Drybench Patent.

CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE, NDA 205879

The patents and exclusivities FDA's Orange Book lists for NDA 205879 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.

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Listed protection

Listed dates run from 14 Jul 2027 to 26 Aug 2029, each by its own rule; no one date stands for this product.

Earliest listed date: 14 Jul 2027US 7,943,788, substance and product patentRule R1 · Products 001, 002, 003, 004 · patent.txt lines 6,004, 6,014, 6,024, 6,034
Latest listed date: 26 Aug 2029US 7,943,582 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 5,999, 6,009, 6,019, 6,029
Latest substance patent: 26 Aug 2029US 7,943,582 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 5,999, 6,009, 6,019, 6,029
Latest listed patent: 26 Aug 2029US 7,943,582 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 5,999, 6,009, 6,019, 6,029
Latest exclusivity: 18 Jun 2028PED exclusivityRule R3 · Products 001, 002, 003, 004 · exclusivity.txt lines 537, 539, 541, 543

24 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 205879, as listed. The sections below name products by these numbers.

Product 001 · INVOKAMET XR
Dosage form; route
TABLET, EXTENDED RELEASE;ORAL
Strength
50MG;500MG
Approval date as listed
20 Sep 2016
Type as listed
RX
Applicant as listed
JANSSEN PHARMACEUTICALS INC
Product 002 · INVOKAMET XR
Dosage form; route
TABLET, EXTENDED RELEASE;ORAL
Strength
50MG;1GM
Approval date as listed
20 Sep 2016
Type as listed
RX
Applicant as listed
JANSSEN PHARMACEUTICALS INC
Product 003 · INVOKAMET XR
Dosage form; route
TABLET, EXTENDED RELEASE;ORAL
Strength
150MG;500MG
Approval date as listed
20 Sep 2016
Type as listed
RX
Applicant as listed
JANSSEN PHARMACEUTICALS INC
Product 004 · INVOKAMET XR
Dosage form; route
TABLET, EXTENDED RELEASE;ORAL
Strength
150MG;1GM
Approval date as listed
20 Sep 2016
Type as listed
RX
Applicant as listed
JANSSEN 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.

10 entries from 40 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 7,943,788, substance and product patent
patent.txt lines 6,004, 6,014, 6,024, 6,034
Expiry as listed
14 Jul 2027
Rule
R1
Flags
substance · product
Product numbers
001, 002, 003, 004
US 8,513,202, substance and product and use patent
patent.txt lines 6,006, 6,016, 6,026, 6,036
Expiry as listed
3 Dec 2027
Rule
R1
Flags
substance · product · use code U-2441
Product numbers
001, 002, 003, 004
US 8,513,202, substance and product and use patent
patent.txt lines 6,007, 6,017, 6,027, 6,037
Expiry as listed
3 Dec 2027
Rule
R1
Flags
substance · product · use code U-2632
Product numbers
001, 002, 003, 004
US 8,513,202, substance and product and use patent
patent.txt lines 6,008, 6,018, 6,028, 6,038
Expiry as listed
3 Dec 2027
Rule
R1
Flags
substance · product · use code U-493
Product numbers
001, 002, 003, 004
US 7,943,788 with pediatric exclusivity, as listed
patent.txt lines 6,003, 6,013, 6,023, 6,033
Expiry as listed
14 Jan 2028
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
US 8,513,202 with pediatric exclusivity, as listed
patent.txt lines 6,005, 6,015, 6,025, 6,035
Expiry as listed
3 Jun 2028
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004
US 7,943,582, substance and product and use patent
patent.txt lines 6,000, 6,010, 6,020, 6,030
Expiry as listed
26 Feb 2029
Rule
R1
Flags
substance · product · use code U-2441
Product numbers
001, 002, 003, 004
US 7,943,582, substance and product and use patent
patent.txt lines 6,001, 6,011, 6,021, 6,031
Expiry as listed
26 Feb 2029
Rule
R1
Flags
substance · product · use code U-2632
Product numbers
001, 002, 003, 004
US 7,943,582, substance and product and use patent
patent.txt lines 6,002, 6,012, 6,022, 6,032
Expiry as listed
26 Feb 2029
Rule
R1
Flags
substance · product · use code U-493
Product numbers
001, 002, 003, 004
US 7,943,582 with pediatric exclusivity, as listed
patent.txt lines 5,999, 6,009, 6,019, 6,029
Expiry as listed
26 Aug 2029
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003, 004

Listed exclusivities

Each exclusivity FDA lists for NDA 205879, 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 lines 536, 538, 540, 542
Date
18 Dec 2027
Rule
R3
Definition
New patient population (to be checked against FDA's list)
Product numbers
001, 002, 003, 004
PED exclusivity
exclusivity.txt lines 537, 539, 541, 543
Date
18 Jun 2028
Rule
R3
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004

Paragraph IV list rows giving NDA 205879

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 205879, 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 205879

Canagliflozin and Metformin Hydrochloride · Extended-release Tablets · 50 mg/500 mg 50 mg/1000 mg 150 mg/500 mg 150 mg/1000 mg
RLD/NDA as listed: Invokamet-XR 205879
First PIV submission
21 Nov 2018
ANDAs
1
180-day status
blank
Decision posted
blank
First applicant approval
blank
First marketing
blank
Last qualifying patent expiry (as listed by FDA)
26 Feb 2029

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