Plerixafor - Generic Drug Details

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

International Patents:	52
US Patents:	2
Tradenames:	2
Applicants:	8
NDAs:	8
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	153
Patent Applications:	6,347
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for plerixafor
What excipients (inactive ingredients) are in plerixafor?	plerixafor excipients list
DailyMed Link:	plerixafor at DailyMed

Recent Clinical Trials for plerixafor

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

Sponsor	Phase
Rehab Werida	N/A
Peking University	Phase 4
bluebird bio	Phase 2

See all plerixafor clinical trials

Pharmacology for plerixafor

Drug Class	Hematopoietic Stem Cell Mobilizer
Physiological Effect	Increased Hematopoietic Stem Cell Mobilization

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
Teva Pharms Usa Inc	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	205197-001	Jul 24, 2023	AP	RX	No	No
Amneal	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	215334-001	Jul 24, 2023	AP	RX	No	No
Zydus Pharms	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	208980-001	Jul 26, 2023	AP	RX	No	No
Msn	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	211901-001	Jul 24, 2023	AP	RX	No	No
Eugia Pharma	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	213672-001	Jul 24, 2023	AP	RX	No	No

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
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008

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

International Patents for plerixafor

Country	Patent Number	Title	Estimated Expiration
Japan	2006526646
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
European Patent Office	1631307
China	102302493
Denmark	2371361
World Intellectual Property Organization (WIPO)	2005000333

Supplementary Protection Certificates for plerixafor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2371361	CR 2019 00044	Denmark		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		92033, EXPIRES: 20240731
2371361	122019000082	Germany		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		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		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		PRODUCT NAME: PLERIXAFOR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/09/537/001 20090731