FDA Orange Book · active-ingredient family
Gemcitabine hydrochloride
Gemcitabine hydrochloride: 6 brands, 28 generics; first approved May 15, 1996; generic available.
Generic available1 exclusivity periodHas discontinued products
Generic status & protection
Generic available: 28 ANDA applications approved.
Earliest patent expiry Latest exclusivity ends
Brands (NDA)
6
Generics (ANDA)
28
Listed patents
7
Next patent expiry
Jun 28, 2030
in 3 yr 9 mo
Brand (NDA) products
Originator applications
- JANSSEN BIOTECHNDA 2196832025
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 225MG BASE SYSTEM INTRAVESICAL Rx - - AVYXA HOLDINGSNDA 21992020253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/5.26ML (EQ 38MG BASE/ML) SOLUTION INTRAVENOUS Discontinued - EQ 1GM BASE/26.3ML (EQ 38MG BASE/ML) SOLUTION INTRAVENOUS Rx - EQ 2GM BASE/52.6ML (EQ 38MG BASE/ML) SOLUTION INTRAVENOUS Rx - - INFUGEMRLDSUN PHARMNDA 208313201810 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1200MG BASE/120ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Discontinued - EQ 1300MG BASE/130ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Discontinued - EQ 1400MG BASE/140ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Discontinued - EQ 1500MG BASE/150ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Discontinued - EQ 1600MG BASE/160ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Discontinued - EQ 1700MG BASE/170ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Discontinued - EQ 1800MG BASE/180ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Discontinued - EQ 1900MG BASE/190ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Discontinued - EQ 2000MG BASE/200ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Discontinued - EQ 2200MG BASE/220ML (EQ 10MG BASE/ML) SOLUTION INTRAVENOUS Discontinued - - GEMCITABINE HYDROCHLORIDERLDACCORD HLTHCARENDA 20960420174 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/2ML (100MG/ML) SOLUTION INTRAVENOUS Discontinued - 1GM/10ML (100MG/ML) SOLUTION INTRAVENOUS Discontinued - 1.5GM/15ML (100MG/ML) SOLUTION INTRAVENOUS Discontinued - 2GM/20ML (100MG/ML) SOLUTION INTRAVENOUS Discontinued - - GEMCITABINE HYDROCHLORIDERLDRSHOSPIRA INCNDA 20079520113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5.26ML (38MG/ML) INJECTABLE INJECTION Rx AP 1GM/26.3ML (38MG/ML) INJECTABLE INJECTION Rx AP 2GM/52.6ML (38MG/ML) INJECTABLE INJECTION Rx AP - GEMZARRLDLILLYNDA 02050919962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued -
Generic (ANDA) products (28)
Abbreviated applications
- GEMCITABINE HYDROCHLORIDEHIKMAANDA 21317520233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5.26ML (38MG/ML) INJECTABLE INJECTION Rx AP 1GM/26.3ML (38MG/ML) INJECTABLE INJECTION Rx AP 2GM/52.6ML (38MG/ML) INJECTABLE INJECTION Rx AP - GEMCITABINE HYDROCHLORIDEHIKMA INTL PHARMSANDA 20661720212 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued - - GEMCITABINE HYDROCHLORIDEMEITHEALANDA 21212920203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5.26ML (38MG/ML) INJECTABLE INJECTION Rx AP 1GM/26.3ML (38MG/ML) INJECTABLE INJECTION Rx AP 2GM/52.6ML (38MG/ML) INJECTABLE INJECTION Rx AP - GEMCITABINE HYDROCHLORIDEADAPTISANDA 21099120193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5.26ML (38MG/ML) INJECTABLE INJECTION Rx AP 1GM/26.3ML (38MG/ML) INJECTABLE INJECTION Rx AP 2GM/52.6ML (38MG/ML) INJECTABLE INJECTION Rx AP - GEMCITABINE HYDROCHLORIDEADAPTISANDA 20757520192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - GEMCITABINE HYDROCHLORIDEINGENUS PHARMS LLCANDA 21038320193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5.26ML (38MG/ML) INJECTABLE INJECTION Discontinued - 1GM/26.3ML (38MG/ML) INJECTABLE INJECTION Discontinued - 2GM/52.6ML (38MG/ML) INJECTABLE INJECTION Discontinued - - GEMCITABINE HYDROCHLORIDESAGENT PHARMS INCANDA 20907720183 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5.26ML (38MG/ML) INJECTABLE INJECTION Rx AP 1GM/26.3ML (38MG/ML) INJECTABLE INJECTION Rx AP 2GM/52.6ML (38MG/ML) INJECTABLE INJECTION Rx AP - GEMCITABINE HYDROCHLORIDEMYLAN LABS LTDANDA 20524220173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5.26ML (38MG/ML) INJECTABLE INJECTION Rx AP 1GM/26.3ML (38MG/ML) INJECTABLE INJECTION Rx AP 2GM/52.6ML (38MG/ML) INJECTABLE INJECTION Rx AP - GEMCITABINE HYDROCHLORIDEAPOTEXANDA 20677620173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5.26ML (38MG/ML) INJECTABLE INJECTION Discontinued - 1GM/26.3ML (38MG/ML) INJECTABLE INJECTION Discontinued - 2GM/52.6ML (38MG/ML) INJECTABLE INJECTION Discontinued - - GEMCITABINE HYDROCHLORIDEACTAVIS INCANDA 20454920163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 200MG/5.26ML (38MG/ML) INJECTABLE INJECTION Discontinued - 1GM/26.3ML (38MG/ML) INJECTABLE INJECTION Discontinued - 2GM/52.6ML (38MG/ML) INJECTABLE INJECTION Discontinued - - GEMCITABINE HYDROCHLORIDEGLANDANDA 20452020162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - GEMCITABINE HYDROCHLORIDEAM REGENTANDA 20203120132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued - - GEMCITABINE HYDROCHLORIDEDR REDDYS LABS LTDANDA 2029972013
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - GEMCITABINE HYDROCHLORIDERSJIANGSU HANSOH PHARMANDA 20248520132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - GEMCITABINE HYDROCHLORIDESAGENT PHARMSANDA 09159720132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued - - GEMCITABINE HYDROCHLORIDEEMCURE PHARMS LTDANDA 20206320122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued - - GEMCITABINE HYDROCHLORIDEHAMELN RDS GMBHANDA 09066320122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued - - GEMCITABINE HYDROCHLORIDEACCORD HLTHCAREANDA 09159420113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued - - GEMCITABINE HYDROCHLORIDEACTAVIS TOTOWAANDA 07916020113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued - - GEMCITABINE HYDROCHLORIDEDR REDDYS LABS LTDANDA 09136520112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - GEMCITABINE HYDROCHLORIDEFRESENIUS KABI USAANDA 09079920113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - GEMCITABINE HYDROCHLORIDEHOSPIRAANDA 07833920112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - GEMCITABINE HYDROCHLORIDEPHARMOBEDIENTANDA 20014520113 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 2GM BASE/VIAL INJECTABLE INJECTION Discontinued - - GEMCITABINE HYDROCHLORIDESUN PHARMANDA 07843320112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - GEMCITABINE HYDROCHLORIDETEYRO LABSANDA 07875920112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 200MG BASE/VIAL INJECTABLE INJECTION Rx AP EQ 1GM BASE/VIAL INJECTABLE INJECTION Rx AP - GEMCITABINE HYDROCHLORIDEFRESENIUS KABI USAANDA 0902422011
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP - GEMCITABINE HYDROCHLORIDETEVA PHARMSANDA 07798320112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 1GM BASE/VIAL INJECTABLE INJECTION Discontinued - EQ 200MG BASE/VIAL INJECTABLE INJECTION Discontinued - - GEMCITABINE HYDROCHLORIDERSHOSPIRA INCANDA 0791832010
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 2GM BASE/VIAL INJECTABLE INJECTION Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Marketing exclusivity
Hatch-Waxman
- NPNew product exclusivity (3 years)
in 1 yr 11 mo
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 12403086 | in 3 yr 9 mo | Product | |
| 12576253 | in 4 yr 3 mo | Product | |
| 8679094 | in 5 yr 7 mo | Product | |
| 9241948 | in 6 yr 9 mo | Product | |
| 10729823 | in 7 yr 11 mo | Product | |
| 12447241 | in 7 yr 11 mo | Product | |
| 12636300 | in 12 yr 3 mo | U-4552 |
Approval history
FDA approval span
First approval
30 yr 11 mo ago
Most recent approval
1 yr 2 mo ago
Approvals span 1996–2025 across 34 FDA applications.
Brand (NDA) 618%
Generic (ANDA) 2882%
Gemcitabine hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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