Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
AstraZeneca
McKinsey
Merck
Dow

Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020509

See Plans and Pricing

« Back to Dashboard

NDA 020509 describes GEMZAR, which is a drug marketed by Lilly and is included in one NDA. It is available from one supplier. Additional details are available on the GEMZAR profile page.

The generic ingredient in GEMZAR is gemcitabine hydrochloride. There are thirty drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the gemcitabine hydrochloride profile page.
Summary for 020509
Tradename:GEMZAR
Applicant:Lilly
Ingredient:gemcitabine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020509
Suppliers and Packaging for NDA: 020509
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509 NDA Eli Lilly and Company 0002-7501 0002-7501-01 5 mL in 1 VIAL, SINGLE-DOSE (0002-7501-01)
GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509 NDA Eli Lilly and Company 0002-7502 0002-7502-01 25 mL in 1 VIAL, SINGLE-DOSE (0002-7502-01)
Paragraph IV (Patent) Challenges for 020509
Tradename Dosage Ingredient NDA Submissiondate
GEMZAR INJECTABLE;INJECTION gemcitabine hydrochloride 020509 2005-11-14
GEMZAR INJECTABLE;INJECTION gemcitabine hydrochloride 020509 2005-11-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/VIAL
Approval Date:May 15, 1996TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 1GM BASE/VIAL
Approval Date:May 15, 1996TE:APRLD:Yes

Expired US Patents for NDA 020509

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-002 May 15, 1996   Start Trial   Start Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996   Start Trial   Start Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-001 May 15, 1996   Start Trial   Start Trial
Lilly GEMZAR gemcitabine hydrochloride INJECTABLE;INJECTION 020509-002 May 15, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
Express Scripts
Harvard Business School
Baxter
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.