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Last Updated: November 28, 2023

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 two branded drugs marketed by Genzyme, Amneal, Dr Reddys, Eugia Pharma, Kindos, MSN, Teva Pharms Usa Inc, and Zydus Pharms, and is included in eight NDAs. 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. Ten suppliers are listed for this compound.

Summary for plerixafor
Recent Clinical Trials for plerixafor

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

SponsorPhase
Rehab WeridaN/A
Peking UniversityPhase 4
bluebird bioPhase 2

See all plerixafor clinical trials

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
Dr Reddys PLERIXAFOR plerixafor SOLUTION;SUBCUTANEOUS 205182-001 Jul 24, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa Inc PLERIXAFOR plerixafor SOLUTION;SUBCUTANEOUS 205197-001 Jul 24, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal PLERIXAFOR plerixafor SOLUTION;SUBCUTANEOUS 215334-001 Jul 24, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms PLERIXAFOR plerixafor SOLUTION;SUBCUTANEOUS 208980-001 Jul 26, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msn PLERIXAFOR plerixafor SOLUTION;SUBCUTANEOUS 211901-001 Jul 24, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma PLERIXAFOR plerixafor SOLUTION;SUBCUTANEOUS 213672-001 Jul 24, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 ⤷  Try a Trial ⤷  Try a Trial
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 ⤷  Try a Trial ⤷  Try a Trial
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 ⤷  Try a Trial ⤷  Try a Trial
>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
Sanofi B.V. 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
Accord Healthcare S.L.U. Plerixafor Accord plerixafor EMEA/H/C/005943
Adult patientsPlerixafor Accord is indicated in combination with granulocyte-colony stimulating factor (G-CSF) to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in adult patients with lymphoma or multiple myeloma whose cells mobilise poorly (see section 4.2).Paediatric patients (1 to less than 18 years)Plerixafor Accord is indicated in combination with G-CSF to enhance mobilisation of haematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in children with lymphoma or solid malignant tumours, either:- pre-emptively, when circulating stem cell count on the predicted day of collection after adequate mobilization with G-CSF (with or without chemotherapy) is expected to be insufficient with regards to desired hematopoietic stem cells yield, or- who previously failed to collect sufficient haematopoietic stem cells (see section 4.2).
Authorised yes no no 2022-12-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for plerixafor

Country Patent Number Title Estimated Expiration
Japan 2006526646 ⤷  Try a Trial
Brazil PI0211570 uso de 1'-[1,4-fenileno-bis-(metileno)-bis-1,4,8,11- tetrazaciclotetradecano ou um sal farmaceuticamente aceitável do mesmo na preparação de uma composição para coletar células progenitoras e/ou tronco ⤷  Try a Trial
European Patent Office 1631307 ⤷  Try a Trial
China 102302493 ⤷  Try a Trial
Denmark 2371361 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2005000333 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for plerixafor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2371361 CR 2019 00044 Denmark ⤷  Try a Trial 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
1411918 92033 Luxembourg ⤷  Try a Trial 92033, EXPIRES: 20240731
2371361 122019000082 Germany ⤷  Try a Trial PRODUCT NAME: PLERIXAFOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER EIN PHARMAZEUTISCH ANNEHMBARER METALLKOMPLEX DAVON; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
0619813 C300425 Netherlands ⤷  Try a Trial PRODUCT NAME: PLERIXAFOR, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH ZUURADDITIE ZOUT OF METAALCOMPLEX; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
2371361 2090003-1 Sweden ⤷  Try a Trial PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REG. NO/DATE: EU/1/09/537/001 20090804
1411918 2012/028 Ireland ⤷  Try a Trial PRODUCT NAME: PLERIXAFOR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Baxter
Medtronic
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