PRALATREXATE - Generic Drug Details
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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 Biopharma and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Pralatrexate has thirty-one patent family members in twenty-three countries.
There are two drug master file entries for pralatrexate. Two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for PRALATREXATE
International Patents: | 31 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 78 |
Clinical Trials: | 39 |
Patent Applications: | 6,567 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for PRALATREXATE |
What excipients (inactive ingredients) are in PRALATREXATE? | PRALATREXATE excipients list |
DailyMed Link: | PRALATREXATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for PRALATREXATE
Generic Entry Date for PRALATREXATE*:
Constraining patent/regulatory exclusivity:
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 PRALATREXATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Acrotech Biopharma Inc. | Phase 3 |
Otsuka Pharmaceutical Development & Commercialization, Inc. | Phase 1 |
University of Bologna | Phase 1 |
Generic filers with tentative approvals for PRALATREXATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 40MG/2ML | INJECTABLE;INJECTION |
⤷ Sign Up | ⤷ Sign Up | 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.
Pharmacology for PRALATREXATE
Drug Class | Folate Analog Metabolic Inhibitor |
Anatomical Therapeutic Chemical (ATC) Classes for PRALATREXATE
Paragraph IV (Patent) Challenges for PRALATREXATE
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 PRALATREXATE
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 | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Acrotech Biopharma | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Acrotech Biopharma | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 PRALATREXATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Acrotech Biopharma | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Acrotech Biopharma | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for PRALATREXATE
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 PRALATREXATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 1750716 | ⤷ Sign Up | |
Poland | 1750716 | ⤷ Sign Up | |
New Zealand | 576849 | Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin salts | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
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