Drybench Patent.

SOFOSBUVIR; VELPATASVIR, NDA 214187

The patents and exclusivities FDA's Orange Book lists for NDA 214187 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.

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Listed protection

Listed dates run from 19 Mar 2027 to 30 Jul 2034, each by its own rule; no one date stands for this product.

Earliest listed date: 19 Mar 2027ODE* exclusivityRule R3 · Product 002
Source lines
exclusivity.txt line 1,313
Latest listed date: 30 Jul 2034US 11,707,479 with pediatric exclusivity, as listedRule R2 · Products 001, 002
Source lines
patent.txt lines 15,578, 15,606
Latest substance patent: 16 May 2033US 8,940,718 with pediatric exclusivity, as listedRule R2 · Products 001, 002
Source lines
patent.txt lines 15,598, 15,626
Latest listed patent: 30 Jul 2034US 11,707,479 with pediatric exclusivity, as listedRule R2 · Products 001, 002
Source lines
patent.txt lines 15,578, 15,606
Latest exclusivity: 10 Dec 2028PED exclusivityRule R3 · Product 001
Source lines
exclusivity.txt line 1,312

Listed dates of other NDAs in the same years:2027 2028 2029 2030 2031 2032 2033 2034

28 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 214187, as listed. The sections below name products by these numbers.

Product 001 · EPCLUSA
Dosage form; route
PELLETS;ORAL
Strength
150MG/PACKET;37.5MG/PACKET
Approval date as listed
10 Jun 2021
Type as listed
RX
Applicant as listed
GILEAD SCIENCES INC
Product 002 · EPCLUSA
Dosage form; route
PELLETS;ORAL
Strength
200MG/PACKET;50MG/PACKET
Approval date as listed
10 Jun 2021
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.

28 entries from 56 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 8,334,270, substance and product and use patent
patent.txt lines 15,583, 15,611
Expiry as listed
21 Mar 2028
Rule
R1
Flags
substance · product · use code U-1470
Product numbers
001, 002
US 8,580,765, substance and product and use patent
patent.txt lines 15,587, 15,615
Expiry as listed
21 Mar 2028
Rule
R1
Flags
substance · product · use code U-1470
Product numbers
001, 002
US 8,735,372, use patent
patent.txt lines 15,593, 15,621
Expiry as listed
21 Mar 2028
Rule
R1
Flags
use code U-1470
Product numbers
001, 002
US 9,085,573, substance and product and use patent
patent.txt lines 15,601, 15,629
Expiry as listed
21 Mar 2028
Rule
R1
Flags
substance · product · use code U-1470
Product numbers
001, 002
US 8,334,270 with pediatric exclusivity, as listed
patent.txt lines 15,582, 15,610
Expiry as listed
21 Sep 2028
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
US 8,580,765 with pediatric exclusivity, as listed
patent.txt lines 15,586, 15,614
Expiry as listed
21 Sep 2028
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
US 8,735,372 with pediatric exclusivity, as listed
patent.txt lines 15,592, 15,620
Expiry as listed
21 Sep 2028
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
US 9,085,573 with pediatric exclusivity, as listed
patent.txt lines 15,600, 15,628
Expiry as listed
21 Sep 2028
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
US 7,964,580, substance and product and use patent
patent.txt lines 15,581, 15,609
Expiry as listed
26 Mar 2029
Rule
R1
Flags
substance · product · use code U-1470
Product numbers
001, 002
US 8,633,309, substance and product and use patent
patent.txt lines 15,591, 15,619
Expiry as listed
26 Mar 2029
Rule
R1
Flags
substance · product · use code U-1470
Product numbers
001, 002
US 8,889,159, product and use patent
patent.txt lines 15,595, 15,623
Expiry as listed
26 Mar 2029
Rule
R1
Flags
product · use code U-1470
Product numbers
001, 002
US 7,964,580 with pediatric exclusivity, as listed
patent.txt lines 15,580, 15,608
Expiry as listed
26 Sep 2029
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
US 8,633,309 with pediatric exclusivity, as listed
patent.txt lines 15,590, 15,618
Expiry as listed
26 Sep 2029
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
US 8,889,159 with pediatric exclusivity, as listed
patent.txt lines 15,594, 15,622
Expiry as listed
26 Sep 2029
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
US 9,284,342, substance and product and use patent
patent.txt lines 15,603, 15,631
Expiry as listed
13 Sep 2030
Rule
R1
Flags
substance · product · use code U-1470
Product numbers
001, 002
US 8,618,076, substance and product and use patent
patent.txt lines 15,589, 15,617
Expiry as listed
11 Dec 2030
Rule
R1
Flags
substance · product · use code U-1470
Product numbers
001, 002
US 9,284,342 with pediatric exclusivity, as listed
patent.txt lines 15,602, 15,630
Expiry as listed
13 Mar 2031
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
US 8,618,076 with pediatric exclusivity, as listed
patent.txt lines 15,588, 15,616
Expiry as listed
11 Jun 2031
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
US 8,575,135, substance and product and use patent
patent.txt lines 15,585, 15,613
Expiry as listed
16 Nov 2032
Rule
R1
Flags
substance · product · use code U-1470
Product numbers
001, 002
US 8,921,341, substance and product and use patent
patent.txt lines 15,597, 15,625
Expiry as listed
16 Nov 2032
Rule
R1
Flags
substance · product · use code U-1470
Product numbers
001, 002
US 8,940,718, substance and product and use patent
patent.txt lines 15,599, 15,627
Expiry as listed
16 Nov 2032
Rule
R1
Flags
substance · product · use code U-1470
Product numbers
001, 002
US 8,575,135 with pediatric exclusivity, as listed
patent.txt lines 15,584, 15,612
Expiry as listed
16 May 2033
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
US 8,921,341 with pediatric exclusivity, as listed
patent.txt lines 15,596, 15,624
Expiry as listed
16 May 2033
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
US 8,940,718 with pediatric exclusivity, as listed
patent.txt lines 15,598, 15,626
Expiry as listed
16 May 2033
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
US 11,116,783, product and use patent
patent.txt lines 15,577, 15,605
Expiry as listed
30 Jan 2034
Rule
R1
Flags
product · use code U-1470
Product numbers
001, 002
US 11,707,479, product and use patent
patent.txt lines 15,579, 15,607
Expiry as listed
30 Jan 2034
Rule
R1
Flags
product · use code U-1470
Product numbers
001, 002
US 11,116,783 with pediatric exclusivity, as listed
patent.txt lines 15,576, 15,604
Expiry as listed
30 Jul 2034
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002
US 11,707,479 with pediatric exclusivity, as listed
patent.txt lines 15,578, 15,606
Expiry as listed
30 Jul 2034
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002

Listed exclusivities

Each exclusivity FDA lists for NDA 214187, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

ODE* exclusivity
exclusivity.txt line 1,313
Date
19 Mar 2027
Rule
R3
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
002
PED exclusivity
exclusivity.txt line 1,314
Date
19 Sep 2027
Rule
R3
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
002
ODE-376 exclusivity
exclusivity.txt line 1,311
Date
10 Jun 2028
Rule
R3
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001
PED exclusivity
exclusivity.txt line 1,312
Date
10 Dec 2028
Rule
R3
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001

Paragraph IV list rows giving NDA 214187

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 214187, 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 214187 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