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Last Updated: June 28, 2022

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-two 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.

Summary for plerixafor
Recent Clinical Trials for plerixafor

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

SponsorPhase
4Living BiotechPhase 2
National Heart, Lung, and Blood Institute (NHLBI)Phase 1/Phase 2
Hugh TaylorEarly Phase 1

See all plerixafor clinical trials

Generic filers with tentative approvals for PLERIXAFOR
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing24MG/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 Strength NDA ANDAs Submitted Submissiondate
MOZOBIL Injection plerixafor 24 mg/1.2 mL vials (20 mg/mL) 022311 3 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for plerixafor

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 See Plans and Pricing See Plans and Pricing
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for plerixafor

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Genzyme Europe BV Mozobil plerixafor EMEA/H/C/001030
Mozobil is indicated in combination with granulocyte-colony-stimulating factor to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma whose cells mobilise poorly.
Authorised no no no 2009-07-30
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for plerixafor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2371361 PA2019018 Lithuania See Plans and Pricing PRODUCT NAME: PLERIKSAFORAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, ARBA METALO KOMPLEKSAS; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
2371361 301031 Netherlands See Plans and Pricing PRODUCT NAME: PLERIXAFOR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX DAARVAN; REGISTRATION NO/DATE: EU/1/09/537/001 20090804
2371361 CA 2019 00044 Denmark See Plans and Pricing 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
0619813 C300425 Netherlands See Plans and Pricing PRODUCT NAME: PLERIXAFOR, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH ZUURADDITIE ZOUT OF METAALCOMPLEX; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
1411918 2012C/027 Belgium See Plans and Pricing PRODUCT NAME: PLERIXAFOR SOUS TOUTES FORMES COUVERTES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/09/537/001 20090804
1411918 PA2012011 Lithuania See Plans and Pricing PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
2371361 CR 2019 00044 Denmark See Plans and Pricing PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REG. NO/DATE: EU/1/09/537/001 20090731
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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