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Plerixafor - Generic Drug Details
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 patent family members in twenty-seven countries.
There are seven drug master file entries for plerixafor. One supplier is listed for this compound.
Summary for plerixafor
| International Patents: | 50 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 7 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 90 |
| Clinical Trials: | 131 |
| Patent Applications: | 2,282 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for plerixafor |
| DailyMed Link: | plerixafor at DailyMed |
Recent Clinical Trials for plerixafor
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| General Oncology, Inc. | Phase 2 |
| American Association for Cancer Research | Phase 2 |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | 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 | NDA | Submissiondate |
|---|---|---|---|---|
| MOZOBIL | SOLUTION;SUBCUTANEOUS | plerixafor | 022311 | 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 | Start Trial | Start Trial | Start Trial | ||||
| Genzyme | MOZOBIL | plerixafor | SOLUTION;SUBCUTANEOUS | 022311-001 | Dec 15, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Start 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 | Start Trial | Start Trial |
| Genzyme | MOZOBIL | plerixafor | SOLUTION;SUBCUTANEOUS | 022311-001 | Dec 15, 2008 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for plerixafor
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20040020075 | Start Trial |
| European Patent Office | 1411918 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03011277 | Start Trial |
| Slovenia | 2371361 | Start Trial |
| Germany | 122012000044 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for plerixafor
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2371361 | 122019000082 | Germany | Start Trial | PRODUCT NAME: PLERIXAFOR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER EIN PHARMAZEUTISCH ANNEHMBARER METALLKOMPLEX DAVON; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
| 1411918 | 2012/028 | Ireland | Start Trial | PRODUCT NAME: PLERIXAFOR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR METAL COMPLEX THEREOF; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
| 1411918 | 1290023-9 | Sweden | Start Trial | PRODUCT NAME: PLERIXAFOR, VALFRITT I FORMEN AV ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/09/534/001 20090804 |
| 2371361 | 301031 | Netherlands | Start Trial | PRODUCT NAME: PLERIXAFOR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF METAALCOMPLEX DAARVAN; REGISTRATION NO/DATE: EU/1/09/537/001 20090804 |
| 1411918 | 132012902063874 | Italy | Start Trial | PRODUCT NAME: PLERIXAFOR(MOZOBIL); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/09/537/001, 20090731 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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