Drybench Patent.
DAPAGLIFLOZIN, NDA 202293
The patents and exclusivities FDA's Orange Book lists for NDA 202293 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 4 Oct 2025 to 1 Oct 2041, each by its own rule; no one date stands for this product.
- Earliest listed date
- 4 Oct 2025US 6,515,117, substance and product and use patentRule R1 · Products 001, 002 · patent.txt lines 2,978, 3,016
- Latest listed date
- 1 Oct 2041US 12,409,186 with pediatric exclusivity, as listedRule R2 · Product 002 · patent.txt line 3,011
- Latest substance patent
- 16 Jun 2030US 7,919,598 with pediatric exclusivity, as listedRule R2 · Products 001, 002 · patent.txt lines 2,982, 3,020
- Latest listed patent
- 1 Oct 2041US 12,409,186 with pediatric exclusivity, as listedRule R2 · Product 002 · patent.txt line 3,011
- Latest exclusivity
- 12 Dec 2027PED exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 269, 273
2 patents with a delist request, kept in the table · 26 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 202293, as listed. The sections below name products by these numbers.
Product 001 · FARXIGA
- Dosage form; route
- TABLET;ORAL
- Strength
- 5MG
- Approval date as listed
- 8 Jan 2014
- Type as listed
- RX
- Applicant as listed
- ASTRAZENECA AB
Product 002 · FARXIGA
- Dosage form; route
- TABLET;ORAL
- Strength
- 10MG
- Approval date as listed
- 8 Jan 2014
- Type as listed
- RX
- Applicant as listed
- ASTRAZENECA AB
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.
38 entries from 64 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.
US 6,515,117, substance and product and use patent
patent.txt lines 2,978, 3,016- Expiry as listed
- 4 Oct 2025
- Rule
- R1
- Flags
- substance · product · use code U-2139
- Product numbers
- 001, 002
US 6,515,117, substance and product and use patent
patent.txt lines 2,979, 3,017- Expiry as listed
- 4 Oct 2025
- Rule
- R1
- Flags
- substance · product · use code U-493
- Product numbers
- 001, 002
US 6,515,117 with pediatric exclusivity, as listed
patent.txt lines 2,977, 3,015- Expiry as listed
- 4 Apr 2026
- Rule
- R2
- Flags
- substance · product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,329,648, use patent
patent.txt lines 2,987, 3,025- Expiry as listed
- 18 Aug 2026
- Rule
- R1
- Flags
- use code U-2139
- Product numbers
- 001, 002
US 8,329,648, use patent
patent.txt lines 2,988, 3,026- Expiry as listed
- 18 Aug 2026
- Rule
- R1
- Flags
- use code U-2212
- Product numbers
- 001, 002
US 8,329,648, use patent
patent.txt lines 2,989, 3,027- Expiry as listed
- 18 Aug 2026
- Rule
- R1
- Flags
- use code U-2213
- Product numbers
- 001, 002
US 8,906,851, use patent
patent.txt lines 3,002, 3,040- Expiry as listed
- 18 Aug 2026
- Rule
- R1
- Flags
- use code U-2139
- Product numbers
- 001, 002
US 8,329,648 with pediatric exclusivity, as listed
patent.txt lines 2,986, 3,024- Expiry as listed
- 18 Feb 2027
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,906,851 with pediatric exclusivity, as listed
patent.txt lines 3,001, 3,039- Expiry as listed
- 18 Feb 2027
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,501,698, product and use patent
patent.txt lines 2,994, 3,032- Expiry as listed
- 20 Jun 2027
- Rule
- R1
- Flags
- product · use code U-493
- Product numbers
- 001, 002
US 8,501,698 with pediatric exclusivity, as listed
patent.txt lines 2,993, 3,031- Expiry as listed
- 20 Dec 2027
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,221,786, product patent
patent.txt lines 2,985, 3,023- Expiry as listed
- 21 Mar 2028
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 8,361,972, use patent
patent.txt lines 2,991, 3,029- Expiry as listed
- 21 Mar 2028
- Rule
- R1
- Flags
- use code U-2139
- Product numbers
- 001, 002
US 8,361,972, use patent
patent.txt lines 2,992, 3,030- Expiry as listed
- 21 Mar 2028
- Rule
- R1
- Flags
- use code U-493
- Product numbers
- 001, 002
US 8,716,251, product patent
patent.txt lines 2,998, 3,036- Expiry as listed
- 21 Mar 2028
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 7,851,502, product patent
patent.txt lines 2,981, 3,019- Expiry as listed
- 19 Aug 2028
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002
US 8,221,786 with pediatric exclusivity, as listed
patent.txt lines 2,984, 3,022- Expiry as listed
- 21 Sep 2028
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,361,972 with pediatric exclusivity, as listed
patent.txt lines 2,990, 3,028- Expiry as listed
- 21 Sep 2028
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,716,251 with pediatric exclusivity, as listed
patent.txt lines 2,997, 3,035- Expiry as listed
- 21 Sep 2028
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 7,851,502 with pediatric exclusivity, as listed
patent.txt lines 2,980, 3,018- Expiry as listed
- 19 Feb 2029
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 7,919,598, substance patent
patent.txt lines 2,983, 3,021- Expiry as listed
- 16 Dec 2029
- Rule
- R1
- Flags
- substance
- Product numbers
- 001, 002
US 8,721,615, product patent
patent.txt lines 3,000, 3,038- Expiry as listed
- 18 Jan 2030
- Rule
- R1
- Flags
- product · delist requested
- Product numbers
- 001, 002
US 8,685,934, use patent
patent.txt lines 2,996, 3,034- Expiry as listed
- 26 May 2030
- Rule
- R1
- Flags
- use code U-1522
- Product numbers
- 001, 002
US 7,919,598 with pediatric exclusivity, as listed
patent.txt lines 2,982, 3,020- Expiry as listed
- 16 Jun 2030
- Rule
- R2
- Flags
- substance · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,721,615 with pediatric exclusivity, as listed
patent.txt lines 2,999, 3,037- Expiry as listed
- 18 Jul 2030
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 8,685,934 with pediatric exclusivity, as listed
patent.txt lines 2,995, 3,033- Expiry as listed
- 26 Nov 2030
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002
US 11,826,376, use patent
patent.txt line 3,006- Expiry as listed
- 18 Jul 2039
- Rule
- R1
- Flags
- use code U-3766
- Product numbers
- 002
US 12,472,194, use patent
patent.txt line 3,014- Expiry as listed
- 18 Jul 2039
- Rule
- R1
- Flags
- use code U-4346
- Product numbers
- 002
US 11,826,376 with pediatric exclusivity, as listed
patent.txt line 3,005- Expiry as listed
- 18 Jan 2040
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 002
US 12,472,194 with pediatric exclusivity, as listed
patent.txt line 3,013- Expiry as listed
- 18 Jan 2040
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 002
US 10,973,836, use patent
patent.txt line 3,004- Expiry as listed
- 9 Mar 2040
- Rule
- R1
- Flags
- use code U-3127
- Product numbers
- 002
US 11,903,955, use patent
patent.txt line 3,008- Expiry as listed
- 9 Mar 2040
- Rule
- R1
- Flags
- use code U-3825
- Product numbers
- 002
US 10,973,836 with pediatric exclusivity, as listed
patent.txt line 3,003- Expiry as listed
- 9 Sep 2040
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 002
US 11,903,955 with pediatric exclusivity, as listed
patent.txt line 3,007- Expiry as listed
- 9 Sep 2040
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 002
US 12,213,988, use patent
patent.txt line 3,010- Expiry as listed
- 1 Apr 2041
- Rule
- R1
- Flags
- use code U-4140
- Product numbers
- 002
US 12,409,186, use patent
patent.txt line 3,012- Expiry as listed
- 1 Apr 2041
- Rule
- R1
- Flags
- use code U-4140
- Product numbers
- 002
US 12,213,988 with pediatric exclusivity, as listed
patent.txt line 3,009- Expiry as listed
- 1 Oct 2041
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 002
US 12,409,186 with pediatric exclusivity, as listed
patent.txt line 3,011- Expiry as listed
- 1 Oct 2041
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 002
Listed exclusivities
Each exclusivity FDA lists for NDA 202293, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.
M-298 exclusivity
exclusivity.txt lines 267, 271- Date
- 8 May 2026
- Rule
- R3
- Definition
- Miscellaneous (to be checked against FDA's list)
- Product numbers
- 001, 002
PED exclusivity
exclusivity.txt lines 270, 274- Date
- 8 Nov 2026
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
NPP exclusivity
exclusivity.txt lines 268, 272- Date
- 12 Jun 2027
- Rule
- R3
- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002
PED exclusivity
exclusivity.txt lines 269, 273- Date
- 12 Dec 2027
- Rule
- R3
- Definition
- Pediatric exclusivity (to be checked against FDA's list)
- Product numbers
- 001, 002
Paragraph IV list rows giving NDA 202293
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 202293, 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 202293
Dapagliflozin · Tablets · 5 mg and 10 mg
RLD/NDA as listed: Farxiga 202293- First PIV submission
- 8 Jan 2018
- ANDAs
- 20
- 180-day status
- Eligible
- Decision posted
- 13 Apr 2026
- First applicant approval
- 6 Apr 2026
- First marketing
- 6 Apr 2026
- Last qualifying patent expiry (as listed by FDA)
- 26 May 2030
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