DrugPatentWatch Database Preview
MOZOBIL Drug Profile
» See Plans and Pricing
Which patents cover Mozobil, and when can generic versions of Mozobil launch?
Mozobil is a drug marketed by Genzyme and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has fifty-two patent family members in twenty-seven countries.
The generic ingredient in MOZOBIL is plerixafor. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the plerixafor profile page.
DrugPatentWatch® Generic Entry Outlook for Mozobil
Mozobil was eligible for patent challenges on December 15, 2012.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 22, 2023. This may change due to patent challenges or generic licensing.
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There is one tentative approval for the generic drug (plerixafor), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for MOZOBIL
| International Patents: | 52 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 97 |
| Clinical Trials: | 79 |
| Patent Applications: | 3,986 |
| 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 |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for MOZOBIL
Generic Entry Date for MOZOBIL*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for MOZOBIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institutes of Health (NIH) | Phase 2 |
| Stanford University | 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 | NDA | Submissiondate |
|---|---|---|---|---|
| MOZOBIL | SOLUTION;SUBCUTANEOUS | plerixafor | 022311 | 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 | 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 MOZOBIL
| 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 MOZOBIL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 20040020075 | Start Trial |
| South Korea | 100996378 | Start Trial |
| Cyprus | 1112633 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MOZOBIL
| 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 | 27/2012 | Austria | Start Trial | PRODUCT NAME: PLERIXAFOR, GEGEBENENFALLS ALS PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER METALLKOMPLEX DAVON; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
| 1411918 | PA2012011,C1411918 | Lithuania | Start Trial | PRODUCT NAME: PLERIXAFORUM; REGISTRATION NO/DATE: EU/1/09/537/001 20090731 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
