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.
The generic ingredient in MOZOBIL is plerixafor. There are seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the plerixafor profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Mozobil
A generic version of MOZOBIL was approved as plerixafor by AMNEAL on July 24th, 2023.
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Summary for MOZOBIL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 110 |
| Clinical Trials: | 85 |
| Patent Applications: | 3,502 |
| Drug Prices: | Drug price information for MOZOBIL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MOZOBIL |
| What excipients (inactive ingredients) are in MOZOBIL? | MOZOBIL excipients list |
| DailyMed Link: | MOZOBIL at DailyMed |
Recent Clinical Trials for MOZOBIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Doris Duke Charitable Foundation | Phase 2 |
| David Loeb | Phase 1 |
| St. Jude Children's Research Hospital | Phase 2 |
Pharmacology for MOZOBIL
| Drug Class | Hematopoietic Stem Cell Mobilizer |
| Physiological Effect | Increased Hematopoietic Stem Cell Mobilization |
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
| 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 | AP | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >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 MOZOBIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Genzyme | MOZOBIL | plerixafor | SOLUTION;SUBCUTANEOUS | 022311-001 | Dec 15, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Genzyme | MOZOBIL | plerixafor | SOLUTION;SUBCUTANEOUS | 022311-001 | Dec 15, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Genzyme | MOZOBIL | plerixafor | SOLUTION;SUBCUTANEOUS | 022311-001 | Dec 15, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Genzyme | MOZOBIL | plerixafor | SOLUTION;SUBCUTANEOUS | 022311-001 | Dec 15, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
|---|---|---|---|
| Canada | 2125978 | AMELIORATIONS DE COMPOSES CHIMIQUES (IMPROVEMENTS IN CHEMICAL COMPOUNDS) | ⤷ Sign Up |
| Hungary | 9401786 | ⤷ Sign Up | |
| South Africa | 200400658 | METHODS TO MOBILIZE PROGENITOR STEM CELLS | ⤷ Sign Up |
| Germany | 122010000001 | ⤷ Sign Up | |
| Norway | 20040407 | ⤷ Sign Up | |
| Norway | 305984 | ⤷ Sign Up | |
| Norway | 336989 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MOZOBIL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2371361 | 2090003-1 | Sweden | ⤷ Sign Up | 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 | 92033 | Luxembourg | ⤷ Sign Up | 92033, EXPIRES: 20240731 |
| 1411918 | C 2012 019 | Romania | ⤷ Sign Up | PRODUCT NAME: PLERIXAFOR SAU O SARE SAU UN COMPLEX METALIC ACCEPTABIL FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/537/001; DATE OF NATIONAL AUTHORISATION: 20090731; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/537/001; DATE OF FIRST AUTHORISATION IN EEA: 20090731 |
| 0619813 | CA 2009 00052 | Denmark | ⤷ Sign Up | |
| 2371361 | C02371361/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: PLERIXAFOR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63139 15.08.2014 |
| 1411918 | 27/2012 | Austria | ⤷ Sign Up | PRODUCT NAME: PLERIXAFOR, GEGEBENENFALLS ALS PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER METALLKOMPLEX DAVON; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
| 1411918 | PA2012011 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
| >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.
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