Details for New Drug Application (NDA): 207981
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NDA 207981 describes LONSURF, which is a drug marketed by Taiho Oncology and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the LONSURF profile page.
The generic ingredient in LONSURF is tipiracil hydrochloride; trifluridine. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tipiracil hydrochloride; trifluridine profile page.
The generic ingredient in LONSURF is tipiracil hydrochloride; trifluridine. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the tipiracil hydrochloride; trifluridine profile page.
Summary for 207981
| Tradename: | LONSURF |
| Applicant: | Taiho Oncology |
| Ingredient: | tipiracil hydrochloride; trifluridine |
| Patents: | 6 |
Pharmacology for NDA: 207981
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors Thymidine Phosphorylase Inhibitors |
Suppliers and Packaging for NDA: 207981
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981 | NDA | Taiho Pharmaceutical Co., Ltd. | 64842-1020 | 64842-1020-1 | 20 TABLET, FILM COATED in 1 BOTTLE (64842-1020-1) |
| LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981 | NDA | Taiho Pharmaceutical Co., Ltd. | 64842-1020 | 64842-1020-2 | 40 TABLET, FILM COATED in 1 BOTTLE (64842-1020-2) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 6.14MG BASE;15MG | ||||
| Approval Date: | Sep 22, 2015 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Feb 22, 2026 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF ADULT PATIENTS WITH METASTATIC GASTRIC OR GASTROESOPHAGEAL JUNCTION ADENOCARCINOMA PREVIOUSLY TREATED WITH AT LEAST TWO PRIOR LINES OF CHEMOTHERAPY, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 3, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF METASTATIC COLORECTAL CANCER ALONE OR WITH BEVACIZUMAB IN SEVERELY RENALLY IMPAIRED PATIENTS PREVIOUSLY TREATED WITH FLUOROPYRIMIDINE-, OXALIPLATIN- AND IRINOTECAN THERAPY, AN ANTI-VEGF BIOLOGIC, AND IF RAS WILD-TYPE, ANTI-EGFR THERAPY | ||||||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 3, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF METASTATIC GASTRIC OR GJA IN SEVERELY RENALLY IMPAIRED PATIENTS TREATED WITH AT LEAST TWO LINES OF CHEMOTHERAPY THAT INCLUDED A FLUOROPYRIMIDINE, A PLATINUM, A TAXANE OR IRINOTECAN, AND IF APPROPRIATE, HER2/NEU-TARGETED THERAPY | ||||||||
Expired US Patents for NDA 207981
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-001 | Sep 22, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-002 | Sep 22, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| Taiho Oncology | LONSURF | tipiracil hydrochloride; trifluridine | TABLET;ORAL | 207981-001 | Sep 22, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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