Drybench Patent.

LINAGLIPTIN; METFORMIN HYDROCHLORIDE, NDA 201281

The patents and exclusivities FDA's Orange Book lists for NDA 201281 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 26 Nov 2025 to 8 Dec 2037, each by its own rule; no one date stands for this product.

Earliest listed date: 26 Nov 2025US 8,883,805, product patentRule R1 · Products 001, 002, 003 · patent.txt lines 2,357, 2,375, 2,393
Latest listed date: 8 Dec 2037US 12,364,700 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 2,349, 2,367, 2,385
Latest substance patent: None listed
Latest listed patent: 8 Dec 2037US 12,364,700 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 2,349, 2,367, 2,385
Latest exclusivity: 20 Dec 2026PED exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 218, 220, 222

4 patents with a delist request, kept in the table · 15 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 201281, as listed. The sections below name products by these numbers.

Product 001 · JENTADUETO
Dosage form; route
TABLET;ORAL
Strength
2.5MG;500MG
Approval date as listed
30 Jan 2012
Type as listed
RX
Applicant as listed
BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Product 002 · JENTADUETO
Dosage form; route
TABLET;ORAL
Strength
2.5MG;850MG
Approval date as listed
30 Jan 2012
Type as listed
RX
Applicant as listed
BOEHRINGER INGELHEIM PHARMACEUTICALS INC
Product 003 · JENTADUETO
Dosage form; route
TABLET;ORAL
Strength
2.5MG;1GM
Approval date as listed
30 Jan 2012
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.

19 entries from 54 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 8,883,805, product patent
patent.txt lines 2,357, 2,375, 2,393
Expiry as listed
26 Nov 2025
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 8,883,805 with pediatric exclusivity, as listed
patent.txt lines 2,356, 2,374, 2,392
Expiry as listed
26 May 2026
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
US 8,673,927, use patent
patent.txt lines 2,353, 2,371, 2,389
Expiry as listed
4 May 2027
Rule
R1
Flags
use code U-1503 · delist requested
Product numbers
001, 002, 003
US 8,673,927 with pediatric exclusivity, as listed
patent.txt lines 2,352, 2,370, 2,388
Expiry as listed
4 Nov 2027
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
US 10,022,379, use patent
patent.txt lines 2,345, 2,363, 2,381
Expiry as listed
2 Apr 2029
Rule
R1
Flags
use code U-2339
Product numbers
001, 002, 003
US 10,973,827, product patent
patent.txt lines 2,347, 2,365, 2,383
Expiry as listed
2 Apr 2029
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 12,678,442, product patent
patent.txt lines 2,351, 2,369, 2,387
Expiry as listed
2 Apr 2029
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 9,415,016, product patent
patent.txt lines 2,361, 2,379, 2,397
Expiry as listed
2 Apr 2029
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 10,022,379 with pediatric exclusivity, as listed
patent.txt lines 2,344, 2,362, 2,380
Expiry as listed
2 Oct 2029
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
US 10,973,827 with pediatric exclusivity, as listed
patent.txt lines 2,346, 2,364, 2,382
Expiry as listed
2 Oct 2029
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
US 9,415,016 with pediatric exclusivity, as listed
patent.txt lines 2,360, 2,378, 2,396
Expiry as listed
2 Oct 2029
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
US 11,911,388, use patent
patent.txt lines 2,348, 2,366, 2,384
Expiry as listed
10 Apr 2030
Rule
R1
Flags
use code U-3854
Product numbers
001, 002, 003
US 9,155,705, product patent
patent.txt lines 2,359, 2,377, 2,395
Expiry as listed
21 May 2030
Rule
R1
Flags
product
Product numbers
001, 002, 003
US 8,846,695, use patent
patent.txt lines 2,355, 2,373
Expiry as listed
4 Jun 2030
Rule
R1
Flags
use code U-1503
Product numbers
001, 002
US 8,846,695, use patent
patent.txt line 2,391
Expiry as listed
4 Jun 2030
Rule
R1
Flags
use code U-1503 · delist requested
Product numbers
003
US 9,155,705 with pediatric exclusivity, as listed
patent.txt lines 2,358, 2,376, 2,394
Expiry as listed
21 Nov 2030
Rule
R2
Flags
product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
US 8,846,695 with pediatric exclusivity, as listed
patent.txt lines 2,354, 2,372, 2,390
Expiry as listed
4 Dec 2030
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003
US 12,364,700, use patent
patent.txt lines 2,350, 2,368, 2,386
Expiry as listed
8 Jun 2037
Rule
R1
Flags
use code U-4224
Product numbers
001, 002, 003
US 12,364,700 with pediatric exclusivity, as listed
patent.txt lines 2,349, 2,367, 2,385
Expiry as listed
8 Dec 2037
Rule
R2
Flags
pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003

Listed exclusivities

Each exclusivity FDA lists for NDA 201281, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

M-295 exclusivity
exclusivity.txt lines 217, 219, 221
Date
20 Jun 2026
Rule
R3
Definition
Miscellaneous (to be checked against FDA's list)
Product numbers
001, 002, 003
PED exclusivity
exclusivity.txt lines 218, 220, 222
Date
20 Dec 2026
Rule
R3
Definition
Pediatric exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003

Paragraph IV list rows giving NDA 201281

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 201281, 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 201281

Linagliptin and Metformin Hydrochloride · Tablets · 2.5 mg/500 mg 2.5 mg/850 mg 2.5 mg/1000 mg
RLD/NDA as listed: Jentadueto 201281
First PIV submission
4 May 2015
ANDAs
8
180-day status
Eligible
Decision posted
7 Sep 2021
First applicant approval
30 Aug 2021
First marketing
blank
Last qualifying patent expiry (as listed by FDA)
4 Jun 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 exclusivity How to read the Orange Book data files Paragraph IV certification What changed, by week