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, Eugia Pharma, Mylan, Natco Pharma, Sun Pharm, Teva Pharms Usa, and Wanbang Biopharms. and is included in seven NDAs.
The generic ingredient in SUNITINIB MALATE is sunitinib malate. There are eight drug master file entries for this compound. Ten 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.
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Summary for SUNITINIB MALATE
| US Patents: | 0 |
| Applicants: | 7 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 8 |
| Raw Ingredient (Bulk) Api Vendors: | 81 |
| Clinical Trials: | 175 |
| Patent Applications: | 1,124 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wanbang Biopharms | SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 218012-004 | Aug 21, 2023 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys | SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 215843-001 | Apr 11, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sun Pharm | SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 213914-002 | Aug 16, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 213803-004 | Nov 30, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Eugia Pharma | SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 218615-003 | Mar 14, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys | SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 215843-004 | Apr 11, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | SUNITINIB MALATE | sunitinib malate | CAPSULE;ORAL | 201275-004 | Dec 6, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
