MOZOBIL Drug Patent Profile
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When do Mozobil patents expire, 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. Ten 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.
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: | 3,881 |
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 |
---|---|
David Loeb | Phase 1 |
St. Jude Children's Research Hospital | Phase 2 |
Albert Einstein College of Medicine | Phase 1 |
Pharmacology for MOZOBIL
Drug Class | Hematopoietic Stem Cell Mobilizer |
Physiological Effect | Increased Hematopoietic Stem Cell Mobilization |
Anatomical Therapeutic Chemical (ATC) Classes 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
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 | ⤷ 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Genzyme | MOZOBIL | plerixafor | SOLUTION;SUBCUTANEOUS | 022311-001 | Dec 15, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Genzyme | MOZOBIL | plerixafor | SOLUTION;SUBCUTANEOUS | 022311-001 | Dec 15, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Genzyme | MOZOBIL | plerixafor | SOLUTION;SUBCUTANEOUS | 022311-001 | Dec 15, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Slovenia | 1411918 | ⤷ Try a Trial | |
Norway | 305984 | ⤷ Try a Trial | |
Netherlands | 301031 | ⤷ Try a Trial | |
Mexico | 9207316 | MEJORAS EN COMPUESTOS QUIMICOS. | ⤷ Try a Trial |
Russian Federation | 2309741 | СПОСОБЫ АКТИВАЦИИ КЛЕТОК-ПРЕДШЕСТВЕННИКОВ/СТВОЛОВЫХ КЛЕТОК (METHODS FOR ACTIVATION OF CELLS-PRECURSORS/STEM CELLS) | ⤷ Try a Trial |
Luxembourg | 92033 | ⤷ 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 |
---|---|---|---|---|
2371361 | C02371361/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFOR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 63139 15.08.2014 |
2371361 | LUC00139 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFOR EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE OU UN COMPLEXE METALLIFERE QUI EN DERIVE; AUTHORISATION NUMBER AND DATE: EU/1/09/537/001 20090804 |
2371361 | 5/2020 | Austria | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFOR, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES ODER EINES PHARMAZEUTISCH ANNEHMBAREN METALLKOMPLEXES; REGISTRATION NO/DATE: EU/1/09/537/001 20090804 |
1411918 | C 2012 019 | Romania | ⤷ Try a Trial | 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 |
1411918 | 132012902063874 | Italy | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFOR(MOZOBIL); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/09/537/001, 20090731 |
1411918 | PA2012011,C1411918 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |