MOZOBIL Drug Patent Profile
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When do Mozobil patents expire, and what generic alternatives are available?
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. Eleven 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 |
---|---|
Albert Einstein College of Medicine | Phase 1 |
Doris Duke Charitable Foundation | Phase 2 |
David Loeb | Phase 1 |
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 |
---|---|---|---|
European Patent Office | 1223166 | ⤷ Sign Up | |
Portugal | 2371361 | ⤷ Sign Up | |
New Zealand | 530169 | Methods to mobilize progenitor/stem cells | ⤷ Sign Up |
Spain | 2224096 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MOZOBIL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1411918 | 215 5011-2012 | Slovakia | ⤷ Sign Up | PRODUCT NAME: PLERIXAFOR; REGISTRATION NO/DATE: EU/1/09/537/001 20090804 |
1411918 | 1290023-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: PLERIXAFOR, VALFRITT I FORMEN AV ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/09/534/001 20090804 |
2371361 | 2019C/544 | Belgium | ⤷ Sign Up | PRODUCT NAME: MOZOBIL - PLERIXAFOR; AUTHORISATION NUMBER AND DATE: EU/1/09/537/001 20090804 |
1411918 | 92033 | Luxembourg | ⤷ Sign Up | 92033, EXPIRES: 20240731 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |