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VERZENIO Drug Profile
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When do Verzenio patents expire, and what generic alternatives are available?
Verzenio is a drug marketed by Eli Lilly And Co and is included in one NDA. There is one patent protecting this drug.
This drug has forty-six patent family members in forty-two countries.
The generic ingredient in VERZENIO is abemaciclib. One supplier is listed for this compound. Additional details are available on the abemaciclib profile page.
US ANDA Litigation and Generic Entry Outlook for Verzenio
Verzenio will be eligible for patent challenges on September 28th, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 15th, 2029. This may change due to patent challenges or generic licensing.
Summary for VERZENIO
| International Patents: | 46 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 61 |
| Clinical Trials: | 11 |
| Patent Applications: | 34 |
| Drug Prices: | Drug price information for VERZENIO |
| DailyMed Link: | VERZENIO at DailyMed |
Generic Entry Opportunity Date for VERZENIO
Generic Entry Date for VERZENIO*:
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.
Recent Clinical Trials for VERZENIO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 1/Phase 2 |
| University of Texas Southwestern Medical Center | Phase 2 |
| National Cancer Institute (NCI) | Early Phase 1 |
Pharmacology for VERZENIO
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Kinase Inhibitors |
Synonyms for VERZENIO
| [5-(4-ethyl-piperazin-1-ylmethyl)-pyridin-2-yl]-[5-fluoro-4-(7-fluoro-3-isopropyl-2-methyl-3H-benzoimidazol-5-yl)-pyrimidin-2-yl]-amine |
| 1231929-97-7 |
| 2-Pyrimidinamine, N-(5-((4-ethyl-1-piperazinyl)methyl)-2-pyridinyl)-5-fluoro-4-(4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl) |
| 2-Pyrimidinamine,N-[5-[(4-ethyl-1-piperazinyl)methyl]-2-pyridinyl]-5-fluoro-4-[4-fluoro-2-methyl-1-(1-methylethyl)-1H-benzimidazol-6-yl]- |
| 3798AH |
| 60UAB198HK |
| 6ZV |
| Abemaciclib |
| Abemaciclib (JAN/USAN) |
| Abemaciclib (ly2835219) |
| Abemaciclib [USAN:INN] |
| Abemaciclib,LY2835219 |
| AK174895 |
| AKOS025404907 |
| AS-10230 |
| AX8323622 |
| BCP13079 |
| BDBM50110183 |
| bemaciclib |
| C27H32F2N8 |
| CHEMBL3301610 |
| CS-1230 |
| D10688 |
| DB12001 |
| DTXSID20673119 |
| EX-A1588 |
| EX-A521 |
| FT-0700134 |
| GTPL7382 |
| HY-16297A |
| J-690083 |
| KB-69638 |
| KS-00000T51 |
| LY 2835219 |
| LY 2835219 (free base) |
| LY-2835219 |
| LY-2835219|||N-[5-[(4-Ethylpiperazin-1-yl)methyl]pyridin-2-yl]-5-fluoro-4-(7-fluoro-2-methyl-3-propan-2-ylbenzimidazol-5-yl)pyrimidin-2-amine |
| LY2835219 |
| LY2835219 (free base) |
| LY2835219 free base |
| LY2835219 free base (Abemaciclib) |
| LY2835219 Ms salt, Abemaciclib Ms salt |
| MolPort-039-137-732 |
| N-(5-((4-ethylpiperazin-1-yl)methyl)pyridin-2-yl)-5-fluoro-4-(4-fluoro-1-isopropyl-2-methyl-1H-benzo[d]imidazol-6-yl)pyrimidin-2-amine |
| N-[5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-yl]-5-fluoro-4-(7-fluoro-2-methyl-3-propan-2-ylbenzimidazol-5-yl)pyrimidin-2-amine |
| N-{5-[(4-ethylpiperazin-1-yl)methyl]pyridin-2-yl}-5-fluoro-4-(7-fluoro-3-isopropyl-2-methyl-1,3-benzodiazol-5-yl)pyrimidin-2-amine |
| N-{5-[(4-Ethylpiperazin-1-yl)methyl]pyridin-2-yl}-5-fluoro-4-[4-fluoro-2-methyl-1-(propan-2-yl)-1H-benzimidazol-6-yl]pyrimidin-2-amine |
| NCGC00351599-06 |
| QC-11713 |
| SB16476 |
| SC-82423 |
| SCHEMBL2487229 |
| Tube014 |
| UNII-60UAB198HK |
| UZWDCWONPYILKI-UHFFFAOYSA-N |
| Verzenio (TN) |
| Verzenios |
| W-5974 |
| ZINC72318121 |
US Patents and Regulatory Information for VERZENIO
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eli Lilly And Co | VERZENIO | abemaciclib | TABLET;ORAL | 208716-001 | Sep 28, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Eli Lilly And Co | VERZENIO | abemaciclib | TABLET;ORAL | 208716-001 | Sep 28, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Eli Lilly And Co | VERZENIO | abemaciclib | TABLET;ORAL | 208716-004 | Sep 28, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Eli Lilly And Co | VERZENIO | abemaciclib | TABLET;ORAL | 208716-004 | Sep 28, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for VERZENIO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Taiwan | I429635 | Start Trial |
| Eurasian Patent Organization | 018808 | Start Trial |
| Honduras | 2011001701 | Start Trial |
| Malaysia | 150547 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VERZENIO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2379528 | 300969 | Netherlands | Start Trial | PRODUCT NAME: ABEMACICLIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/18/1307 20181001 |
| 2379528 | 1990013-3 | Sweden | Start Trial | PRODUCT NAME: ABEMACICLIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/18/1307 20181001 |
| 2379528 | C20190008 00271 | Estonia | Start Trial | PRODUCT NAME: ABEMATSIKLIIB;REG NO/DATE: EU/1/18/1307 01.10.2018 |
| 2379528 | CR 2019 00008 | Denmark | Start Trial | PRODUCT NAME: ABEMACICLIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/18/1307 20181001 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
