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
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Questions you can ask:
- What is the 5 year forecast for FOLOTYN?
- What are the global sales for FOLOTYN?
- What is Average Wholesale Price for FOLOTYN?
Summary for FOLOTYN
International Patents: | 31 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 78 |
Clinical Trials: | 24 |
Patent Applications: | 4,082 |
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 |
---|---|
Acrotech Biopharma Inc. | Phase 3 |
City of Hope Medical Center | Phase 1/Phase 2 |
Jennifer Amengual | Phase 3 |
Pharmacology for FOLOTYN
Drug Class | Folate Analog Metabolic Inhibitor |
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 ⤷ Subscribe.
This potential generic entry date is based on patent ⤷ Subscribe.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Acrotech Biopharma | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Acrotech Biopharma | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 | ⤷ Subscribe | ⤷ Subscribe |
Acrotech Biopharma | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | ⤷ Subscribe | ⤷ Subscribe |
>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
See the table below for patents covering FOLOTYN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 5271677 | ⤷ Subscribe | |
Japan | 2009091361 | PURIFIED COMPOSITION OF 10-PROPARGYL-10-DEAZAAMINOPTERIN AND METHOD OF USING THE COMPOUND IN TREATMENT OF TUMOR | ⤷ Subscribe |
Germany | 69738981 | ⤷ Subscribe | |
>Country | >Patent Number | >Title | >Estimated Expiration |
FOLOTYN Market Analysis and Financial Projection Experimental
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