Drybench Patent.

GEMCITABINE HYDROCHLORIDE, NDA 208313

The patents and exclusivities FDA's Orange Book lists for NDA 208313 as captured on 14 October 2026, each date named by its rule and its rows, and any rows of FDA's Paragraph IV list captured on 17 October 2026 that give this NDA's number. 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.

Open in the app GEMCITABINE HYDROCHLORIDE in the molecule app

Listed protection

Listed dates run from 1 Jul 2033 to 1 Jul 2033, each by its own rule; no one date stands for this product.

Earliest listed date: 1 Jul 2033US 9,241,948, product patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007, 008, 009, 010
Source lines
patent.txt lines 8,449–8,458
Latest listed date: 1 Jul 2033US 9,241,948, product patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007, 008, 009, 010
Source lines
patent.txt lines 8,449–8,458
Latest substance patent: None listed
Latest listed patent: 1 Jul 2033US 9,241,948, product patentRule R1 · Products 001, 002, 003, 004, 005, 006, 007, 008, 009, 010
Source lines
patent.txt lines 8,449–8,458
Latest exclusivity: None listed

Listed dates of other NDAs in the same years:2033

Products

Each product number FDA lists under NDA 208313, as listed. The sections below name products by these numbers.

Product 001 · INFUGEM
Dosage form; route
SOLUTION;INTRAVENOUS
Strength
EQ 1200MG BASE/120ML (EQ 10MG BASE/ML)
Approval date as listed
16 Jul 2018
Type as listed
DISCN
Applicant as listed
SUN PHARMACEUTICAL INDUSTRIES LTD
Product 002 · INFUGEM
Dosage form; route
SOLUTION;INTRAVENOUS
Strength
EQ 1300MG BASE/130ML (EQ 10MG BASE/ML)
Approval date as listed
16 Jul 2018
Type as listed
DISCN
Applicant as listed
SUN PHARMACEUTICAL INDUSTRIES LTD
Product 003 · INFUGEM
Dosage form; route
SOLUTION;INTRAVENOUS
Strength
EQ 1400MG BASE/140ML (EQ 10MG BASE/ML)
Approval date as listed
16 Jul 2018
Type as listed
DISCN
Applicant as listed
SUN PHARMACEUTICAL INDUSTRIES LTD
Product 004 · INFUGEM
Dosage form; route
SOLUTION;INTRAVENOUS
Strength
EQ 1500MG BASE/150ML (EQ 10MG BASE/ML)
Approval date as listed
16 Jul 2018
Type as listed
DISCN
Applicant as listed
SUN PHARMACEUTICAL INDUSTRIES LTD
Product 005 · INFUGEM
Dosage form; route
SOLUTION;INTRAVENOUS
Strength
EQ 1600MG BASE/160ML (EQ 10MG BASE/ML)
Approval date as listed
16 Jul 2018
Type as listed
DISCN
Applicant as listed
SUN PHARMACEUTICAL INDUSTRIES LTD
Product 006 · INFUGEM
Dosage form; route
SOLUTION;INTRAVENOUS
Strength
EQ 1700MG BASE/170ML (EQ 10MG BASE/ML)
Approval date as listed
16 Jul 2018
Type as listed
DISCN
Applicant as listed
SUN PHARMACEUTICAL INDUSTRIES LTD
Product 007 · INFUGEM
Dosage form; route
SOLUTION;INTRAVENOUS
Strength
EQ 1800MG BASE/180ML (EQ 10MG BASE/ML)
Approval date as listed
16 Jul 2018
Type as listed
DISCN
Applicant as listed
SUN PHARMACEUTICAL INDUSTRIES LTD
Product 008 · INFUGEM
Dosage form; route
SOLUTION;INTRAVENOUS
Strength
EQ 1900MG BASE/190ML (EQ 10MG BASE/ML)
Approval date as listed
16 Jul 2018
Type as listed
DISCN
Applicant as listed
SUN PHARMACEUTICAL INDUSTRIES LTD
Product 009 · INFUGEM
Dosage form; route
SOLUTION;INTRAVENOUS
Strength
EQ 2000MG BASE/200ML (EQ 10MG BASE/ML)
Approval date as listed
16 Jul 2018
Type as listed
DISCN
Applicant as listed
SUN PHARMACEUTICAL INDUSTRIES LTD
Product 010 · INFUGEM
Dosage form; route
SOLUTION;INTRAVENOUS
Strength
EQ 2200MG BASE/220ML (EQ 10MG BASE/ML)
Approval date as listed
16 Jul 2018
Type as listed
DISCN
Applicant as listed
SUN PHARMACEUTICAL INDUSTRIES LTD

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.

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

US 9,241,948, product patent
patent.txt lines 8,449–8,458
Expiry as listed
1 Jul 2033
Rule
R1
Flags
product
Product numbers
001, 002, 003, 004, 005, 006, 007, 008, 009, 010

Listed exclusivities

Each exclusivity FDA lists for NDA 208313, 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 208313.

Paragraph IV list rows giving NDA 208313

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 208313, each cell as listed.

Rows with no NDA number this page can match are kept apart on the list page; some may concern this product.

No row of the Paragraph IV list captured on 17 October 2026 gives NDA 208313 in its RLD/NDA cell. This does not mean no certification was submitted or that no application challenges a patent listed here.

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