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Pemetrexed disodium - Generic Drug Details
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What are the generic drug sources for pemetrexed disodium and what is the scope of freedom to operate?
Pemetrexed disodium
is the generic ingredient in one branded drug marketed by Lilly and is included in one NDA. There is one patent protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Pemetrexed disodium has eighteen patent family members in eleven countries.
There are twenty-nine drug master file entries for pemetrexed disodium. One supplier is listed for this compound. There are two tentative approvals for this compound.
Summary for pemetrexed disodium
| International Patents: | 18 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 29 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 189 |
| Clinical Trials: | 92 |
| Patent Applications: | 5,413 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for pemetrexed disodium |
| DailyMed Link: | pemetrexed disodium at DailyMed |
Recent Clinical Trials for pemetrexed disodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, San Francisco | Phase 2 |
| Merck Sharp & Dohme Corp. | Phase 2 |
| Sun Yat-sen University | Phase 2 |
Recent Litigation for pemetrexed disodium
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Eli Lilly and Company v. Eagle Pharmaceuticals, Inc. | 2017-09-11 |
| ELI LILLY AND COMPANY v. HOSPIRA, INC. | 2016-12-21 |
| ELI LILLY AND COMPANY v. DR. REDDY'S LABORATORIES, LTD. | 2016-02-05 |
See all pemetrexed disodium litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Apotex Inc. | 2016-07-14 |
| Wockhardt Bio AG | 2016-07-08 |
| Apotex Inc. | 2016-07-01 |
Generic filers with tentative approvals for PEMETREXED DISODIUM
| Applicant | Application No. | Strength | Dosage Form |
| Start Trial | Start Trial | 500MG | INJECTABLE;INJECTION |
| Start Trial | Start Trial | 100MG | INJECTABLE;INJECTION |
| Start Trial | Start Trial | 100MG | 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 pemetrexed disodium
| Drug Class | Folate Analog Metabolic Inhibitor |
| Mechanism of Action | Folic Acid Metabolism Inhibitors |
Medical Subject Heading (MeSH) Categories for pemetrexed disodium
Synonyms for pemetrexed disodium
| (2S)-2-[[4-[2-(2-amino-4-oxo-1,7-dihydropyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]pentanedioic acid |
| (S)-2-(4-(2-(2-Amino-4-oxo-4,7-dihydro-1H-pyrrolo-[2,3-d]pyrimidin-5-yl)ethyl)benzamido)pentanedioic acid |
| (S)-2-(4-(2-(2-Amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzamido)pentanedioic |
| (S)-2-(4-(2-(2-Amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzamido)pentanedioic acid |
| (S)-2-(4-(2-(2-amino-4-oxo-4,7-dihydro-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzamido)pentanedioic acid |
| 04Q9AIZ7NO |
| 137281-23-3 |
| 150399-23-8 |
| 1juj |
| 2-{4-[2-(2-AMINO-4-OXO-4,7-DIHYDRO-3H-PYRROLO[2,3-D]PYRIMIDIN-5-YL)-ETHYL]-BENZOYLAMINO}-PENTANEDIOIC ACID |
| 281P233 |
| 2PKU919BA9 |
| 357166-29-1 |
| 357166-30-4 |
| 399P238 |
| 41413-EP2270012A1 |
| 41413-EP2270013A1 |
| 41413-EP2305681A1 |
| 41413-EP2311838A1 |
| 41421-EP2270012A1 |
| 41421-EP2270013A1 |
| 41421-EP2305681A1 |
| 41421-EP2311838A1 |
| 4DW |
| 89077-EP2270012A1 |
| 89077-EP2270013A1 |
| 89077-EP2305681A1 |
| 89080-EP2270013A1 |
| 89080-EP2305681A1 |
| 9T47E4OM16 |
| AB01273937-01 |
| AC-1326 |
| AC-15436 |
| AC-1701 |
| AC-23353 |
| AC-8339 |
| AC1L9JT6 |
| AC1OCF51 |
| AJ-26845 |
| AK-72902 |
| AK325951 |
| AKOS015896253 |
| AKOS015961984 |
| AKOS016005851 |
| AKOS016340523 |
| AKOS025149477 |
| AKOS025392176 |
| Alimta |
| Alimta (TN) |
| Alimta (TN) (Lilly) |
| AN-28733 |
| AN-28734 |
| API0024628 |
| AS-17891 |
| AS-30680 |
| BC215781 |
| BC216030 |
| BCP22709 |
| BDBM50027656 |
| BG0632 |
| BR-72902 |
| C20H19N5Na2O6 |
| C20H19N5O6.2Na.7H2O |
| C20H21N5O6 |
| C40H48N10Na4O17 |
| CAS-150399-23-8 |
| CCG-213071 |
| CCG-221272 |
| CHEBI:63616 |
| CHEBI:63722 |
| CHEBI:63723 |
| CHEMBL225072 |
| CHEMBL2360464 |
| CP0067 |
| CP0119 |
| CS-1297 |
| CS-1298 |
| CS-W004541 |
| CTK8E6673 |
| D03828 |
| D06503 |
| D07472 |
| D10596 |
| DB-024764 |
| DB00642 |
| disodium (2S)-2-({4-[2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl}amino)pentanedioate |
| disodium (2S)-2-[[4-[2-(2-amino-4-oxo-1,7-dihydropyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]pentanedioate |
| disodium (2S)-2-[[4-[2-(2-amino-4-oxo-1,7-dihydropyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]pentanedioate heptahydrate |
| Disodium N-(p-(2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo(2,3-d)pyrimidin-5-yl)ethyl)benzoyl)-L-glutamate |
| disodium N-{4-[2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl}-L-glutamate |
| disodium N-{4-[2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl}-L-glutamate--water (1/7) |
| disodium;(2S)-2-[[4-[2-(2-amino-4-oxo-1,7-dihydropyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]pentanedioate;heptahydrate |
| DSSTox_CID_26660 |
| DSSTox_GSID_46660 |
| DSSTox_RID_81803 |
| DTXSID10189239 |
| DTXSID2048329 |
| DTXSID50189238 |
| DTXSID8046660 |
| EX-A836 |
| F4GSH45R4C |
| FT-0659328 |
| FT-0689445 |
| H518 |
| HMS3264H07 |
| HMS3715P06 |
| HSDB 7316 |
| HY-10820 |
| HY-10820A |
| I06-2128 |
| J-502393 |
| KB-303015 |
| KB-78231 |
| KB-79792 |
| KB-79793 |
| KS-00000GW0 |
| KS-00000XJK |
| KS-00001092 |
| KS-1185 |
| KS-5001 |
| L-Glutamic acid, N-(4-(2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo(2,3-d)pyrimidin-5-yl)ethyl)benzoyl)- |
| L-Glutamic acid, N-(4-(2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo(2,3-d)pyrimidin-5-yl)ethyl)benzoyl)-, disodium salt |
| L-Glutamic acid, N-(4-(2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo(2,3-d)pyrimidin-5-yl)ethyl)benzoyl)-, sodium salt, hydrate (2:4:5) |
| L-Glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4- 8 oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, disodium salt, heptahydrate |
| L-Glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-, disodium salt, heptahydrate |
| L-Glutamic acid, N-[4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]- |
| L-Glutamic acid,3-d]pyrimidin-5-yl]ethyl]benzoyl]- |
| LY 231,514 |
| LY 231514 |
| LY-2315 |
| LY-231514 |
| LY-231514 Disodium Hydrate |
| LY231514 |
| LY231514 disodium |
| LYA |
| MolPort-003-849-796 |
| MolPort-005-935-364 |
| MolPort-016-638-470 |
| MolPort-020-179-988 |
| MolPort-023-220-664 |
| MolPort-028-744-755 |
| MolPort-046-033-448 |
| N-({4-[2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]phenyl}carbonyl)-L-glutamic acid |
| N-(4-(2-(2-Amino-3,4-dihydro-4-oxo-7H-pyrrolo(2,3-d)pyrimdin-5-yl)ethyl)benzoyl)glutamic acid |
| N-(4-[2-(2-amino-4,7-Dihydro-4-Oxo-1H-Pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl)-L-Glutamic Acid |
| N-(4-[2-(2-Amino-4,7-Dihydro-4-Oxo-1H-Pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl)-L-Glutamic Acid Disodium Salt |
| N-(4-[2-(2-Amino-4,7-Dihydro-4-Oxo-1H-Pyrrolo[2,3-d]pyrimidin-5yl)ethyl]benzoyl)-L-Glutamic Acid Disodium Salt |
| N-[4-[2-(2-amino-3,4-dihydro-4-oxo-7h-pyrrolo[2,3-d]pyrimi-din-5-yl)ethyl]benzoyl]l-glutamic acid |
| N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid |
| N-[4-[2-(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid disodium |
| N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid disodium salt |
| N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid disodium salt hydrate |
| N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2.3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid disodium salt |
| N-[4-[2-(2-amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid |
| N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt Heptahydrate |
| N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid disodium salt hydrate |
| N-[4-[2-[2-Amino-4,7-dihydro-4-oxo-3H-pyrrolo[2,3-d]pyrimidin-5-yl]ethyl]benzoyl]glutamic acid |
| N-[4-[2(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo [2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid |
| N-[4-[2(2-amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic acid |
| N-[4[2-(-amino-3,4-dihydro-4-oxo-7h-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-l-glutamate sodium salt |
| N-{4-[2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl}-L-glutamic acid |
| NCGC00167486-01 |
| NCGC00167517-01 |
| NCGC00242485-01 |
| NSC-698037 |
| NSC698037 |
| NYDXNILOWQXUOF-GXKRWWSZSA-L |
| P2288 |
| Pemetrexed |
| Pemetrexed (disodium) |
| Pemetrexed (INN) |
| Pemetrexed (TN) |
| Pemetrexed [INN:BAN] |
| Pemetrexed accord (TN) |
| Pemetrexed acid |
| Pemetrexed disodium (USAN) |
| Pemetrexed disodium [USAN] |
| Pemetrexed disodium 2.5 hydrate |
| PEMETREXED DISODIUM 5/2 hydrate |
| Pemetrexed disodium hemipentahydrate |
| Pemetrexed disodium heptahydrate |
| Pemetrexed disodium hepthydrate |
| Pemetrexed disodium hydrate |
| Pemetrexed disodium salt |
| Pemetrexed Disodium Salt Heptahydrate |
| Pemetrexed disodium, anhydrous |
| Pemetrexed sodium hemipentahydrate (JAN) |
| Pemetrexed sodium hydrate |
| Pemetrexed sodium hydrate (2:4:5) |
| Pemetrexed sodium hydrate (JAN) |
| Premetred disodium |
| Premetrexed [Common mis-spelling] |
| QJVSMHJWAOSBMD-MYXYZBIASA-L |
| Rolazar |
| RP17940 |
| RP17947 |
| S-4927 |
| s1135 |
| SC-22444 |
| SC-25136 |
| SCHEMBL108860 |
| SCHEMBL18348 |
| SCHEMBL7968 |
| sodium (S)-2-(4-(2-(2-amino-4-oxo-4,7-dihydro-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl)benzamido)pentanedioate |
| tetrasodium (2S)-2-[[4-[2-(2-amino-4-oxo-1,7-dihydropyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]amino]pentanedioate pentahydrate |
| Tifolar |
| Tox21_112487 |
| UNII-04Q9AIZ7NO |
| UNII-2PKU919BA9 |
| UNII-9T47E4OM16 |
| UNII-F4GSH45R4C |
| US9422297, Pemetrexed |
| V2356 |
| WBXPDJSOTKVWSJ-ZDUSSCGKSA-N |
| X5918 |
| ZCTCZKWJFTYNMZ-WKUCUCPSSA-J |
| ZINC1540998 |
Paragraph IV (Patent) Challenges for PEMETREXED DISODIUM
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ALIMTA | POWDER;INTRAVENOUS | pemetrexed disodium | 021462 | 2016-10-06 |
| ALIMTA | POWDER;INTRAVENOUS | pemetrexed disodium | 021462 | 2012-06-27 |
| ALIMTA | POWDER;INTRAVENOUS | pemetrexed disodium | 021462 | 2008-07-01 |
| ALIMTA | POWDER;INTRAVENOUS | pemetrexed disodium | 021462 | 2008-02-04 |
US Patents and Regulatory Information for pemetrexed disodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-001 | Feb 4, 2004 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-002 | Sep 7, 2007 | RX | Yes | Yes | Start Trial | Start Trial | 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 |
Expired US Patents for pemetrexed disodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-002 | Sep 7, 2007 | Start Trial | Start Trial |
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-001 | Feb 4, 2004 | Start Trial | Start Trial |
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-001 | Feb 4, 2004 | Start Trial | Start Trial |
| Lilly | ALIMTA | pemetrexed disodium | POWDER;INTRAVENOUS | 021462-002 | Sep 7, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for pemetrexed disodium
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Denmark | 1313508 | Start Trial |
| Australia | 6968801 | Start Trial |
| Cyprus | 1107649 | Start Trial |
| Japan | 2014005304 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for pemetrexed disodium
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0432677 | 7/2005 | Austria | Start Trial | PRODUCT NAME: PEMETREXED UND DESSEN PHARMAZEUTISCH ANNAHMBAREN SALZE; REGISTRATION NO/DATE: EU/1/04/290/001 20040920 |
| 0432677 | SPC/GB05/011 | United Kingdom | Start Trial | PRODUCT NAME: PEMETREXED AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/290/001 20040920 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.