FOLOTYN Drug Patent 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. One supplier is listed 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 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 68 |
Clinical Trials: | 23 |
Patent Applications: | 3,852 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for FOLOTYN |
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 |
Jennifer Amengual | Phase 3 |
Columbia University | Phase 3 |
Pharmacology for FOLOTYN
Drug Class | Folate Analog Metabolic Inhibitor |
Anatomical Therapeutic Chemical (ATC) Classes for FOLOTYN
Paragraph IV (Patent) Challenges for FOLOTYN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FOLOTYN | Injection | pralatrexate | 20 mg/mL and 40 mg/2 mL | 022468 | 4 | 2013-09-24 |
US Patents and Regulatory Information for FOLOTYN
FOLOTYN is protected by three US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of FOLOTYN is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting FOLOTYN
Purified compositions of 10-propargyl-10-deazaaminopterin and methods of using same in the treatment of tumors
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
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 | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | 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 |
EU/EMA Drug Approvals for FOLOTYN
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Allos Therapeutics Ltd | Folotyn | pralatrexate | EMEA/H/C/002096 treatment of peripheral T-cell lymphoma, |
Refused | no | no | yes | 2012-06-21 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for FOLOTYN
See the table below for patents covering FOLOTYN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5005532 | See Plans and Pricing | |
New Zealand | 551082 | Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin | See Plans and Pricing |
South Korea | 20110081327 | TREATMENT OF T-CELL LYMPHOMA USING 10-PROPARGYL-10-DEAZAAMINOPTERIN | See Plans and Pricing |
Australia | 2005249516 | Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin | See Plans and Pricing |
Slovenia | 1750716 | See Plans and Pricing | |
New Zealand | 576849 | Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin salts | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 9802163 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |