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FOLOTYN Drug Profile
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Which patents cover Folotyn, and what generic alternatives are available?
Folotyn is a drug marketed by Acrotech and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has forty-four patent family members in twenty-three countries.
The generic ingredient in FOLOTYN is pralatrexate. There are two drug master file entries for this compound. Additional details are available on the pralatrexate profile page.
DrugPatentWatch® Generic Entry Outlook for Folotyn
Folotyn was eligible for patent challenges on September 24, 2013.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 16, 2022. This may change due to patent challenges or generic licensing.
There have been two 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 (pralatrexate), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for FOLOTYN
| International Patents: | 44 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 62 |
| Clinical Trials: | 19 |
| Patent Applications: | 3,237 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FOLOTYN |
| What excipients (inactive ingredients) are in FOLOTYN? | FOLOTYN excipients list |
| DailyMed Link: | FOLOTYN at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for FOLOTYN
Generic Entry Date for FOLOTYN*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS |
*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 FOLOTYN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| City of Hope Medical Center | Phase 1/Phase 2 |
| National Cancer Institute (NCI) | Phase 1/Phase 2 |
| Columbia University | Phase 3 |
ATC Classes for FOLOTYN
Paragraph IV (Patent) Challenges for FOLOTYN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FOLOTYN | SOLUTION;INTRAVENOUS | pralatrexate | 022468 | 2013-09-24 |
US Patents and Regulatory Information for FOLOTYN
| 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 | 022468-001 | Sep 24, 2009 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Y | Y | Try Before You Buy | ||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | Try Before You Buy | Try Before You Buy | Try Before You Buy | ||||
| >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 FOLOTYN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Croatia | P20080569 | Try Before You Buy |
| World Intellectual Property Organization (WIPO) | 2005117892 | Try Before You Buy |
| Poland | 1750716 | Try Before You Buy |
| South Korea | 20110081327 | Try Before You Buy |
| Austria | 407677 | Try Before You Buy |
| South Korea | 101189693 | Try Before You Buy |
| World Intellectual Property Organization (WIPO) | 9802163 | Try Before You Buy |
| >Country | >Patent Number | >Estimated Expiration |
