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Generated: November 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022311

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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 three 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:3
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

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength24MG/1.2ML (20MG/ML)
Approval Date:Dec 15, 2008TE:RLD:Yes
Patent:➤ Sign UpPatent 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:➤ Sign UpPatent 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:➤ Sign UpPatent Expiration:Dec 10, 2018Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022311

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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