DrugPatentWatch Database Preview
INLYTA Drug Profile
When do Inlyta patents expire, and when can generic versions of Inlyta launch?
Inlyta is a drug marketed by Pf Prism Cv and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
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
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 84 |
| Clinical Trials: | 23 |
| Patent Applications: | 118 |
| Drug Prices: | Drug price information for INLYTA |
| 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 | |||
| Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-002 | Jan 27, 2012 | RX | Yes | Yes | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Pf Prism Cv | INLYTA | axitinib | TABLET;ORAL | 202324-002 | Jan 27, 2012 | RX | Yes | Yes | ➤ 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 |
Paragraph IV (Patent) Challenges for INLYTA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Tablets | 1 mg and 5 mg | ➤ Subscribe | ➤ Sign Up |
International Patents for INLYTA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Slovakia | 286936 | ➤ Sign Up |
| Tunisia | SN00146 | ➤ Sign Up |
| Argentina | 065937 | ➤ Sign Up |
| Israel | 201320 | ➤ Sign Up |
| Croatia | P20020109 | ➤ Sign Up |
| Slovenia | 1218348 | ➤ Sign Up |
| Argentina | 035554 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for INLYTA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 2013 00010 | Denmark | ➤ Sign Up | |
| 2013003 | Lithuania | ➤ Sign Up | PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903 |
| C0010 | France | ➤ Sign Up | PRODUCT NAME: AXITINIB, ET OPTIONNELLEMENT SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/777/001 20120903 |
| 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 |
| 00576 | Netherlands | ➤ Sign Up | PRODUCT NAME: AXITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/12/777/001-006 20120903 |
| 1218348/01 | Switzerland | ➤ Sign Up | FORMER OWNER: AGOURON PHARMACEUTICALS, INC., US |
| 2013003,C1218348 | Lithuania | ➤ Sign Up | PRODUCT NAME: AXITINIBUM; REGISTRATION NO/DATE: EU/1/12/777/001 - EU/1/12/777/006 20120903 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
