PLERIXAFOR Drug Patent Profile
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Which patents cover Plerixafor, and when can generic versions of Plerixafor launch?
Plerixafor is a drug marketed by Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Meitheal, MSN, Teva Pharms Usa Inc, and Zydus Pharms. and is included in eight NDAs.
The generic ingredient in PLERIXAFOR 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 Plerixafor
A generic version of PLERIXAFOR was approved as plerixafor by AMNEAL on July 24th, 2023.
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Summary for PLERIXAFOR
| US Patents: | 0 |
| Applicants: | 8 |
| NDAs: | 8 |
| Finished Product Suppliers / Packagers: | 10 |
| Raw Ingredient (Bulk) Api Vendors: | 110 |
| Clinical Trials: | 156 |
| Patent Applications: | 3,502 |
| Drug Prices: | Drug price information for PLERIXAFOR |
| 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 |
|---|---|
| St. Louis Children's Hospital Foundation | Phase 1/Phase 2 |
| Rising Tide Foundation | Phase 1/Phase 2 |
| The Leukemia and Lymphoma Society | Phase 1/Phase 2 |
Pharmacology for PLERIXAFOR
| Drug Class | Hematopoietic Stem Cell Mobilizer |
| Physiological Effect | Increased Hematopoietic Stem Cell Mobilization |
Anatomical Therapeutic Chemical (ATC) Classes for PLERIXAFOR
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal | PLERIXAFOR | plerixafor | SOLUTION;SUBCUTANEOUS | 215334-001 | Jul 24, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa Inc | PLERIXAFOR | plerixafor | SOLUTION;SUBCUTANEOUS | 205197-001 | Jul 24, 2023 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Gland Pharma Ltd | PLERIXAFOR | plerixafor | SOLUTION;SUBCUTANEOUS | 206644-001 | May 3, 2024 | AP | RX | No | No | ⤷ 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 |
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 |
