed
28 Mar 2022
Type as listed
RX
Applicant as listed
VERITY PHARMACEUTICALS 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.

16 entries from 16 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 11,304,960, product and use patent
patent.txt line 8,209
Expiry as listed
8 Jan 2029
Rule
R1
Flags
product · use code U-1500
Product numbers
001
US 8,778,922, product and use patent
patent.txt line 8,219
Expiry as listed
8 Jan 2029
Rule
R1
Flags
product · use code U-1500
Product numbers
001
US 8,865,695, use patent
patent.txt line 8,220
Expiry as listed
8 Jan 2029
Rule
R1
Flags
use code U-1500
Product numbers
001
US 10,226,473, use patent
patent.txt line 8,207
Expiry as listed
30 Nov 2030
Rule
R1
Flags
use code U-1500
Product numbers
001
US 10,716,794, use patent
patent.txt line 8,208
Expiry as listed
30 Nov 2030
Rule
R1
Flags
use code U-1500
Product numbers
001
US 11,311,555, use patent
patent.txt line 8,210
Expiry as listed
30 Nov 2030
Rule
R1
Flags
use code U-1500
Product numbers
001
US 11,364,249, use patent
patent.txt line 8,211
Expiry as listed
30 Nov 2030
Rule
R1
Flags
use code U-1500
Product numbers
001
US 11,433,083, use patent
patent.txt line 8,212
Expiry as listed
30 Nov 2030
Rule
R1
Flags
use code U-1500
Product numbers
001
US 9,943,527, use patent
patent.txt line 8,221
Expiry as listed
30 Nov 2030
Rule
R1
Flags
use code U-1500
Product numbers
001
US 9,949,985, use patent
patent.txt line 8,222
Expiry as listed
30 Nov 2030
Rule
R1
Flags
use code U-1500
Product numbers
001
US 11,559,530, use patent
patent.txt line 8,214
Expiry as listed
28 Nov 2037
Rule
R1
Flags
use code U-1500
Product numbers
001
US 12,310,978, use patent
patent.txt line 8,217
Expiry as listed
21 Feb 2039
Rule
R1
Flags
use code U-4194
Product numbers
001
US 12,011,503, product and use patent
patent.txt line 8,215
Expiry as listed
16 Oct 2040
Rule
R1
Flags
product · use code U-3964
Product numbers
001
US 12,011,503, product and use patent
patent.txt line 8,216
Expiry as listed
16 Oct 2040
Rule
R1
Flags
product · use code U-3965
Product numbers
001
US 11,464,735, product and use patent
patent.txt line 8,213
Expiry as listed
28 Apr 2041
Rule
R1
Flags
product · use code U-1500
Product numbers
001
US 12,691,057, product and use patent
patent.txt line 8,218
Expiry as listed
28 Apr 2041
Rule
R1
Flags
product · use code U-4194
Product numbers
001

Listed exclusivities

Each exclusivity FDA lists for NDA 208088, 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 208088.

Paragraph IV list rows giving NDA 208088

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 208088, each cell as listed.

Rows with no NDA number this page can match are kept apart on the list page; some may concern this product.

No row of the Paragraph IV list captured on 17 October 2026 gives NDA 208088 in its RLD/NDA cell. This does not mean no certification was submitted or that no application challenges a patent listed here.

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