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 and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Pralatrexate has forty-four patent family members in twenty-three countries.
There are two drug master file entries for pralatrexate. One supplier is listed for this compound.
Summary for pralatrexate
| International Patents: | 44 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 68 |
| Clinical Trials: | 38 |
| Patent Applications: | 6,365 |
| Formulation / Manufacturing: | see details |
| 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 |
Recent Clinical Trials for pralatrexate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Otsuka Pharmaceutical Development & Commercialization, Inc. | Phase 1 |
| University of Bologna | Phase 1 |
| Merck Sharp & Dohme Corp. | Phase 1 |
Pharmacology for pralatrexate
| Drug Class | Folate Analog Metabolic Inhibitor |
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 | 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 | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | 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 | 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 | ||||
| >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 pralatrexate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 602005009176 | See Plans and Pricing | |
| Austria | 405272 | See Plans and Pricing | |
| China | 1960734 | Treatment of t-cell lymphoma using 10-propargyl-10-deazaaminopterin | See Plans and Pricing |
| Germany | 69738981 | See Plans and Pricing | |
| Brazil | PI0510895 | formulação farmacêutica de 10-propargila-10-deazaaminopterina para tratamento de linfoma de célula t | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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