Drybench Patent.

METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE, NDA 202270

The patents and exclusivities FDA's Orange Book lists for NDA 202270 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 24 Nov 2026 to 24 May 2027, each by its own rule; no one date stands for this product.

Earliest listed date: 24 Nov 2026US 7,326,708, substance and product and use patentRule R1 · Products 001, 002, 003 · patent.txt lines 2,961, 2,963, 2,965
Latest listed date: 24 May 2027US 7,326,708 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 2,960, 2,962, 2,964
Latest substance patent: 24 May 2027US 7,326,708 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 2,960, 2,962, 2,964
Latest listed patent: 24 May 2027US 7,326,708 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 2,960, 2,962, 2,964
Latest exclusivity: None listed

3 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 202270, as listed. The sections below name products by these numbers.

Product 001 · JANUMET XR
Dosage form; route
TABLET, EXTENDED RELEASE;ORAL
Strength
500MG;EQ 50MG BASE
Approval date as listed
2 Feb 2012
Type as listed
RX
Applicant as listed
MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
Product 002 · JANUMET XR
Dosage form; route
TABLET, EXTENDED RELEASE;ORAL
Strength
1GM;EQ 50MG BASE
Approval date as listed
2 Feb 2012
Type as listed
RX
Applicant as listed
MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC
Product 003 · JANUMET XR
Dosage form; route
TABLET, EXTENDED RELEASE;ORAL
Strength
1GM;EQ 100MG BASE
Approval date as listed
2 Feb 2012
Type as listed
RX
Applicant as listed
MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO 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.

2 entries from 6 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 7,326,708, substance and product and use patent
patent.txt lines 2,961, 2,963, 2,965
Expiry as listed
24 Nov 2026
Rule
R1
Flags
substance · product · use code U-1227
Product numbers
001, 002, 003
US 7,326,708 with pediatric exclusivity, as listed
patent.txt lines 2,960, 2,962, 2,964
Expiry as listed
24 May 2027
Rule
R2
Flags
substance · product · pediatric, as listed by FDA (from the base row)
Product numbers
001, 002, 003

Listed exclusivities

Each exclusivity FDA lists for NDA 202270, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

The Orange Book capture of 14 October 2026 lists no exclusivity for NDA 202270.

Paragraph IV list rows giving NDA 202270

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 202270, 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 202270

Sitagliptin Phosphate and Metformin Hydrochloride · Extended-release Tablets · 100 mg/1000 mg
RLD/NDA as listed: Janumet XR 202270
First PIV submission
22 Oct 2012
ANDAs
1
180-day status
Eligible
Decision posted
9 Jun 2025
First applicant approval
4 Jun 2025
First marketing
blank
Last qualifying patent expiry (as listed by FDA)
24 Nov 2026
Sitagliptin Phosphate and Metformin Hydrochloride · Extended-release Tablets · 50 mg/500 mg and 50 mg/1000 mg
RLD/NDA as listed: Janumet XR 202270
First PIV submission
16 Mar 2012
ANDAs
1
180-day status
Eligible
Decision posted
9 Jun 2025
First applicant approval
4 Jun 2025
First marketing
blank
Last qualifying patent expiry (as listed by FDA)
24 Nov 2026

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