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Last Updated: December 5, 2020

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Plerixafor - Generic Drug Details

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What are the generic drug sources for plerixafor and what is the scope of freedom to operate?

Plerixafor is the generic ingredient in one branded drug marketed by Genzyme and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Plerixafor has fifty-one patent family members in twenty-seven countries.

There are seven drug master file entries for plerixafor. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for plerixafor

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
National Institutes of Health (NIH)Phase 2
General Oncology, Inc.Phase 2
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsPhase 2

See all plerixafor clinical trials

Generic filers with tentative approvals for PLERIXAFOR
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial24MG/2.1MLSOLUTION; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for plerixafor
Paragraph IV (Patent) Challenges for PLERIXAFOR
Tradename Dosage Ingredient NDA Submissiondate
MOZOBIL SOLUTION;SUBCUTANEOUS plerixafor 022311 2012-12-17

US Patents and Regulatory Information for plerixafor

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for plerixafor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2371361 CA 2019 00044 Denmark   Start Trial PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REG. NO/DATE: EU/1/09/527/001 20090731
1411918 2012C/027 Belgium   Start Trial PRODUCT NAME: PLERIXAFOR SOUS TOUTES FORMES COUVERTES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/09/537/001 20090804
1411918 132012902063874 Italy   Start Trial PRODUCT NAME: PLERIXAFOR(MOZOBIL); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/09/537/001, 20090731
2371361 19C1058 France   Start Trial PRODUCT NAME: PLERIXAFOR OU SEL OU COMPLEXE METALLIQUE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/09/537/001 20090804; FIRST REGISTRATION: NL - EU/1/09/537/001 20090804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Medtronic

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