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NERLYNX Drug Profile
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» See Plans and PricingWhich patents cover Nerlynx, and what generic alternatives are available?
Nerlynx is a drug marketed by Puma Biotech and is included in one NDA. There are eight patents protecting this drug.
This drug has one hundred and eighteen patent family members in twenty-nine countries.
The generic ingredient in NERLYNX is neratinib maleate. One supplier is listed for this compound. Additional details are available on the neratinib maleate profile page.
US ANDA Litigation and Generic Entry Outlook for Nerlynx
Nerlynx will be eligible for patent challenges on July 17, 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 29, 2025. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for NERLYNX
| International Patents: | 118 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 83 |
| Clinical Trials: | 4 |
| Patent Applications: | 131 |
| Drug Prices: | Drug price information for NERLYNX |
| DailyMed Link: | NERLYNX at DailyMed |
Generic Entry Opportunity Date for NERLYNX
Generic Entry Date for NERLYNX*:
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 NERLYNX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Puma Biotechnology, Inc. | Phase 1/Phase 2 |
| Virginia Commonwealth University | Phase 1/Phase 2 |
| NSABP Foundation Inc | Phase 2 |
Pharmacology for NERLYNX
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Kinase Inhibitors P-Glycoprotein Inhibitors |
US Patents and Regulatory Information for NERLYNX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | RX | Yes | Yes | Start Trial | Start Trial | 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 |
Expired US Patents for NERLYNX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Puma Biotech | NERLYNX | neratinib maleate | TABLET;ORAL | 208051-001 | Jul 17, 2017 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NERLYNX
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Brazil | PI1012699 | Start Trial |
| Argentina | 078952 | Start Trial |
| China | 106822127 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
