Drybench Patent.

TENOFOVIR ALAFENAMIDE FUMARATE, NDA 208464

The patents and exclusivities FDA's Orange Book lists for NDA 208464 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 TENOFOVIR ALAFENAMIDE FUMARATE in the molecule app

Listed protection

Listed dates run from 27 Mar 2027 to 15 Feb 2033, each by its own rule; no one date stands for this product.

Earliest listed date: 27 Mar 2027NPP exclusivityRule R3 · Product 001 · exclusivity.txt line 711
Latest listed date: 15 Feb 2033US 9,296,769 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 8,663
Latest substance patent: 15 Feb 2033US 9,296,769 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 8,663
Latest listed patent: 15 Feb 2033US 9,296,769 with pediatric exclusivity, as listedRule R2 · Product 001 · patent.txt line 8,663
Latest exclusivity: 27 Mar 2027NPP exclusivityRule R3 · Product 001 · exclusivity.txt line 711

6 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 208464, as listed. The sections below name products by these numbers.

Product 001 · VEMLIDY
Dosage form; route
TABLET;ORAL
Strength
EQ 25MG BASE
Approval date as listed
10 Nov 2016
Type as listed
RX
Applicant as listed
GILEAD SCIENCES 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.

8 entries from 8 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 8,754,065, substance and product and use patent
patent.txt line 8,660
Expiry as listed
15 Aug 2032
Rule
R1
Flags
substance · product · use code U-1275
Product numbers
001
US 8,754,065, substance and product and use patent
patent.txt line 8,661
Expiry as listed
15 Aug 2032
Rule
R1
Flags
substance · product · use code U-3880
Product numbers
001
US 8,754,065, substance and product and use patent
patent.txt line 8,662
Expiry as listed
15 Aug 2032
Rule
R1
Flags
substance · product · use code U-999
Product numbers
001
US 9,296,769, substance and product and use patent
patent.txt line 8,664
Expiry as listed
15 Aug 2032
Rule
R1
Flags
substance · product · use code U-1275
Product numbers
001
US 9,296,769, substance and product and use patent
patent.txt line 8,665
Expiry as listed
15 Aug 2032
Rule
R1
Flags
substance · product · use code U-3880
Product numbers
001
US 9,296,769, substance and product and use patent
patent.txt line 8,666
Expiry as listed
15 Aug 2032
Rule
R1
Flags
substance · product · use code U-999
Product numbers
001
US 8,754,065 with pediatric exclusivity, as listed
patent.txt line 8,659
Expiry as listed
15 Feb 2033
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001
US 9,296,769 with pediatric exclusivity, as listed
patent.txt line 8,663
Expiry as listed
15 Feb 2033
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001

Listed exclusivities

Each exclusivity FDA lists for NDA 208464, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

NPP exclusivity
exclusivity.txt line 711
Date
27 Mar 2027
Rule
R3
Definition
New patient population (to be checked against FDA's list)
Product numbers
001

Paragraph IV list rows giving NDA 208464

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 208464, 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 208464

Tenofovir Alafenamide Fumarate · Tablets · 25 mg
RLD/NDA as listed: Vemlidy 208464
First PIV submission
5 Nov 2019
ANDAs
6
180-day status
Eligible
Decision posted
18 Apr 2023
First applicant approval
30 Mar 2023
First marketing
blank
Last qualifying patent expiry (as listed by FDA)
15 Aug 2032

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