Drybench Patent.
EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE, NDA 206111
The patents and exclusivities FDA's Orange Book lists for NDA 206111 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 20 Jun 2026 to 17 Nov 2034, each by its own rule; no one date stands for this product.
- Earliest listed date
- 20 Jun 2026NPP exclusivityRule R3 · Products 001, 002, 003, 004 · exclusivity.txt lines 544, 546, 548, 550
- Latest listed date
- 17 Nov 2034US 9,949,997 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 6,318, 6,349, 6,378, 6,407
- Latest substance patent
- 1 Feb 2029US 7,579,449 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 6,314, 6,345, 6,374, 6,403
- Latest listed patent
- 17 Nov 2034US 9,949,997 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 6,318, 6,349, 6,378, 6,407
- Latest exclusivity
- 20 Dec 2026PED exclusivityRule R3 · Products 001, 002, 003, 004 · exclusivity.txt lines 545, 547, 549, 551
66 use-code patents, blocking the coded use only
Products
Each product number FDA lists under NDA 206111, as listed. The sections below name products by these numbers.
Product 001 · SYNJARDY
- Dosage form; route
- TABLET;ORAL
- Strength
- 5MG;500MG
- Approval date as listed
- 26 Aug 2015
- Type as listed
- RX
- Applicant as listed
- BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Product 002 · SYNJARDY
- Dosage form; route
- TABLET;ORAL
- Strength
- 5MG;1GM
- Approval date as listed
- 26 Aug 2015
- Type as listed
- RX
- Applicant as listed
- BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Product 003 · SYNJARDY
- Dosage form; route
- TABLET;ORAL
- Strength
- 12.5MG;500MG
- Approval date as listed
- 26 Aug 2015
- Type as listed
- RX
- Applicant as listed
- BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Product 004 · SYNJARDY
- Dosage form; route
- TABLET;ORAL
- Strength
- 12.5MG;1GM
- Approval date as listed
- 26 Aug 2015
- 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.
31 entries from 120 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 6,317, 6,348, 6,377, 6,406- 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 6,316, 6,347, 6,376, 6,405- 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 6,315, 6,346, 6,375, 6,404- 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 6,314, 6,345, 6,374, 6,403- 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 6,303, 6,334, 6,363, 6,392- 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 6,302, 6,333, 6,362, 6,391- 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 10,610,489, product patent
patent.txt lines 6,293, 6,324, 6,355, 6,384- Expiry as listed
- 30 Sep 2030
- Rule
- R1
- Flags
- product
- Product numbers
- 001, 002, 003, 004
US 10,610,489 with pediatric exclusivity, as listed
patent.txt lines 6,292, 6,323, 6,354, 6,383- Expiry as listed
- 30 Mar 2031
- Rule
- R2
- Flags
- product · pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 12,527,810, use patent
patent.txt lines 6,313, 6,344, 6,373, 6,402- Expiry as listed
- 22 Apr 2033
- Rule
- R1
- Flags
- use code U-4403
- Product numbers
- 001, 002, 003, 004
US 12,527,810 with pediatric exclusivity, as listed
patent.txt lines 6,312, 6,343, 6,372, 6,401- Expiry as listed
- 22 Oct 2033
- Rule
- R2
- Flags
- pediatric, as listed by FDA (from the base row)
- Product numbers
- 001, 002, 003, 004
US 10,258,637, use patent
patent.txt lines 6,291, 6,322, 6,353, 6,382- 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 6,295, 6,326, 6,357, 6,386- 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 6,296, 6,327, 6,358, 6,387- 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 6,298, 6,329- 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 6,300, 6,331, 6,360, 6,389- 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 6,301, 6,332, 6,361, 6,390- 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 6,304, 6,335, 6,364, 6,393- 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 6,305, 6,336, 6,365, 6,394- 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 6,307, 6,338, 6,367, 6,396- 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 6,308, 6,339, 6,368, 6,397- 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 6,309, 6,340, 6,369, 6,398- 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 6,310, 6,341, 6,370, 6,399- 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 6,311, 6,342, 6,371, 6,400- 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 6,319, 6,350, 6,379, 6,408- 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 6,320, 6,351, 6,380, 6,409- Expiry as listed
- 17 May 2034
- Rule
- R1
- Flags
- use code U-3533
- Product numbers
- 001, 002, 003, 004
US 10,258,637 with pediatric exclusivity, as listed
patent.txt lines 6,290, 6,321, 6,352, 6,381- 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 6,294, 6,325, 6,356, 6,385- 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 6,297, 6,328- 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 6,299, 6,330, 6,359, 6,388- 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 6,306, 6,337, 6,366, 6,395- 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 6,318, 6,349, 6,378, 6,407- Expiry as listed
- 17 Nov 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 206111, 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 544, 546, 548, 550- Date
- 20 Jun 2026
- Rule
- R3
- Definition
- New patient population (to be checked against FDA's list)
- Product numbers
- 001, 002, 003, 004
PED exclusivity
exclusivity.txt lines 545, 547, 549, 551- 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 206111
The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 206111, 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 206111
Empagliflozin and Metformin Hydrochloride · Tablets · 5 mg/500 mg 5 mg/1000 mg 12.5 mg/500 mg 12.5 mg/1000 mg
RLD/NDA as listed: Synjardy 206111- First PIV submission
- 1 Aug 2018
- ANDAs
- 4
- 180-day status
- Eligible
- Decision posted
- 6 Sep 2022
- First applicant approval
- 7 Jul 2022
- First marketing
- blank
- Last qualifying patent expiry (as listed by FDA)
- 1 Aug 2028
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