DrugPatentWatch Database Preview
INLYTA Drug Profile
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Which patents cover Inlyta, and when can generic versions of Inlyta launch?
This drug has one hundred and nine patent family members in fifty-three countries.
The generic ingredient in INLYTA is axitinib. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the axitinib profile page.
Summary for INLYTA
| International Patents: | 109 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 88 |
| Clinical Trials: | 23 |
| Patent Applications: | 118 |
| DailyMed Link: | INLYTA at DailyMed |
Generic Entry Opportunity Date for INLYTA
*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 INLYTA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Receptor Tyrosine Kinase Inhibitors |
Synonyms for INLYTA
| (E)-N-Methyl-2-((3-(2-(pyridin-2-yl)vinyl)-1H-indazol-6-yl)thio)benzamide |
| (E)-N-methyl-2-(3-(2-(pyridin-2-yl)vinyl)-1H-indazol-6-ylthio)benzamide |
| 319460-85-0 |
| 460A850 |
| 4ag8 |
| 4agc |
| 4CA-0215 |
| 790713-39-2 |
| AB0008632 |
| AB01274739_02 |
| AB01274739-01 |
| ABP000115 |
| AC-1539 |
| AC1O51X3 |
| AG 013736 |
| AG-013736 |
| AG-013736, Axitinib |
| AG-013736;Axitinib |
| AG-13736 |
| AG013736 |
| AG13736 |
| AJ-45709 |
| AK106979 |
| AKOS015902898 |
| AM20090673 |
| AN-501 |
| AOB87786 |
| Axitinib |
| Axitinib (AG 013736) |
| Axitinib (JAN/USAN) |
| Axitinib (VEGFR inhibitor) |
| Axitinib [USAN:INN:JAN] |
| Axitinib, >=98% (HPLC) |
| Axitinib,AG-013736 |
| Axitinib/AG013736 |
| Axitinib|319460-85-0|AG 013736|AG013736 |
| axitinibum |
| BC659937 |
| BCP9000345 |
| BCPP000372 |
| BDBM25117 |
| Benzamide, N-methyl-2-((3-((1E)-2-(2-pyridinyl)ethenyl)-1H-indazo)-6-yl)thio)- |
| BRD-K29905972-001-01-4 |
| C22H18N4OS |
| C9LVQ0YUXG |
| CAS-319460-85-0 |
| cc-356 |
| CHEBI:66910 |
| CHEBI:94568 |
| CHEMBL1289926 |
| CJ-10777 |
| CS-0116 |
| D01ZRI |
| D03218 |
| DB06626 |
| DSSTox_CID_28975 |
| DSSTox_GSID_49049 |
| DSSTox_RID_83240 |
| DTXSID3049049 |
| EX-A337 |
| GTPL5659 |
| HE066076 |
| HE334772 |
| HY-10065 |
| I14-1971 |
| Inlyta (TN) |
| J-502064 |
| KB-02558 |
| KB-74537 |
| KS-1448 |
| MFCD09837898 |
| MLS006010164 |
| MolPort-006-392-413 |
| N-Methyl-[[3[(1E)-2-(2-pyridinyl)ethenyl]-1H-indazol-6-yl]thio]-benzamide |
| N-methyl-2-((3-((1E)-2-(pyridin-2-yl)ethenyl)-1H-indazol-6-yl)sulfanyl)benzamide |
| N-methyl-2-({3-[(E)-2-(pyridin-2-yl)ethenyl]-1H-indazol-6-yl}sulfanyl)benzamide |
| N-methyl-2-({3-[(E)-2-(pyridin-2-yl)vinyl]-1H-indazol-6-yl}sulfanyl)benzamide |
| N-methyl-2-[[3-[(E)-2-(2-pyridyl)vinyl]-1H-indazol-6-yl]sulfanyl]benzamide |
| N-methyl-2-[[3-[(E)-2-pyridin-2-ylethenyl]-1H-indazol-6-yl]sulfanyl]benzamide |
| NCGC00241108-01 |
| NCGC00241108-04 |
| NSC-757441 |
| NSC757441 |
| Q-200662 |
| Q-3279 |
| QCR-109 |
| RL03128 |
| S1005 |
| SC-22491 |
| SCHEMBL172918 |
| SMR002530046 |
| SR-01000941566 |
| SR-01000941566-1 |
| ST51054130 |
| SYN1014 |
| Tox21_113597 |
| Tox21_113597_1 |
| TR-013491 |
| UNII-C9LVQ0YUXG |
| ZINC3816287 |
US Patents and Regulatory Information for INLYTA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-001 | Jan 27, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-002 | Jan 27, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-001 | Jan 27, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-001 | Jan 27, 2012 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | ➤ 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 INLYTA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 1 mg and 5 mg | ➤ Subscribe | ➤ Sign Up |
Non-Orange Book US Patents for INLYTA
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 |
|---|---|---|
| 6,531,491 | Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use | ➤ Sign Up |
| 6,891,044 | Indazole compounds and pharmaceutical compositions for Inhibiting protein kinases, and methods for their use | ➤ Sign Up |
| 7,141,587 | Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use | ➤ Sign Up |
| 6,884,890 | Indazole compounds and pharmaceutical compositions for inhibiting protein kinases, and methods for their use | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for INLYTA
Supplementary Protection Certificates for INLYTA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2013003 | Lithuania | ➤ Sign Up | PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903 |
| 8 | Finland | ➤ Sign Up | |
| 90007-1 | Sweden | ➤ Sign Up | PRODUCT NAME: AXITINIB, VALFRITT I FORM AV ETT FARMACEUTISKT GODTAGBART SALT; REG. NO/DATE: EU/1/12/777/001 20120903 |
| 13/008 | Ireland | ➤ Sign Up | PRODUCT NAME: AXITINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/12/777/001 EU/1/12/777/006 20120903 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
