DrugPatentWatch Database Preview
Pralatrexate - Generic Drug Details
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. Two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for pralatrexate
| International Patents: | 44 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 57 |
| Clinical Trials: | 35 |
| Patent Applications: | 2,345 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for pralatrexate |
| DailyMed Link: | pralatrexate at DailyMed |
Recent Clinical Trials for pralatrexate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Alabama at Birmingham | Early Phase 1 |
| New York Medical College | Early Phase 1 |
| National Cancer Institute (NCI) | Phase 1/Phase 2 |
Recent Litigation for pralatrexate
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| ALLOS THERAPEUTICS, INC. v. DR. REDDY'S LABORATORIES, INC. | 2014-07-07 |
| Allos Therapeutics Inc. v. Fresenius Kabi USA, LLC | 2014-06-19 |
Generic filers with tentative approvals for PRALATREXATE
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 40MG/2ML | INJECTABLE;INJECTION |
| Start Trial | Start Trial | 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 |
Synonyms for pralatrexate
| (2S)-2-((4-((1RS)-1-((2,4-Diaminopteridin-6-yl)methyl)but-3-ynyl)benzoyl)amino)pentanedioic acid |
| (2S)-2-({4-[1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl]benzoyl}amino)pentanedioic acid |
| (2S)-2-(4-(1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl)benzamido)pentanedioic acid |
| (2S)-2-[[4-[1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl]benzoyl]amino]pentanedioic acid |
| (2S)-2-[[4-[1-[(2,4-diaminopteridin-6-yl)methyl]but-3-ynyl]benzoyl]amino]pentanedioic acid |
| (4-(1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl)benzoyl)-L-glutamic acid |
| 10-Propargyl-10-deazaaminopterin |
| 146464-95-1 |
| 2667AH |
| 464P951 |
| AB00443251_04 |
| AB00443251-02 |
| AB0095450 |
| AB2000123 |
| ABP000543 |
| AC-28388 |
| AC1L3WHA |
| AK162224 |
| AKOS015966891 |
| AM84423 |
| AN-6340 |
| API0005288 |
| AX8248565 |
| BCPP000101 |
| CAS-146464-95-1 |
| CHEBI:71223 |
| CHEMBL1201746 |
| CS-0504 |
| D05589 |
| DB06813 |
| DSSTox_CID_28504 |
| DSSTox_GSID_48578 |
| DSSTox_RID_82776 |
| DTXSID3048578 |
| EX-A2142 |
| Folotyn |
| Folotyn (TN) |
| FT-0673988 |
| GTPL6840 |
| HSDB 7786 |
| HY-10446 |
| J-008227 |
| KS-00001CSH |
| L-Glutamic acid, N-(4-(1-((2,4-diamino-6-pteridinyl)methyl)-3-butynyl)benzoyl)- |
| MolPort-009-679-397 |
| N-(4-(1-((2,4-Diamino-6-pteridinyl)methyl)-3-butynyl)benzoyl)-L-glutamic acid |
| N-[4-[1-[(2,4-Diamino-6-pteridinyl)methyl]-3-butyn-1-yl]benzoyl]-L-glutamic Acid |
| N-[4-[1-[(2,4-Diamino-6-pteridinyl)methyl]-3-butynyl]benzoyl]-L-glutamic Acid |
| N-{4-[1-(2,4-diaminopteridin-6-yl)pent-4-yn-2-yl]benzoyl}-L-glutamic acid |
| NCGC00242596-01 |
| NSC-754230 |
| NSC754230 |
| OGSBUKJUDHAQEA-WMCAAGNKSA-N |
| PDX |
| Pralatrexate (JAN/USAN/INN) |
| Pralatrexate [USAN:INN] |
| Pralatrexate(Folotyn) |
| Pralatrexate(Folotyn)/ |
| pralatrexato |
| pralatrexatum |
| QC-3214 |
| s1497 |
| SB17353 |
| SC-21536 |
| SCHEMBL15075302 |
| SCHEMBL21633 |
| SR-01000941578 |
| SR-01000941578-1 |
| ST24049028 |
| SW220187-1 |
| Tox21_112906 |
Paragraph IV (Patent) Challenges for PRALATREXATE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FOLOTYN | SOLUTION;INTRAVENOUS | pralatrexate | 022468 | 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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >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 | Estimated Expiration |
|---|---|---|
| Japan | 5005532 | Start Trial |
| Norway | 20065971 | Start Trial |
| Portugal | 1750716 | Start Trial |
| European Patent Office | 2258702 | Start Trial |
| Montenegro | 01087 | Start Trial |
| Hong Kong | 1177901 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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 verifification 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.
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
NCE-1 Patent Challenge Dates 2019 - 2020
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.