Details for New Drug Application (NDA): 208051
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NDA 208051 describes NERLYNX, which is a drug marketed by Puma Biotech and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the NERLYNX profile page.
The generic ingredient in NERLYNX is neratinib maleate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the neratinib maleate profile page.
The generic ingredient in NERLYNX is neratinib maleate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the neratinib maleate profile page.
Summary for 208051
| Tradename: | NERLYNX |
| Applicant: | Puma Biotech |
| Ingredient: | neratinib maleate |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208051
Generic Entry Date for 208051*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 208051
| Mechanism of Action | Kinase Inhibitors P-Glycoprotein Inhibitors |
Suppliers and Packaging for NDA: 208051
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NERLYNX | neratinib maleate | TABLET;ORAL | 208051 | NDA | Puma Biotechnology, Inc. | 70437-240 | 70437-240-18 | 1 BOTTLE in 1 BOX (70437-240-18) / 180 TABLET in 1 BOTTLE |
| NERLYNX | neratinib maleate | TABLET;ORAL | 208051 | NDA | Puma Biotechnology, Inc. | 70437-240 | 70437-240-26 | 1 BOTTLE in 1 BOX (70437-240-26) / 126 TABLET in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 40MG BASE | ||||
| Approval Date: | Jul 17, 2017 | TE: | RLD: | Yes | |||||
| Patent: | 10,035,788 | Patent Expiration: | Oct 15, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY STAGE HER2-OVEREXPRESSED/AMPLIFIED BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASE THERAPY | ||||||||
| Patent: | 10,035,788 | Patent Expiration: | Oct 15, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | EXTENDED ADJUVANT TREATMENT OF ADULT PATIENTS WITH EARLY-STAGE HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2)-POSITIVE BREAST CANCER, TO FOLLOW ADJUVANT TRASTUZUMAB BASED THERAPY | ||||||||
| Patent: | 10,035,788 | Patent Expiration: | Oct 15, 2028 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE IN COMBINATION WITH CAPECITABINE, FOR THE TREATMENT OF ADULT PATIENTS WITH ADVANCED OR METASTATIC HER2-POSITIVE BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR ANTI-HER2 BASED REGIMENS IN THE METASTATIC SETTING | ||||||||
Expired US Patents for NDA 208051
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | 7,982,043 | ⤷ Start Trial |
| Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | 6,288,082 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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