Drybench Patent.
REMDESIVIR, NDA 214787
The patents and exclusivities FDA's Orange Book lists for NDA 214787 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 22 Oct 2025 to 28 Nov 2041, each by its own rule; no one date stands for this product.
- Earliest listed date
- 22 Oct 2025NCE exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 1,392, 1,398
- Latest listed date
- 28 Nov 2041US 11,975,012 with pediatric exclusivity, as listedRule R2 · Products 001, 002 · patent.txt lines 16,145, 16,179
- Latest substance patent
- 29 Apr 2036US 9,949,994 with pediatric exclusivity, as listedRule R2 · Products 001, 002 · patent.txt lines 16,156, 16,188
- Latest listed patent
- 28 Nov 2041US 11,975,012 with pediatric exclusivity, as listedRule R2 · Products 001, 002 · patent.txt lines 16,145, 16,179
- Latest exclusivity
- 28 Aug 2027PED exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 1,395, 1,401
26 use-code patents, blocking the coded use only
This page shows only the dates FDA lists. The app also shows NCE-1, the one date it computes, with its qualifications. Open in the app
Products
Each product number FDA lists under NDA 214787, as listed. The sections below name products by these numbers.
Product 001 · VEKLURY
- Dosage form; route
- POWDER;INTRAVENOUS
- Strength
- 100MG/VIAL
- Approval date as listed
- 22 Oct 2020
- Type as listed
- RX
- Applicant as listed
- GILEAD SCIENCES INC
Product 002 · VEKLURY
- Dosage form; route
- SOLUTION;INTRAVENOUS
- Strength
- 100MG/20ML (5MG/ML)
- Approval date as listed
- 22 Oct 2020
- Type as listed
- DISCN
- 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.
51 entries from 71 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 8,318,682, substance and product patent
patent.txt lines 16,153, 16,185- Expiry as listed
- 22 Apr 2029
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US RE46762, substance and product patent
patent.txt lines 16,159, 16,191- Expiry as listed
- 22 Apr 2029
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 8,008,264, substance and product patent
patent.txt lines 16,151, 16,183- Expiry as listed
- 6 Sep 2029
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 8,318,682 with pediatric exclusivity, as listed
patent.txt lines 16,152, 16,184- Expiry as listed
- 22 Oct 2029
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US RE46762 with pediatric exclusivity, as listed
patent.txt lines 16,158, 16,190- Expiry as listed
- 22 Oct 2029
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,008,264 with pediatric exclusivity, as listed
patent.txt lines 16,150, 16,182- Expiry as listed
- 6 Mar 2030
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 11,492,353, substance patent
patent.txt lines 16,141, 16,175- Expiry as listed
- 8 Dec 2031
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002
US 11,492,353 with pediatric exclusivity, as listed
patent.txt lines 16,140, 16,174- Expiry as listed
- 8 Jun 2032
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,065,958, substance patent
patent.txt lines 16,122, 16,161- Expiry as listed
- 18 Nov 2032
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002
US 10,065,958 with pediatric exclusivity, as listed
patent.txt lines 16,121, 16,160- Expiry as listed
- 18 May 2033
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 9,724,360, substance and product patent
patent.txt lines 16,155, 16,187- Expiry as listed
- 29 Oct 2035
- Rule
- R1
- Flags
- substance · product
- Product numbers
- 001, 002
US 9,949,994, substance patent
patent.txt lines 16,157, 16,189- Expiry as listed
- 29 Oct 2035
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002
US 9,724,360 with pediatric exclusivity, as listed
patent.txt lines 16,154, 16,186- Expiry as listed
- 29 Apr 2036
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 9,949,994 with pediatric exclusivity, as listed
patent.txt lines 16,156, 16,188- Expiry as listed
- 29 Apr 2036
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,695,361, use patent
patent.txt line 16,126- Expiry as listed
- 16 Sep 2036
- Rule
- R1
- Flags
- use code U-3831
- Product numbers
- 001
US 10,695,361, use patent
patent.txt line 16,127- Expiry as listed
- 16 Sep 2036
- Rule
- R1
- Flags
- use code U-3832
- Product numbers
- 001
US 10,695,361, use patent
patent.txt line 16,163- Expiry as listed
- 16 Sep 2036
- Rule
- R1
- Flags
- use code U-3829
- Product numbers
- 002
US 10,695,361, use patent
patent.txt line 16,164- Expiry as listed
- 16 Sep 2036
- Rule
- R1
- Flags
- use code U-3830
- Product numbers
- 002
US 11,007,208, use patent
patent.txt line 16,129- Expiry as listed
- 16 Sep 2036
- Rule
- R1
- Flags
- use code U-3831
- Product numbers
- 001
US 11,007,208, use patent
patent.txt line 16,130- Expiry as listed
- 16 Sep 2036
- Rule
- R1
- Flags
- use code U-3832
- Product numbers
- 001
US 11,007,208, use patent
patent.txt line 16,166- Expiry as listed
- 16 Sep 2036
- Rule
- R1
- Flags
- use code U-3829
- Product numbers
- 002
US 11,007,208, use patent
patent.txt line 16,167- Expiry as listed
- 16 Sep 2036
- Rule
- R1
- Flags
- use code U-3830
- Product numbers
- 002
US 11,382,926, use patent
patent.txt line 16,135- Expiry as listed
- 16 Sep 2036
- Rule
- R1
- Flags
- use code U-3831
- Product numbers
- 001
US 11,382,926, use patent
patent.txt line 16,136- Expiry as listed
- 16 Sep 2036
- Rule
- R1
- Flags
- use code U-3832
- Product numbers
- 001
US 11,382,926, use patent
patent.txt line 16,169- Expiry as listed
- 16 Sep 2036
- Rule
- R1
- Flags
- use code U-3829
- Product numbers
- 002
US 11,382,926, use patent
patent.txt line 16,170- Expiry as listed
- 16 Sep 2036
- Rule
- R1
- Flags
- use code U-3830
- Product numbers
- 002
US 10,695,361 with pediatric exclusivity, as listed
patent.txt lines 16,125, 16,162- Expiry as listed
- 16 Mar 2037
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 11,007,208 with pediatric exclusivity, as listed
patent.txt lines 16,128, 16,165- Expiry as listed
- 16 Mar 2037
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 11,382,926 with pediatric exclusivity, as listed
patent.txt lines 16,134, 16,168- Expiry as listed
- 16 Mar 2037
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 10,675,296, product patent
patent.txt line 16,124- Expiry as listed
- 10 Jul 2038
- Rule
- R1
- Flags
- product
- Product numbers
- 001
US 11,266,681, use patent
patent.txt line 16,132- Expiry as listed
- 10 Jul 2038
- Rule
- R1
- Flags
- use code U-3831
- Product numbers
- 001
US 11,266,681, use patent
patent.txt line 16,133- Expiry as listed
- 10 Jul 2038
- Rule
- R1
- Flags
- use code U-3832
- Product numbers
- 001
US 11,975,017, product patent
patent.txt line 16,149- Expiry as listed
- 10 Jul 2038
- Rule
- R1
- Flags
- product
- Product numbers
- 001
US 10,675,296 with pediatric exclusivity, as listed
patent.txt line 16,123- Expiry as listed
- 10 Jan 2039
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
US 11,266,681 with pediatric exclusivity, as listed
patent.txt line 16,131- Expiry as listed
- 10 Jan 2039
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
US 11,975,017 with pediatric exclusivity, as listed
patent.txt line 16,148- Expiry as listed
- 10 Jan 2039
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001
US 11,491,169, use patent
patent.txt line 16,138- Expiry as listed
- 28 May 2041
- Rule
- R1
- Flags
- use code U-3835
- Product numbers
- 001
US 11,491,169, use patent
patent.txt line 16,139- Expiry as listed
- 28 May 2041
- Rule
- R1
- Flags
- use code U-3836
- Product numbers
- 001
US 11,491,169, use patent
patent.txt line 16,172- Expiry as listed
- 28 May 2041
- Rule
- R1
- Flags
- use code U-3833
- Product numbers
- 002
US 11,491,169, use patent
patent.txt line 16,173- Expiry as listed
- 28 May 2041
- Rule
- R1
- Flags
- use code U-3834
- Product numbers
- 002
US 11,903,953, use patent
patent.txt line 16,143- Expiry as listed
- 28 May 2041
- Rule
- R1
- Flags
- use code U-3835
- Product numbers
- 001
US 11,903,953, use patent
patent.txt line 16,144- Expiry as listed
- 28 May 2041
- Rule
- R1
- Flags
- use code U-3836
- Product numbers
- 001
US 11,903,953, use patent
patent.txt line 16,177- Expiry as listed
- 28 May 2041
- Rule
- R1
- Flags
- use code U-3833
- Product numbers
- 002
US 11,903,953, use patent
patent.txt line 16,178- Expiry as listed
- 28 May 2041
- Rule
- R1
- Flags
- use code U-3834
- Product numbers
- 002
US 11,975,012, use patent
patent.txt line 16,146- Expiry as listed
- 28 May 2041
- Rule
- R1
- Flags
- use code U-3835
- Product numbers
- 001
US 11,975,012, use patent
patent.txt line 16,147- Expiry as listed
- 28 May 2041
- Rule
- R1
- Flags
- use code U-3836
- Product numbers
- 001
US 11,975,012, use patent
patent.txt line 16,180- Expiry as listed
- 28 May 2041
- Rule
- R1
- Flags
- use code U-3833
- Product numbers
- 002
US 11,975,012, use patent
patent.txt line 16,181- Expiry as listed
- 28 May 2041
- Rule
- R1
- Flags
- use code U-3834
- Product numbers
- 002
US 11,491,169 with pediatric exclusivity, as listed
patent.txt lines 16,137, 16,171- Expiry as listed
- 28 Nov 2041
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 11,903,953 with pediatric exclusivity, as listed
patent.txt lines 16,142, 16,176- Expiry as listed
- 28 Nov 2041
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 11,975,012 with pediatric exclusivity, as listed
patent.txt lines 16,145, 16,179- Expiry as listed
- 28 Nov 2041
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
Listed exclusivities
Each exclusivity FDA lists for NDA 214787, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
NCE exclusivity
exclusivity.txt lines 1,392, 1,398- Date
- 22 Oct 2025
- Rule
- R3
- Definition
- New chemical entity (to be checked against FDA's list)
- Product numbers
- 001, 002
PED exclusivity
exclusivity.txt lines 1,394, 1,400- Date
- 22 Apr 2026
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
M-301 exclusivity
exclusivity.txt lines 1,391, 1,397- Date
- 13 Jul 2026
- Rule
- R3
- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
PED exclusivity
exclusivity.txt lines 1,396, 1,402- Date
- 13 Jan 2027
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
NPP exclusivity
exclusivity.txt lines 1,393, 1,399- Date
- 28 Feb 2027
- Rule
- R3
- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
PED exclusivity
exclusivity.txt lines 1,395, 1,401- Date
- 28 Aug 2027
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
Paragraph IV list rows giving NDA 214787
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 214787, 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 214787
Remdesivir · Powder for Injection · 100 mg/vial
RLD/NDA as listed: Veklury 214787- First PIV submission
- 22 Apr 2025
- ANDAs
- 1
- 180-day status
- blank
- Decision posted
- blank
- First applicant approval
- blank
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 28 May 2041
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