LAPATINIB DITOSYLATE Drug Patent Profile
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Which patents cover Lapatinib Ditosylate, and when can generic versions of Lapatinib Ditosylate launch?
Lapatinib Ditosylate is a drug marketed by Natco Pharma Ltd and is included in one NDA.
The generic ingredient in LAPATINIB DITOSYLATE is lapatinib ditosylate. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the lapatinib ditosylate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lapatinib Ditosylate
A generic version of LAPATINIB DITOSYLATE was approved as lapatinib ditosylate by NATCO PHARMA LTD on September 29th, 2020.
Summary for LAPATINIB DITOSYLATE
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 238 |
| Clinical Trials: | 67 |
| Patent Applications: | 3,263 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | LAPATINIB DITOSYLATE at DailyMed |
Recent Clinical Trials for LAPATINIB DITOSYLATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Stanford University | Phase 2 |
| Jonsson Comprehensive Cancer Center | Phase 1/Phase 2 |
| Washington University School of Medicine | Phase 2 |
Pharmacology for LAPATINIB DITOSYLATE
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for LAPATINIB DITOSYLATE
Paragraph IV (Patent) Challenges for LAPATINIB DITOSYLATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TYKERB | Tablets | lapatinib ditosylate | 250 mg | 022059 | 1 | 2011-03-14 |
US Patents and Regulatory Information for LAPATINIB DITOSYLATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Natco Pharma Ltd | LAPATINIB DITOSYLATE | lapatinib ditosylate | TABLET;ORAL | 203007-001 | Sep 29, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
