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EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE, NDA 208658

The patents and exclusivities FDA's Orange Book lists for NDA 208658 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 20 Jun 2026 to 11 Dec 2034, each by its own rule; no one date stands for this product.

Earliest listed date
20 Jun 2026M-296 exclusivityRule R3 · Products 001, 002, 003, 004 · exclusivity.txt lines 725, 727, 729, 731
Latest listed date
11 Dec 2034US 9,949,998 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 9,066, 9,098, 9,128, 9,158
Latest substance patent
1 Feb 2029US 7,579,449 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 9,059, 9,091, 9,121, 9,151
Latest listed patent
11 Dec 2034US 9,949,998 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 9,066, 9,098, 9,128, 9,158
Latest exclusivity
20 Dec 2026PED exclusivityRule R3 · Products 001, 002, 003, 004 · exclusivity.txt lines 726, 728, 730, 732

74 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 208658, as listed. The sections below name products by these numbers.

  • Product 001 · SYNJARDY XR

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    5MG;1GM
    Approval date as listed
    9 Dec 2016
    Type as listed
    RX
    Applicant as listed
    BOEHRINGER INGELHEIM PHARMACEUTICALS INC

  • Product 002 · SYNJARDY XR

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    10MG;1GM
    Approval date as listed
    9 Dec 2016
    Type as listed
    RX
    Applicant as listed
    BOEHRINGER INGELHEIM PHARMACEUTICALS INC

  • Product 003 · SYNJARDY XR

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    12.5MG;1GM
    Approval date as listed
    9 Dec 2016
    Type as listed
    RX
    Applicant as listed
    BOEHRINGER INGELHEIM PHARMACEUTICALS INC

  • Product 004 · SYNJARDY XR

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    25MG;1GM
    Approval date as listed
    9 Dec 2016
    Type as listed
    RX
    Applicant as listed
    BOEHRINGER INGELHEIM 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.

32 entries from 124 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 7,713,938, substance and product patent

    patent.txt lines 9,062, 9,094, 9,124, 9,154
    Expiry as listed
    15 Apr 2027
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004

  • US 7,713,938 with pediatric exclusivity, as listed

    patent.txt lines 9,061, 9,093, 9,123, 9,153
    Expiry as listed
    15 Oct 2027
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 7,579,449, substance patent

    patent.txt lines 9,060, 9,092, 9,122, 9,152
    Expiry as listed
    1 Aug 2028
    Rule
    R1
    Flags
    substance
    Product numbers
    001, 002, 003, 004

  • US 7,579,449 with pediatric exclusivity, as listed

    patent.txt lines 9,059, 9,091, 9,121, 9,151
    Expiry as listed
    1 Feb 2029
    Rule
    R2
    Flags
    substance · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 12,115,179, use patent

    patent.txt lines 9,050, 9,082, 9,112, 9,142
    Expiry as listed
    11 Feb 2030
    Rule
    R1
    Flags
    use code U-4023
    Product numbers
    001, 002, 003, 004

  • US 12,115,179 with pediatric exclusivity, as listed

    patent.txt lines 9,049, 9,081, 9,111, 9,141
    Expiry as listed
    11 Aug 2030
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 10,596,120, product and use patent

    patent.txt lines 9,039, 9,071, 9,103, 9,133
    Expiry as listed
    7 Mar 2032
    Rule
    R1
    Flags
    product · use code U-2775
    Product numbers
    001, 002, 003, 004

  • US 10,596,120, product and use patent

    patent.txt lines 9,040, 9,072, 9,104, 9,134
    Expiry as listed
    7 Mar 2032
    Rule
    R1
    Flags
    product · use code U-2792
    Product numbers
    001, 002, 003, 004

  • US 10,596,120 with pediatric exclusivity, as listed

    patent.txt lines 9,038, 9,070, 9,102, 9,132
    Expiry as listed
    7 Sep 2032
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 10,258,637, use patent

    patent.txt lines 9,037, 9,069, 9,101, 9,131
    Expiry as listed
    3 Apr 2034
    Rule
    R1
    Flags
    use code U-2290
    Product numbers
    001, 002, 003, 004

  • US 11,090,323, use patent

    patent.txt lines 9,042, 9,074, 9,106, 9,136
    Expiry as listed
    3 Apr 2034
    Rule
    R1
    Flags
    use code U-3193
    Product numbers
    001, 002, 003, 004

  • US 11,666,590, use patent

    patent.txt lines 9,043, 9,075, 9,107, 9,137
    Expiry as listed
    3 Apr 2034
    Rule
    R1
    Flags
    use code U-4154
    Product numbers
    001, 002, 003, 004

  • US 11,813,275, use patent

    patent.txt lines 9,045, 9,077
    Expiry as listed
    3 Apr 2034
    Rule
    R1
    Flags
    use code U-3759
    Product numbers
    001, 002

  • US 11,833,166, use patent

    patent.txt lines 9,047, 9,079, 9,109, 9,139
    Expiry as listed
    3 Apr 2034
    Rule
    R1
    Flags
    use code U-3776
    Product numbers
    001, 002, 003, 004

  • US 11,833,166, use patent

    patent.txt lines 9,048, 9,080, 9,110, 9,140
    Expiry as listed
    3 Apr 2034
    Rule
    R1
    Flags
    use code U-3777
    Product numbers
    001, 002, 003, 004

  • US 12,263,153, use patent

    patent.txt lines 9,051, 9,083, 9,113, 9,143
    Expiry as listed
    3 Apr 2034
    Rule
    R1
    Flags
    use code U-4154
    Product numbers
    001, 002, 003, 004

  • US 12,427,162, use patent

    patent.txt lines 9,052, 9,084, 9,114, 9,144
    Expiry as listed
    3 Apr 2034
    Rule
    R1
    Flags
    use code U-4287
    Product numbers
    001, 002, 003, 004

  • US 12,433,906, use patent

    patent.txt lines 9,054, 9,086, 9,116, 9,146
    Expiry as listed
    3 Apr 2034
    Rule
    R1
    Flags
    use code U-4293
    Product numbers
    001, 002, 003, 004

  • US 12,433,906, use patent

    patent.txt lines 9,055, 9,087, 9,117, 9,147
    Expiry as listed
    3 Apr 2034
    Rule
    R1
    Flags
    use code U-4294
    Product numbers
    001, 002, 003, 004

  • US 12,433,906, use patent

    patent.txt lines 9,056, 9,088, 9,118, 9,148
    Expiry as listed
    3 Apr 2034
    Rule
    R1
    Flags
    use code U-4295
    Product numbers
    001, 002, 003, 004

  • US 12,433,906, use patent

    patent.txt lines 9,057, 9,089, 9,119, 9,149
    Expiry as listed
    3 Apr 2034
    Rule
    R1
    Flags
    use code U-4296
    Product numbers
    001, 002, 003, 004

  • US 12,433,906, use patent

    patent.txt lines 9,058, 9,090, 9,120, 9,150
    Expiry as listed
    3 Apr 2034
    Rule
    R1
    Flags
    use code U-4304
    Product numbers
    001, 002, 003, 004

  • US 9,949,997, use patent

    patent.txt lines 9,064, 9,096, 9,126, 9,156
    Expiry as listed
    17 May 2034
    Rule
    R1
    Flags
    use code U-3532
    Product numbers
    001, 002, 003, 004

  • US 9,949,997, use patent

    patent.txt lines 9,065, 9,097, 9,127, 9,157
    Expiry as listed
    17 May 2034
    Rule
    R1
    Flags
    use code U-3533
    Product numbers
    001, 002, 003, 004

  • US 9,949,998, use patent

    patent.txt lines 9,067, 9,099, 9,129, 9,159
    Expiry as listed
    11 Jun 2034
    Rule
    R1
    Flags
    use code U-2290
    Product numbers
    001, 002, 003, 004

  • US 10,258,637 with pediatric exclusivity, as listed

    patent.txt lines 9,036, 9,068, 9,100, 9,130
    Expiry as listed
    3 Oct 2034
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 11,090,323 with pediatric exclusivity, as listed

    patent.txt lines 9,041, 9,073, 9,105, 9,135
    Expiry as listed
    3 Oct 2034
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 11,813,275 with pediatric exclusivity, as listed

    patent.txt lines 9,044, 9,076
    Expiry as listed
    3 Oct 2034
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002

  • US 11,833,166 with pediatric exclusivity, as listed

    patent.txt lines 9,046, 9,078, 9,108, 9,138
    Expiry as listed
    3 Oct 2034
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 12,433,906 with pediatric exclusivity, as listed

    patent.txt lines 9,053, 9,085, 9,115, 9,145
    Expiry as listed
    3 Oct 2034
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 9,949,997 with pediatric exclusivity, as listed

    patent.txt lines 9,063, 9,095, 9,125, 9,155
    Expiry as listed
    17 Nov 2034
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 9,949,998 with pediatric exclusivity, as listed

    patent.txt lines 9,066, 9,098, 9,128, 9,158
    Expiry as listed
    11 Dec 2034
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

Listed exclusivities

Each exclusivity FDA lists for NDA 208658, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

  • M-296 exclusivity

    exclusivity.txt lines 725, 727, 729, 731
    Date
    20 Jun 2026
    Rule
    R3
    Definition
    Miscellaneous (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004

  • PED exclusivity

    exclusivity.txt lines 726, 728, 730, 732
    Date
    20 Dec 2026
    Rule
    R3
    Definition
    Pediatric exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004

Paragraph IV list rows giving NDA 208658

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 208658, 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 208658

  • Empagliflozin and Metformin Hydrochloride · Extended-release Tablets · 5 mg/1000 mg 10 mg/1000 mg 12.5 mg/1000 mg 25 mg/1000 mg

    RLD/NDA as listed: Synjardy XR 208658
    First PIV submission
    1 Aug 2018
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    11 Jun 2034

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