DrugPatentWatch Database Preview
LORBRENA Drug Profile
» See Plans and Pricing
When do Lorbrena patents expire, and what generic alternatives are available?
Lorbrena is a drug marketed by Pfizer Inc and is included in one NDA. There are two patents protecting this drug.
This drug has seventy-one patent family members in forty-five countries.
The generic ingredient in LORBRENA is lorlatinib. One supplier is listed for this compound. Additional details are available on the lorlatinib profile page.
US ANDA Litigation and Generic Entry Outlook for Lorbrena
Lorbrena will be eligible for patent challenges on November 2, 2022. 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 July 27, 2036. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for LORBRENA
| International Patents: | 71 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 47 |
| Clinical Trials: | 1 |
| Patent Applications: | 41 |
| Drug Prices: | Drug price information for LORBRENA |
| DailyMed Link: | LORBRENA at DailyMed |
Generic Entry Opportunity Date for LORBRENA
Generic Entry Date for LORBRENA*:
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 LORBRENA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Massachusetts General Hospital | Phase 1/Phase 2 |
| Array BioPharma | Phase 1/Phase 2 |
| Pfizer | Phase 1/Phase 2 |
Pharmacology for LORBRENA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Kinase Inhibitors Cytochrome P450 3A4 Inducers |
US Patents and Regulatory Information for LORBRENA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer Inc | LORBRENA | lorlatinib | TABLET;ORAL | 210868-001 | Nov 2, 2018 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Pfizer Inc | LORBRENA | lorlatinib | TABLET;ORAL | 210868-002 | Nov 2, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Pfizer Inc | LORBRENA | lorlatinib | TABLET;ORAL | 210868-001 | Nov 2, 2018 | 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 |
International Patents for LORBRENA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Eurasian Patent Organization | 026155 | Start Trial |
| Cyprus | 1118771 | Start Trial |
| Georgia, Republic of | P201606560 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LORBRENA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2822953 | 301006 | Netherlands | Start Trial | PRODUCT NAME: LORLATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/19/1355 20190508 |
| 2822953 | LUC00131 | Luxembourg | Start Trial | PRODUCT NAME: LORVIQUA - IORLATINIB; AUTHORISATION NUMBER AND DATE: EU/1/19/1355 20190508 |
| 2822953 | 122019000088 | Germany | Start Trial | PRODUCT NAME: LORLATINIB ODER PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/19/1355 20190506 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
