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Last Updated: May 29, 2023

MOZOBIL Drug Patent Profile


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Which patents cover Mozobil, and when can generic versions of Mozobil launch?

Mozobil is a drug marketed by Genzyme and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has fifty-two patent family members in twenty-seven countries.

The generic ingredient in MOZOBIL is plerixafor. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the plerixafor profile page.

DrugPatentWatch® Generic Entry Outlook for Mozobil

Mozobil was eligible for patent challenges on December 15, 2012.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 22, 2023. This may change due to patent challenges or generic licensing.

There have been seven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are five tentative approvals for the generic drug (plerixafor), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for MOZOBIL
Drug Prices for MOZOBIL

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for MOZOBIL
Generic Entry Date for MOZOBIL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for MOZOBIL

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

SponsorPhase
Albert Einstein College of MedicinePhase 1
Doris Duke Charitable FoundationPhase 2
David LoebPhase 1

See all MOZOBIL clinical trials

Pharmacology for MOZOBIL
Paragraph IV (Patent) Challenges for MOZOBIL
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 MOZOBIL

MOZOBIL is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of MOZOBIL is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting MOZOBIL

Methods to mobilize progenitor/stem cells
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE IN COMBINATION WITH GRANULOCYTE-COLONY STIMULATING FACTOR (G-CSF) TO MOBILIZE HEMATOPOIETIC STEM CELLS TO PERIPHERAL BLOOD FOR COLLECTION & SUBSEQUENT AUTOLOGOUS TRANSPLANTATION IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA & MULTIPLE MYELOMA

Methods to mobilize progenitor/stem cells
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: USE IN COMBINATION WITH GRANULOCYTE-COLONY STIMULATING FACTOR (G-CSF) TO MOBILIZE HEMATOPOIETIC STEM CELLS TO PERIPHERAL BLOOD FOR COLLECTION & SUBSEQUENT AUTOLOGOUS TRANSPLANTATION IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA & MULTIPLE MYELOMA

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Genzyme MOZOBIL plerixafor SOLUTION;SUBCUTANEOUS 022311-001 Dec 15, 2008 RX Yes Yes ⤷  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

EU/EMA Drug Approvals for MOZOBIL

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 MOZOBIL

See the table below for patents covering MOZOBIL around the world.

Country Patent Number Title Estimated Expiration
Finland 942849 ⤷  Try a Trial
Slovenia 1411918 ⤷  Try a Trial
Canada 2455559 METHODES DE MOBILISATION DE CELLULES SOUCHES/EMBRYONNAIRES (METHODS TO MOBILIZE PROGENITOR/STEM CELLS) ⤷  Try a Trial
Australia 661086 ⤷  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
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MOZOBIL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1411918 27/2012 Austria ⤷  Try a Trial PRODUCT NAME: PLERIXAFOR, GEGEBENENFALLS ALS PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER METALLKOMPLEX DAVON; REGISTRATION NO/DATE: EU/1/09/537/001 20090731
0619813 SPC038/2009 Ireland ⤷  Try a Trial SPC038/2009: 20101001, EXPIRES: 20171215
1411918 PA2012011 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
2371361 2019C/544 Belgium ⤷  Try a Trial PRODUCT NAME: MOZOBIL - PLERIXAFOR; AUTHORISATION NUMBER AND DATE: EU/1/09/537/001 20090804
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.