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THALOMID Drug Profile
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When do Thalomid patents expire, and when can generic versions of Thalomid launch?
Thalomid is a drug marketed by Celgene and is included in one NDA. There are nine patents protecting this drug and three Paragraph IV challenges.
This drug has forty-seven patent family members in nineteen countries.
The generic ingredient in THALOMID is thalidomide. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the thalidomide profile page.
US ANDA Litigation and Generic Entry Outlook for Thalomid
Thalomid was eligible for patent challenges on July 16, 2002.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 23, 2020. This may change due to patent challenges or generic licensing.
There have been twenty-two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for THALOMID
| International Patents: | 47 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 111 |
| Clinical Trials: | 71 |
| Patent Applications: | 6,985 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for THALOMID |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for THALOMID |
| DailyMed Link: | THALOMID at DailyMed |
Generic Entry Opportunity Date for THALOMID
Generic Entry Date for THALOMID*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
*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 THALOMID
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Nanfang Hospital of Southern Medical University | Phase 3 |
| Janssen, LP | Phase 2 |
| University of Miami | N/A |
Recent Litigation for THALOMID
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| CELGENE CORPORATION v. DR. REDDY'S LABORATORIES, LTD. | 2019-07-12 |
| CELGENE CORPORATION v. APOTEX INC. | 2019-06-19 |
| CELGENE CORPORATION v. APOTEX INC. | 2019-02-14 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| Coalition For Affordable Drugs VI LLC | 2015-04-23 |
Pharmacology for THALOMID
| Physiological Effect | Decreased Immunologically Active Molecule Activity |
Synonyms for THALOMID
| .alpha.-(N-Phthalimido)glutarimide |
| .alpha.-N-Phthalylglutaramide |
| .alpha.-Phthalimidoglutarimide |
| ( inverted question mark)-2-(2,6-Dioxo-3-piperidinyl)-1H-isoindole-1,3(2H)-dione |
| ( inverted question mark)-Thalidomide |
| (?)-Thalidomide |
| (.+/-.)-Thalidomide |
| (+-)-N-(2,6-Dioxo-3-piperidyl)phthalimide |
| (+-)-Thalidomide |
| (+/-)-2-(2,6-Dioxo-3-piperidinyl)-1H-isoindole-1,3(2H)-dione |
| (+/-)-N-(2,6-Dioxo-3-piperidinyl)phthalimide |
| (+/-)-N-(2,6-dioxo-3-piperidyl)phthalimide |
| (+/-)-THALIDOMIDE |
| (+/-)-Thalidomide, >=98%, powder |
| (A+/-)-Thalidomide |
| (y)-Thalidomide |
| [(R,S)-2-(2,6-dioxo-3-piperidinyl)-1H-isoindole-1,3(2H)-dione |
| 1,3-Dioxo-2-(2,6-dioxopiperidin-3-yl)isoindoline |
| 1012310-87-0 |
| 14088-68-7 |
| 153T873 |
| 1H-Isoindole-1, 2-(2,6-dioxo-3-piperidinyl)- |
| 1H-Isoindole-1, 2-(2,6-dioxo-3-piperidinyl)-, (R)- |
| 1H-Isoindole-1, 2-(2,6-dioxo-3-piperidinyl)-, (S)- |
| 1H-Isoindole-1,3(2H)-dione, 2-(2,6-dioxo-3-piperidinyl)- |
| 1H-Isoindole-1,3(2H)-dione, 2-(2,6-dioxo-3-piperidinyl)-, (+-)- |
| 2-(2,6-Dioxo-3-piperidinyl)-1H-isoindole-1,3(2H)-dione |
| 2-(2,6-Dioxo-3-piperidinyl)-1H-isoindole-1,3(2H)-dione # |
| 2-(2,6-dioxo-3-piperidyl)isoindoline-1,3-dione |
| 2-(2,6-Dioxo-piperidin-3-yl)-isoindole-1,3-dione |
| 2-(2,6-dioxoazaperhydroin-3-yl)benzo[c]azoline-1,3-dione |
| 2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione |
| 2-(2,6-dioxopiperidin-3-yl)-2,3-dihydro-1H-isoindole-1,3-dione |
| 2-(2,6-dioxopiperidin-3-yl)isoindole-1,3-dione |
| 2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione |
| 2-(6-hydroxy-2-oxo-2,3,4,5-tetrahydropyridin-3-yl)-2,3-dihydro-1H-isoindole-1,3-dione |
| 2,6-Dioxo-3-phthalimidopiperidine |
| 3-Phthalimidoglutarimide |
| 50-35-1 |
| 731-40-8 |
| AB00052362 |
| AB00052362_14 |
| AB00052362_15 |
| AB00052362-11 |
| AB00052362-12 |
| AB00052362-13 |
| AB0011813 |
| AB2000009 |
| AC-917 |
| AC1L1KBZ |
| AC1Q6FJA |
| AI3-50606 |
| AK-91024 |
| AKOS009529198 |
| Algosediv |
| alpha-(N-Phthalimido)glutarimide |
| alpha-N-Phthalylglutaramide |
| alpha-Phthalimidoglutarimide |
| AN-15419 |
| ANW-53225 |
| ARONIS24496 |
| AS-12367 |
| Asidon 3 |
| Asmadion |
| Asmaval |
| BBL023439 |
| BC204656 |
| BCP19772 |
| BDBM50070114 |
| Bio1_000387 |
| Bio1_000876 |
| Bio1_001365 |
| Bio2_000418 |
| Bio2_000898 |
| Bonbrain |
| Bonbrrin |
| BPBio1_000159 |
| BRD-A93255169-001-04-4 |
| BRD-A93255169-001-06-9 |
| BRD-A93255169-001-24-2 |
| BRN 0030233 |
| BSPBio_000143 |
| BSPBio_001156 |
| BSPBio_003330 |
| C07910 |
| C13H10N2O4 |
| Calmore |
| Calmorex |
| CAS-50-35-1 |
| CCG-39878 |
| CCRIS 8148 |
| Celgene |
| CHEBI:74947 |
| CHEMBL468 |
| cMAP_000022 |
| Contergan |
| Corronarobetin |
| CPD000058524 |
| CS-1084 |
| CTK8B6291 |
| D00754 |
| DB01041 |
| Distaval |
| Distaxal |
| Distoval |
| DivK1c_000051 |
| DSSTox_CID_2524 |
| DSSTox_GSID_22524 |
| DSSTox_RID_76611 |
| DTXSID9022524 |
| E-217 |
| Ectiluran |
| EINECS 200-031-1 |
| ENMD 0995 |
| Enterosediv |
| EU-0101224 |
| FT-0600001 |
| FT-0631211 |
| Gastrinide |
| Glupan |
| Glutanon |
| Glutarimide, 2-phthalimido- |
| Grippex |
| GTPL7327 |
| Hippuzon |
| HMS1362J17 |
| HMS1568H05 |
| HMS1792J17 |
| HMS1922E12 |
| HMS1990J17 |
| HMS2090O05 |
| HMS2093G15 |
| HMS2095H05 |
| HMS2234C07 |
| HMS3259C22 |
| HMS3263F10 |
| HMS3266F13 |
| HMS3373E06 |
| HMS3373G15 |
| HMS3403J17 |
| HMS3654A20 |
| HMS3712H05 |
| HMS500C13 |
| HSDB 3586 |
| HY-14658 |
| I06-0197 |
| I14-23643 |
| IDI1_000051 |
| IDI1_002173 |
| Imida-lab |
| Imidan (peyta) |
| Imidene |
| IN1061 |
| Isomin |
| J90042 |
| K 17 |
| K-17 |
| KB-61574 |
| KBio1_000051 |
| KBio2_000496 |
| KBio2_002322 |
| KBio2_003064 |
| KBio2_004890 |
| KBio2_005632 |
| KBio2_007458 |
| KBio3_000911 |
| KBio3_000912 |
| KBio3_002550 |
| KBio3_002802 |
| KBioGR_000496 |
| KBioGR_001474 |
| KBioGR_002322 |
| KBioSS_000496 |
| KBioSS_002324 |
| Kedavon |
| Kevadon |
| KS-00000H64 |
| Lopac0_001224 |
| LP01224 |
| LS-109463 |
| LS-140 |
| M-1523 |
| MCULE-6327754946 |
| MFCD00153873 |
| MLS000069353 |
| MolPort-003-665-582 |
| N-(2,6-dioxo-3-piperidinyl)phthalimide |
| N-(2,6-Dioxo-3-piperidyl)phthalimide |
| n-(2,6-dioxopiperidin-3-yl)phthalimide |
| N-Phthalimidoglutamic acid imide |
| N-Phthaloylglutamimide |
| N-Phthalyl-glutaminsaeure-imid |
| N-Phthalyl-glutaminsaeure-imid [German] |
| N-Phthalylglutamic acid imide |
| NC00600 |
| NCGC00015989-03 |
| NCGC00015989-04 |
| NCGC00015989-05 |
| NCGC00015989-06 |
| NCGC00015989-07 |
| NCGC00015989-08 |
| NCGC00015989-09 |
| NCGC00015989-10 |
| NCGC00015989-11 |
| NCGC00015989-12 |
| NCGC00015989-13 |
| NCGC00015989-14 |
| NCGC00015989-16 |
| NCGC00015989-17 |
| NCGC00024708-02 |
| NCGC00024708-03 |
| NCGC00024708-04 |
| NCGC00024708-05 |
| NCGC00024708-06 |
| NCGC00024708-07 |
| NCGC00024708-08 |
| NCGC00024708-09 |
| NCGC00024708-10 |
| NCGC00024708-11 |
| NCGC00254343-01 |
| NCGC00261909-01 |
| NCI60_023904 |
| NCIOpen2_003188 |
| Neaufatin |
| Neosedyn |
| Neosydyn |
| Nerosedyn |
| Neufatin |
| Neurodyn |
| Neurosedin |
| Neurosedym |
| Neurosedyn |
| Nevrodyn |
| Nibrol |
| NINDS_000051 |
| Noctosediv |
| Noxodyn |
| NSC 527179 |
| NSC-527179 |
| NSC-66847 |
| NSC-758479 |
| NSC-91729 |
| NSC-91730 |
| NSC527179 |
| NSC66847 |
| NSC758479 |
| NSC91729 |
| NSC91730 |
| Pangul |
| Pantosediv |
| Pharmakon1600-01503607 |
| Pharmion |
| Phthalimide, N-(2,6-dioxo-3-piperidyl)- |
| Phthalimide, N-(2,6-dioxo-3-piperidyl)-, (+-)- |
| Phthalimide,6-dioxo-3-piperidyl)- |
| Phthalimide,6-dioxo-3-piperidyl)-, (-)- |
| Phthalimide,6-dioxo-3-piperidyl)-, (+)- |
| Phthalimide,6-dioxo-3-piperidyl)-, D-(+)- |
| Phthalimide,6-dioxo-3-piperidyl)-, L-(-)- |
| Poly-Giron |
| Polygripan |
| Predni-Sediv |
| Prestwick_463 |
| Prestwick0_000192 |
| Prestwick1_000192 |
| Prestwick2_000192 |
| Prestwick3_000192 |
| Pro-Bam M |
| Pro-ban M |
| Profarmil |
| Psycholiquid |
| Psychotablets |
| Quetimid |
| Quietoplex |
| RP29207 |
| S1193 |
| SAM002564245 |
| Sandormin |
| SBI-0051191.P003 |
| SC-18573 |
| SCHEMBL15197560 |
| SCHEMBL7581 |
| Sedalis |
| Sedalis sedi-lab |
| Sedimide |
| Sedin |
| Sedisperil |
| Sedoval |
| Shin-naito S |
| Shinnibrol |
| Sleepan |
| Slipro |
| SMR000058524 |
| Softenil |
| Softenon |
| SPBio_000893 |
| SPBio_002064 |
| SPECTRUM1503607 |
| Spectrum2_000707 |
| Spectrum3_001715 |
| Spectrum4_001087 |
| Spectrum5_001791 |
| SR-01000076184 |
| SR-01000076184-1 |
| SR-01000076184-3 |
| SR-01000076184-5 |
| SR-01000076184-8 |
| ST24027458 |
| ST51039042 |
| STL356025 |
| SW196678-4 |
| Synovir |
| Talargan |
| Talidomida |
| Talidomida [INN-Spanish] |
| Talidomide |
| Talidomide [DCIT] |
| Talimol |
| Talinol |
| Talismol |
| Talizer |
| TC-141970 |
| Telagan |
| Telargan |
| Telargean |
| Tensival |
| Thaled |
| Thaled (TN) |
| thalidomide |
| Thalidomide (+ and -) |
| THALIDOMIDE (AIDS INITIATIVE) |
| Thalidomide (JAN/USP/INN) |
| Thalidomide (soluble form) |
| Thalidomide [USAN:INN:BAN] |
| Thalidomide [USAN:USP:INN:BAN:JAN] |
| Thalidomide Celgene |
| Thalidomide Pharmion |
| Thalidomide, United States Pharmacopeia (USP) Reference Standard |
| Thalidomide,(S) |
| Thalidomidum |
| Thalidomidum [INN-Latin] |
| Thalidomine USP26 |
| Thalin |
| Thalinette |
| Thalomid (TM) |
| Thalomid (TN) |
| Thalomid (TN) (Celgene) |
| Thalomide |
| Theophilcholine |
| Tox21_110275 |
| Tox21_110275_1 |
| Tox21_300580 |
| Tox21_501224 |
| UEJJHQNACJXSKW-UHFFFAOYSA-N |
| UPCMLD-DP139 |
| UPCMLD-DP139:001 |
| Valgis |
| Valgraine |
| W-105969 |
| WLN: T56 BVNVJ C- DT6VMVTJ |
| WLN: T56 BVNVJ C- DT6VMVTJ -D |
| WLN: T56 BVNVJ C- DT6VMVTJ -L |
| Yodomin |
| Z1550675451 |
Paragraph IV (Patent) Challenges for THALOMID
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| THALOMID | CAPSULE;ORAL | thalidomide | 020785 | 2014-02-03 |
| THALOMID | CAPSULE;ORAL | thalidomide | 020785 | 2006-12-18 |
US Patents and Regulatory Information for THALOMID
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-004 | Jan 10, 2007 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-003 | Jan 17, 2003 | RX | Yes | Yes | 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 |
Expired US Patents for THALOMID
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-004 | Jan 10, 2007 | Start Trial | Start Trial |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-002 | Jan 17, 2003 | Start Trial | Start Trial |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-004 | Jan 10, 2007 | Start Trial | Start Trial |
| Celgene | THALOMID | thalidomide | CAPSULE;ORAL | 020785-001 | Jul 16, 1998 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for THALOMID
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 1562556 | Start Trial |
| Australia | 780486 | Start Trial |
| Australia | 2005201675 | Start Trial |
| Japan | 4927905 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for THALOMID
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0688211 | 08C0036 | France | Start Trial | PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416 |
| 0688211 | SPC/GB08/039 | United Kingdom | Start Trial | PRODUCT NAME: THALIDOMIDE (INTERNATIONAL NON-PROPRIETARY NAME) 2-(2,6-DIOXOPIPERIDIN-3-YL) ISOINDOLINE-1,3-DIONE (SYSTEMATIC (IUPAC) NAME); REGISTERED: UK EU/1/08/443/001 20080416 |
| 0620232 | 08C0036 | France | Start Trial | PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416 |
| 0688211 | C300358 | Netherlands | Start Trial | PRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
