PLERIXAFOR - Generic Drug Details

What are the generic drug sources for plerixafor and what is the scope of patent protection?

Plerixafor is the generic ingredient in two branded drugs marketed by Genzyme, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Meitheal, MSN, Teva Pharms Usa Inc, and Zydus Pharms, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for plerixafor. Twelve suppliers are listed for this compound.

Summary for PLERIXAFOR

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	156
Patent Applications:	5,856
Drug Prices:	Drug price trends for PLERIXAFOR
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

See drug prices for PLERIXAFOR

Recent Clinical Trials for PLERIXAFOR

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

Sponsor	Phase
The Leukemia and Lymphoma Society	Phase 1/Phase 2
St. Louis Children's Hospital Foundation	Phase 1/Phase 2
Rising Tide Foundation	Phase 1/Phase 2

See all PLERIXAFOR clinical trials

Pharmacology for PLERIXAFOR

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

Anatomical Therapeutic Chemical (ATC) Classes for PLERIXAFOR

L03AX	Other immunostimulants
L03A	IMMUNOSTIMULANTS
L03	IMMUNOSTIMULANTS
L	Antineoplastic and immunomodulating agents

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
Amneal	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	215334-001	Jul 24, 2023	AP	RX	No	No
Dr Reddys	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	205182-001	Jul 24, 2023	AP	RX	No	No
Meitheal	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	215698-001	Jul 24, 2023	AP	RX	No	No
Eugia Pharma	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	213672-001	Jul 24, 2023	AP	RX	No	No
Msn	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	211901-001	Jul 24, 2023	AP	RX	No	No
Genzyme	MOZOBIL	plerixafor	SOLUTION;SUBCUTANEOUS	022311-001	Dec 15, 2008	AP	RX	Yes	Yes
Gland Pharma Ltd	PLERIXAFOR	plerixafor	SOLUTION;SUBCUTANEOUS	206644-001	May 3, 2024	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