SUNITINIB MALATE Drug Patent Profile
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When do Sunitinib Malate patents expire, and when can generic versions of Sunitinib Malate launch?
Sunitinib Malate is a drug marketed by Dr Reddys, Mylan, Natco Pharma, Novugen, Sun Pharm, and Teva Pharms Usa. and is included in six NDAs.
The generic ingredient in SUNITINIB MALATE is sunitinib malate. There are eight drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the sunitinib malate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Sunitinib Malate
A generic version of SUNITINIB MALATE was approved as sunitinib malate by SUN PHARM on August 16th, 2021.
Summary for SUNITINIB MALATE
US Patents: | 0 |
Applicants: | 6 |
NDAs: | 6 |
Finished Product Suppliers / Packagers: | 7 |
Raw Ingredient (Bulk) Api Vendors: | 81 |
Clinical Trials: | 175 |
Patent Applications: | 1,484 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for SUNITINIB MALATE |
DailyMed Link: | SUNITINIB MALATE at DailyMed |
Recent Clinical Trials for SUNITINIB MALATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Exelixis | Phase 3 |
VU University Medical Center | Phase 2/Phase 3 |
Graybug Vision | Phase 2 |
Pharmacology for SUNITINIB MALATE
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for SUNITINIB MALATE
Paragraph IV (Patent) Challenges for SUNITINIB MALATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
SUTENT | Capsules | sunitinib malate | 12.5 mg, 25 mg, 37.5 mg and 50 mg | 021938 | 1 | 2010-01-26 |
US Patents and Regulatory Information for SUNITINIB MALATE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dr Reddys | SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 215843-001 | Apr 11, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Sun Pharm | SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 213914-002 | Aug 16, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Teva Pharms Usa | SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 213803-004 | Nov 30, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan | SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 201275-003 | Dec 6, 2021 | 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 |