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Last Updated: March 3, 2024

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.

Drug Prices for plerixafor

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Recent Clinical Trials for plerixafor

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

SponsorPhase
Rehab WeridaN/A
Peking UniversityPhase 4
Magenta Therapeutics, Inc.Phase 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
Kindos PLERIXAFOR plerixafor SOLUTION;SUBCUTANEOUS 215698-001 Jul 24, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys PLERIXAFOR plerixafor SOLUTION;SUBCUTANEOUS 205182-001 Jul 24, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 AP RX Yes Yes ⤷  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
>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

Supplementary Protection Certificates for plerixafor

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411918 PA2012011,C1411918 Lithuania ⤷  Try a Trial PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
2371361 PA2019018 Lithuania ⤷  Try a Trial PRODUCT NAME: PLERIKSAFORAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, ARBA METALO KOMPLEKSAS; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
1411918 215 5011-2012 Slovakia ⤷  Try a Trial PRODUCT NAME: PLERIXAFOR; REGISTRATION NO/DATE: EU/1/09/537/001 20090804
1411918 CA 2012 00026 Denmark ⤷  Try a Trial PRODUCT NAME: PLERIXAFOR I ALLE FORMER SOM BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/01/09/537/001 20090804
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
2371361 301031 Netherlands ⤷  Try a Trial PRODUCT NAME: PLERIXAFOR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX DAARVAN; REGISTRATION NO/DATE: EU/1/09/537/001 20090804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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