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 Biopharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has thirty-one patent family members in twenty-three countries.
The generic ingredient in FOLOTYN is pralatrexate. There are two drug master file entries for this compound. Two suppliers are 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 May 31, 2025. 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: | 31 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 77 |
Clinical Trials: | 23 |
Patent Applications: | 4,034 |
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 Loss of Exclusivity (LOE) 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 |
Columbia University | Phase 3 |
Jennifer Amengual | 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 two US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of FOLOTYN is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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
Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 Biopharma | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Acrotech Biopharma | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Acrotech Biopharma | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Acrotech Biopharma | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 FOLOTYN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Acrotech Biopharma | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Acrotech Biopharma | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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
When does loss-of-exclusivity occur for FOLOTYN?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 05249516
Estimated Expiration: ⤷ Try a Trial
Austria
Patent: 5272
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0510895
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 65968
Estimated Expiration: ⤷ Try a Trial
China
Patent: 60734
Estimated Expiration: ⤷ Try a Trial
Patent: 2824346
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0080569
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 50716
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 50716
Estimated Expiration: ⤷ Try a Trial
Germany
Patent: 2005009176
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 77901
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 05532
Estimated Expiration: ⤷ Try a Trial
Patent: 08501038
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 06013559
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 087
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 1082
Estimated Expiration: ⤷ Try a Trial
Patent: 6849
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 7276
Estimated Expiration: ⤷ Try a Trial
Patent: 065971
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 50716
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 50716
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 622
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 50716
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0609266
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1189692
Estimated Expiration: ⤷ Try a Trial
Patent: 1189693
Estimated Expiration: ⤷ Try a Trial
Patent: 070035490
Estimated Expiration: ⤷ Try a Trial
Patent: 110081327
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 13365
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering FOLOTYN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Montenegro | 01087 | TRETMAN LIMFOMA T-ĆELIJA PRIMJENOM 10-PROPARGIL-10-DEAZAAMINOPTERINA (TREATMENT OF T-CELL LYMPHOMA USING 10-PROPARGYL-10-DEAZAAMINOPTERIN) | ⤷ Try a Trial |
Serbia | 50622 | TRETMAN LIMFOMA T-ĆELIJA PRIMENOM 10-PROPARGIL-10-DIAZAAMINOPTERINA (TREATMENT OF T-CELL LYMPHOMA USING 10-PROPARGYL-10-DEAZAAMINOPTERIN) | ⤷ Try a Trial |
Spain | 2313737 | ⤷ Try a Trial | |
Austria | 405272 | ⤷ Try a Trial | |
European Patent Office | 1750716 | TRAITEMENT DU LYMPHOME T UTILISANT 10-PROPARGYL-10-DEAZAAMINOPTERINE (TREATMENT OF T-CELL LYMPHOMA USING 10-PROPARGYL-10-DEAZAAMINOPTERIN) | ⤷ Try a Trial |
South Korea | 20070035490 | Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin | ⤷ Try a Trial |
Brazil | PI0510895 | formulação farmacêutica de 10-propargila-10-deazaaminopterina para tratamento de linfoma de célula t | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |