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Pomalidomide - Generic Drug Details
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What are the generic drug sources for pomalidomide and what is the scope of patent protection?
Pomalidomide
is the generic ingredient in one branded drug marketed by Celgene and is included in one NDA. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Pomalidomide has three hundred and seventy patent family members in forty-six countries.
There are eleven drug master file entries for pomalidomide. One supplier is listed for this compound.
Summary for pomalidomide
| International Patents: | 370 |
| US Patents: | 10 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 11 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 103 |
| Clinical Trials: | 161 |
| Patent Applications: | 480 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for pomalidomide |
| DailyMed Link: | pomalidomide at DailyMed |
Recent Clinical Trials for pomalidomide
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Bristol-Myers Squibb | Phase 1/Phase 2 |
| The Cleveland Clinic | Phase 2 |
| Multiple Myeloma Research Consortium | Phase 1/Phase 2 |
Recent Litigation for pomalidomide
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Celgene Corporation v. Hetero Labs Limited | 2019-08-23 |
| CELGENE CORPORATION v. DR. REDDY'S LABORATORIES, LTD. | 2019-07-12 |
| CELGENE CORPORATION v. APOTEX INC. | 2019-06-19 |
See all pomalidomide litigation
PTAB Litigation
| Petitioner | Date |
|---|---|
| Coalition for Affordable Drugs VI LLC | 2015-05-07 |
| Coalition For Affordable Drugs VI LLC | 2015-04-23 |
Pharmacology for pomalidomide
| Drug Class | Thalidomide Analog |
Synonyms for pomalidomide
| 1,3-dioxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline |
| 171P198 |
| 19171-19-8 |
| 1H-Isoindole-1,3(2H)-dione, 4-amino-2-(2,6-dioxo-3-piperidinyl)- |
| 3-amino-N-(2,6-dioxo-3-piperidyl)phthalamide |
| 3-Amino-N-(2,6-dioxo-3-piperidyl)phthalimide |
| 3-Aminophthalimidoglutarimide |
| 4-amino-2-(2,6-dioxo-3-piperidinyl)-1H-Isoindole-1,3(2H)-dione |
| 4-Amino-2-(2,6-dioxo-3-piperidinyl)isoindole-1,3-dione |
| 4-Amino-2-(2,6-dioxo-3-piperidyl) isoindoline -1,3-dione |
| 4-Amino-2-(2,6-dioxo-3-piperidyl)isoindoline-1,3-dione |
| 4-AMINO-2-(2,6-DIOXO-PIPERIDIN-3-YL)ISOINDOLE-1,3-DIONE |
| 4-amino-2-(2,6-dioxo(3-piperidyl))isoindoline-1,3-dione |
| 4-amino-2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione |
| 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindole-1,3-dione |
| 4-amino-2-(2,6-dioxopiperidin-3-yl)isoindoline-1,3-dione |
| 4-Aminothalidomide |
| 443912-23-0 |
| 443919-33-3 |
| 4CH-001846 |
| AB0021203 |
| AB01565777_02 |
| AC-26970 |
| AC1L358B |
| AC1Q6NYN |
| ACN-034796 |
| Actimid |
| Actimid|||CC 4047|||IMiD3 |
| AK104087 |
| AKOS013400288 |
| ANW-69609 |
| AS-17905 |
| AX8235626 |
| BC213119 |
| BCP02890 |
| BCP0726000263 |
| BCP09107 |
| BDBM65456 |
| CC 4047 |
| CC-4047 |
| CC-4047, Actimid, 19171-19-8 |
| CDC-394 |
| CHEBI:72690 |
| CHEMBL43452 |
| CS-0165 |
| CTK4I8155 |
| D08976 |
| DB08910 |
| EBD24712 |
| FT-0697903 |
| GTPL7348 |
| HMS3655G05 |
| HSDB 8222 |
| HY-10984 |
| IMiD 3 |
| IMID-3 |
| IMID-4047 |
| IMiD1 |
| Imnovid |
| J-012392 |
| J-514302 |
| KB-239921 |
| KB-239922 |
| KB-71997 |
| Lipopolysaccharides from Escherichia coli 055:B5 pound>>Lipopolysaccharides pound>> lipoglycans pound>>endotoxins |
| LS40023 |
| MFCD12756407 (97%) |
| MLS006011261 |
| MolPort-016-633-239 |
| NCGC00346551-01 |
| P2074 |
| Phthalimide, 3-amino-N-(2,6-dioxo-3-piperidyl)- |
| Pomalidomide (CC-4047) |
| Pomalidomide (JAN/USAN/INN) |
| Pomalidomide [USAN:INN] |
| Pomalidomide, >=98% (HPLC) |
| Pomalyst |
| Pomalyst (TN) |
| PubChem22200 |
| RL02421 |
| s1567 |
| SB16552 |
| SCHEMBL19250920 |
| SCHEMBL369172 |
| SMR004703012 |
| SR-01000941573 |
| SR-01000941573-1 |
| ST24023268 |
| SW218099-2 |
| SY054807 |
| TC-158354 |
| UVSMNLNDYGZFPF-UHFFFAOYSA-N |
| V2447 |
| W-5536 |
Paragraph IV (Patent) Challenges for POMALIDOMIDE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| POMALYST | CAPSULE;ORAL | pomalidomide | 204026 | 2017-02-08 |
US Patents and Regulatory Information for pomalidomide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-001 | Feb 8, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-002 | Feb 8, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-002 | Feb 8, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-001 | Feb 8, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-003 | Feb 8, 2013 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-002 | Feb 8, 2013 | 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 |
Expired US Patents for pomalidomide
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-004 | Feb 8, 2013 | Start Trial | Start Trial |
| Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-004 | Feb 8, 2013 | Start Trial | Start Trial |
| Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-001 | Feb 8, 2013 | Start Trial | Start Trial |
| Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-002 | Feb 8, 2013 | Start Trial | Start Trial |
| Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-004 | Feb 8, 2013 | Start Trial | Start Trial |
| Celgene | POMALYST | pomalidomide | CAPSULE;ORAL | 204026-003 | Feb 8, 2013 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for pomalidomide
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 100923173 | Start Trial |
| Denmark | 3045176 | Start Trial |
| Japan | 2005530784 | Start Trial |
| Norway | 336898 | Start Trial |
| Luxembourg | 92642 | Start Trial |
| Slovenia | 3351240 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for pomalidomide
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2105135 | CA 2015 00006 | Denmark | Start Trial | PRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805 |
| 2105135 | 92642 | Luxembourg | Start Trial | PRODUCT NAME: POMALIDOMIDE ET SES SELS, SOLVATES, HYDRATES OU STEREOISOMERES PHARMACEUTIQUEMENT ACCEPTABLES QUI EN DERIVENT (IMNOVID); FIRST REGISTRATION DATE: 20130805 |
| 2105135 | 00140 | Estonia | Start Trial | |
| 2105135 | 122015000013 | Germany | Start Trial | PRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805 |
| 2105135 | C20150005 00140 | Estonia | Start Trial | PRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013 |
| 2105135 | 212 50002-2015 | Slovakia | Start Trial | PRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2019 - 2020
NCE-1 Patent Challenge Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.