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 one branded drug marketed by Genzyme and is included in one NDA. 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. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for plerixafor
International Patents: | 52 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 7 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 101 |
Clinical Trials: | 148 |
Patent Applications: | 6,324 |
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 |
---|---|
4Living Biotech | Phase 2 |
National Heart, Lung, and Blood Institute (NHLBI) | Phase 1/Phase 2 |
Hugh Taylor | Early Phase 1 |
Generic filers with tentative approvals for PLERIXAFOR
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 24MG/2.1ML | SOLUTION; INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Genzyme | MOZOBIL | plerixafor | SOLUTION;SUBCUTANEOUS | 022311-001 | Dec 15, 2008 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Genzyme | MOZOBIL | plerixafor | SOLUTION;SUBCUTANEOUS | 022311-001 | Dec 15, 2008 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 | See Plans and Pricing | See Plans and Pricing |
Genzyme | MOZOBIL | plerixafor | SOLUTION;SUBCUTANEOUS | 022311-001 | Dec 15, 2008 | See Plans and Pricing | See Plans and Pricing |
>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 |
---|---|---|---|---|---|---|---|---|---|
Genzyme Europe BV | 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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for plerixafor
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 100996378 | See Plans and Pricing | |
Netherlands | 301031 | See Plans and Pricing | |
Spain | 2380009 | See Plans and Pricing | |
Lithuania | PA2019018 | See Plans and Pricing | |
Norway | 336989 | See Plans and Pricing | |
China | 102302493 | See Plans and Pricing | |
Norway | 20040407 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for plerixafor
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2371361 | PA2019018 | Lithuania | See Plans and Pricing | PRODUCT NAME: PLERIKSAFORAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, ARBA METALO KOMPLEKSAS; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
2371361 | 301031 | Netherlands | See Plans and Pricing | PRODUCT NAME: PLERIXAFOR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX DAARVAN; REGISTRATION NO/DATE: EU/1/09/537/001 20090804 |
2371361 | CA 2019 00044 | Denmark | See Plans and Pricing | PRODUCT NAME: PLERIXAFOR OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REG. NO/DATE: EU/1/09/527/001 20090731 |
0619813 | C300425 | Netherlands | See Plans and Pricing | PRODUCT NAME: PLERIXAFOR, DESGEWENST IN DE VORM VAN EEN NIET-TOXISCH ZUURADDITIE ZOUT OF METAALCOMPLEX; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
1411918 | 2012C/027 | Belgium | See Plans and Pricing | PRODUCT NAME: PLERIXAFOR SOUS TOUTES FORMES COUVERTES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/09/537/001 20090804 |
1411918 | PA2012011 | Lithuania | See Plans and Pricing | PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
2371361 | CR 2019 00044 | Denmark | See Plans and Pricing | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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