DrugPatentWatch Database Preview
IMBRUVICA Drug Profile
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When do Imbruvica patents expire, and when can generic versions of Imbruvica launch?
Imbruvica is a drug marketed by Pharmacyclics Inc and is included in two NDAs. There are twenty-seven patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in IMBRUVICA is ibrutinib. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.
Summary for IMBRUVICA
Generic Entry Opportunity Date for IMBRUVICA
Generic Entry Dates for IMBRUVICA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
Generic Entry Dates for IMBRUVICA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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.
Pharmacology for IMBRUVICA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Synonyms for IMBRUVICA
| (R)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one |
| (R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-ylprop-2-en-1-one |
| 1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one |
| 1-[(3R)-3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one |
| 1-[(3R)-3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]-2-propen-1-one |
| 1-[(3R)-3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one |
| 1-[(3R)-3-[4-Amino-3-(4-phenoxyphenyl)pyrazolo[3, 4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one |
| 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidyl]prop-2-en-1-one |
| 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one |
| 1-{(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl}prop-2-en-1-one |
| 1X70OSD4VX |
| 2-Propen-1-one, 1-((3R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo(3,4-d)pyrimidin-1-yl)-1-piperidinyl)- |
| 2-Propen-1-one, 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]- |
| 936563-96-1 |
| A1-01649 |
| AB0008168 |
| ABP000965 |
| AC-26942 |
| ACN-030256 |
| AJ-91306 |
| AK133084 |
| AKOS022185476 |
| AMX10219 |
| AN-1333 |
| AOB87789 |
| AX8254580 |
| BDBM50357312 |
| CHEBI:76612 |
| CHEMBL1873475 |
| CRA 032765 |
| CRA-032765 |
| D09KTS |
| D10223 |
| DB09053 |
| EBD2165770 |
| EX-5960 |
| EX-A066 |
| FT-0696693 |
| GTPL6912 |
| HSDB 8260 |
| HY-10997 |
| Ibrutinib |
| Ibrutinib (BTK inhibitor) |
| Ibrutinib (JAN/USAN) |
| Ibrutinib (PCI-32765) |
| Ibrutinib (PCI32765) |
| Ibrutinib [USAN:INN] |
| Ibrutinib(PCI-32765) |
| Ibrutinib/PCI-32765 |
| ibrutinibum |
| Imbruvica (TN) |
| J-523872 |
| JNJ 02 |
| KB-79777 |
| KIN0000174 |
| KS-000002KE |
| MFCD20261150 |
| MLS006010041 |
| MolPort-027-806-955 |
| NCGC00187912-01 |
| NCGC00187912-02 |
| NCGC00187912-03 |
| Pc-32765 |
| PCI 32765 |
| PCI-32765 |
| PCI-32765 (Ibrutinib) |
| PCI-32765-00 |
| PCI-32765(Ibrutinib) |
| PCI32765 |
| QC-4573 |
| S-7810 |
| SC-96633 |
| SCHEMBL201859 |
| SMR004701213 |
| UNII-1X70OSD4VX |
| X7513 |
| XYFPWWZEPKGCCK-GOSISDBHSA-N |
| ZINC35328014 |
US Patents and Regulatory Information for IMBRUVICA
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Paragraph IV (Patent) Challenges for IMBRUVICA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Capsules | 140 mg | ➤ Subscribe | ➤ Try a Free Trial |
Non-Orange Book US Patents for IMBRUVICA
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 |
|---|---|---|
| 8,501,751 | Inhibitors of Bruton's tyrosine kinase | ➤ Try a Free Trial |
| 8,748,439 | Inhibitors of Bruton's tyrosine kinase | ➤ Try a Free Trial |
| 8,552,010 | Inhibitors of Bruton'S tyrosine kinase | ➤ Try a Free Trial |
| 9,181,263 | Inhibitors of bruton's tyrosine kinase | ➤ Try a Free Trial |
| 8,741,908 | Inhibitors of bruton's tyrosine kinase | ➤ Try a Free Trial |
| 9,193,735 | Inhibitors of Bruton's tyrosine kinase | ➤ Try a Free Trial |
| 10,004,745 | Use of inhibitors of Bruton'S tyrosine kinase (Btk) | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for IMBRUVICA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Poland | 2526771 | ➤ Try a Free Trial |
| Colombia | 7240408 | ➤ Try a Free Trial |
| European Patent Office | 2543375 | ➤ Try a Free Trial |
| South Africa | 201207075 | ➤ Try a Free Trial |
| Luxembourg | 93321 | ➤ Try a Free Trial |
| Hungary | S1700012 | ➤ Try a Free Trial |
| Canada | 2991994 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for IMBRUVICA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 321 | Luxembourg | ➤ Try a Free Trial | PRODUCT NAME: INHIBITEURS DE LA TYROSINE KINASE DE BRUTON |
| 2015017,C2201840 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
| 0728 | Netherlands | ➤ Try a Free Trial | DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), SAMENVOEGEN |
| 3 5006-2015 | Slovakia | ➤ Try a Free Trial | PRODUCT NAME: IBRUTINIB; REGISTRATION NO/DATE: EU/1/14/945 20141023 |
| 2016034 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: IBRUTINIBAS ARBA FARMACISKAI PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2016)3293 20160526 |
| /2015 | Austria | ➤ Try a Free Trial | PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
| 2017009 | Lithuania | ➤ Try a Free Trial | PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
