DrugPatentWatch Database Preview
FOLOTYN Drug Profile
When do Folotyn patents expire, and what generic alternatives are available?
Folotyn is a drug marketed by Acrotech and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has forty-three patent family members in twenty-two 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.
Summary for FOLOTYN
| International Patents: | 43 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 57 |
| Clinical Trials: | 19 |
| Patent Applications: | 1,248 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for FOLOTYN |
| DailyMed Link: | FOLOTYN at DailyMed |
Generic Entry Opportunity 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 |
| National Cancer Institute (NCI) | Phase 1/Phase 2 |
| Columbia University | Phase 3 |
Recent Litigation for FOLOTYN
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 |
Pharmacology for FOLOTYN
| Drug Class | Folate Analog Metabolic Inhibitor |
Synonyms for FOLOTYN
| (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 (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 |
| 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 FOLOTYN
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| FOLOTYN | SOLUTION;INTRAVENOUS | pralatrexate | 022468 | 2013-09-24 |
US Patents and Regulatory Information for FOLOTYN
| 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 | 022468-001 | 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 | Start Trial | ||||
| Acrotech | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | Start Trial | Start Trial | Y | Y | 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 FOLOTYN
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 1750716 | Start Trial |
| Germany | 69738981 | Start Trial |
| Montenegro | 01087 | Start Trial |
| Spain | 2313365 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
