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 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

International Patents:	52
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	148
Patent Applications:	6,324
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
4Living Biotech	Phase 2
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1/Phase 2
Hugh Taylor	Early Phase 1

See all plerixafor clinical trials

Generic filers with tentative approvals for PLERIXAFOR

Applicant	Application No.	Strength	Dosage Form
		24MG/2.1ML	SOLUTION; 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

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

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

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

International Patents for plerixafor

Country	Patent Number	Title	Estimated Expiration
South Korea	100996378
Netherlands	301031
Spain	2380009
Lithuania	PA2019018
Norway	336989
China	102302493
Norway	20040407

Supplementary Protection Certificates for plerixafor

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2371361	PA2019018	Lithuania		PRODUCT NAME: PLERIKSAFORAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, ARBA METALO KOMPLEKSAS; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
2371361	301031	Netherlands		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		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		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		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		PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
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