Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
Colorcon
Baxter
Johnson and Johnson
Express Scripts

Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022311

See Plans and Pricing

« Back to Dashboard

NDA 022311 describes MOZOBIL, which is a drug marketed by Genzyme and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the MOZOBIL profile page.

The generic ingredient in MOZOBIL is plerixafor. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the plerixafor profile page.
Summary for 022311
Tradename:MOZOBIL
Applicant:Genzyme
Ingredient:plerixafor
Patents:2
Generic Entry Opportunity Date for 022311
Generic Entry Date for 022311*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 022311
Suppliers and Packaging for NDA: 022311
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311 NDA sanofi-aventis U.S. LLC 0024-5862 0024-5862-01 1 VIAL, SINGLE-USE in 1 CARTON (0024-5862-01) > 1.2 mL in 1 VIAL, SINGLE-USE
Paragraph IV (Patent) Challenges for 022311
Tradename Dosage Ingredient NDA Submissiondate
MOZOBIL SOLUTION;SUBCUTANEOUS plerixafor 022311 2012-12-17

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength24MG/1.2ML (20MG/ML)
Approval Date:Dec 15, 2008TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jul 22, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:USE IN COMBINATION WITH GRANULOCYTE-COLONY STIMULATING FACTOR (G-CSF) TO MOBILIZE HEMATOPOIETIC STEM CELLS TO PERIPHERAL BLOOD FOR COLLECTION & SUBSEQUENT AUTOLOGOUS TRANSPLANTATION IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA & MULTIPLE MYELOMA
Patent:  Start TrialPatent Expiration:Jul 22, 2023Product Flag?Substance Flag?Delist Request?
Patented Use:USE IN COMBINATION WITH GRANULOCYTE-COLONY STIMULATING FACTOR (G-CSF) TO MOBILIZE HEMATOPOIETIC STEM CELLS TO PERIPHERAL BLOOD FOR COLLECTION & SUBSEQUENT AUTOLOGOUS TRANSPLANTATION IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA & MULTIPLE MYELOMA

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
AstraZeneca
Medtronic
McKesson
Boehringer Ingelheim

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.