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FOLOTYN Drug Profile
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When do Folotyn patents expire, and what generic alternatives are available?
Folotyn is a drug marketed by Allos and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has forty-two patent family members in twenty-one countries.
The generic ingredient in FOLOTYN is pralatrexate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pralatrexate profile page.
Summary for FOLOTYN
| International Patents: | 42 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 51 |
| Clinical Trials: | 18 |
| Patent Applications: | 911 |
| 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
*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.
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]phenyl}formamido)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 |
| 3B1-001405 |
| 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 |
| D02LWU |
| D05589 |
| DB06813 |
| DSSTox_CID_28504 |
| DSSTox_GSID_48578 |
| DSSTox_RID_82776 |
| DTXSID3048578 |
| Folotyn (TN) |
| FT-0673988 |
| GTPL6840 |
| HE069856 |
| HE250885 |
| 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 |
| Pralatrexate |
| Pralatrexate (JAN/USAN/INN) |
| Pralatrexate [USAN:INN] |
| Pralatrexate(Folotyn) |
| Pralatrexate(Folotyn)/ |
| pralatrexato |
| pralatrexatum |
| QC-3214 |
| s1497 |
| SC-21536 |
| SCHEMBL15075302 |
| SCHEMBL21633 |
| SR-01000941578 |
| SR-01000941578-1 |
| ST24049028 |
| Tox21_112906 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Allos | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Allos | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-002 | Sep 24, 2009 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Allos | FOLOTYN | pralatrexate | SOLUTION;INTRAVENOUS | 022468-001 | Sep 24, 2009 | RX | Yes | No | ➤ 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 |
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Paragraph IV (Patent) Challenges for FOLOTYN
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Injection | 20 mg/mL and 40 mg/2 mL | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for FOLOTYN
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 6,323,205 | Combinations of 10-propargyl-10-deazaaminopterin and taxols and methods of using same in the treatment of tumors | ➤ Sign Up |
| 8,168,404 | Methods to treat cancer with 10-propargyl-10-deazaaminopterin and methods for assessing cancer for increased sensitivity to 10-propargyl-10-deazaaminopterin | ➤ Sign Up |
| 7,939,530 | Treatment of lymphoma using 10-propargyl-10-deazaaminopterin and gemcitabine | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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