Plerixafor - Generic Drug Details
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What are the generic drug sources for plerixafor and what is the scope of freedom to operate?
Plerixafor
is the generic ingredient in two branded drugs marketed by Genzyme, Amneal, Dr Reddys, Eugia Pharma, Kindos, MSN, Teva Pharms Usa Inc, and Zydus Pharms, and is included in eight NDAs. 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. Ten suppliers are listed for this compound.
Summary for plerixafor
International Patents: | 52 |
US Patents: | 2 |
Tradenames: | 2 |
Applicants: | 8 |
NDAs: | 8 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 10 |
Raw Ingredient (Bulk) Api Vendors: | 110 |
Clinical Trials: | 153 |
Patent Applications: | 6,347 |
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 |
---|---|
Rehab Werida | N/A |
Peking University | Phase 4 |
bluebird bio | Phase 2 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dr Reddys | PLERIXAFOR | plerixafor | SOLUTION;SUBCUTANEOUS | 205182-001 | Jul 24, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Teva Pharms Usa Inc | PLERIXAFOR | plerixafor | SOLUTION;SUBCUTANEOUS | 205197-001 | Jul 24, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Amneal | PLERIXAFOR | plerixafor | SOLUTION;SUBCUTANEOUS | 215334-001 | Jul 24, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Zydus Pharms | PLERIXAFOR | plerixafor | SOLUTION;SUBCUTANEOUS | 208980-001 | Jul 26, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Msn | PLERIXAFOR | plerixafor | SOLUTION;SUBCUTANEOUS | 211901-001 | Jul 24, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Eugia Pharma | PLERIXAFOR | plerixafor | SOLUTION;SUBCUTANEOUS | 213672-001 | Jul 24, 2023 | AP | RX | No | No | ⤷ 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 plerixafor
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 plerixafor
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 plerixafor
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2006526646 | ⤷ 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 |
European Patent Office | 1631307 | ⤷ Try a Trial | |
China | 102302493 | ⤷ Try a Trial | |
Denmark | 2371361 | ⤷ Try a Trial | |
World Intellectual Property Organization (WIPO) | 2005000333 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for plerixafor
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2371361 | CR 2019 00044 | Denmark | ⤷ Try a Trial | 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 |
1411918 | 92033 | Luxembourg | ⤷ Try a Trial | 92033, EXPIRES: 20240731 |
2371361 | 122019000082 | Germany | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER EIN PHARMAZEUTISCH ANNEHMBARER METALLKOMPLEX DAVON; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
0619813 | C300425 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFOR, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH ZUURADDITIE ZOUT OF METAALCOMPLEX; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
2371361 | 2090003-1 | Sweden | ⤷ Try a Trial | 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 | 2012/028 | Ireland | ⤷ Try a Trial | PRODUCT NAME: PLERIXAFOR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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