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Pralatrexate - Generic Drug Details
» See Plans and Pricing
What are the generic sources for pralatrexate and what is the scope of freedom to operate?
Pralatrexate
is the generic ingredient in one branded drug marketed by Acrotech and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Pralatrexate has forty-four patent family members in twenty-three countries.
There are two drug master file entries for pralatrexate. There is one tentative approval for this compound.
Summary for pralatrexate
| International Patents: | 44 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 2 |
| Bulk Api Vendors: | 62 |
| Clinical Trials: | 36 |
| Patent Applications: | 4,156 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for pralatrexate |
| DailyMed Link: | pralatrexate at DailyMed |
Recent Clinical Trials for pralatrexate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bayer | Phase 1 |
| Changchun Deng | Phase 1 |
| New York Medical College | Early Phase 1 |
Generic filers with tentative approvals for PRALATREXATE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 40MG/2ML | INJECTABLE;INJECTION |
| Start Trial | Start Trial | 20MG/1ML | INJECTABLE;INJECTION |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Paragraph IV (Patent) Challenges for PRALATREXATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FOLOTYN | SOLUTION;INTRAVENOUS | pralatrexate | 022468 | 2013-09-24 |
US Patents and Regulatory Information for pralatrexate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | 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 |
International Patents for pralatrexate
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 1750716 | Start Trial |
| Japan | 2001505537 | Start Trial |
| European Patent Office | 0944389 | Start Trial |
| Portugal | 944389 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2005117891 | Start Trial |
| Denmark | 1750716 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
