GADOBUTROL Drug Patent Profile
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When do Gadobutrol patents expire, and when can generic versions of Gadobutrol launch?
Gadobutrol is a drug marketed by Hainan Poly Pharm and Hengrui Pharma and is included in three NDAs.
The generic ingredient in GADOBUTROL is gadobutrol. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the gadobutrol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Gadobutrol
A generic version of GADOBUTROL was approved as gadobutrol by HENGRUI PHARMA on November 17th, 2022.
Summary for GADOBUTROL
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 3 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 64 |
| Clinical Trials: | 40 |
| Patent Applications: | 728 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | GADOBUTROL at DailyMed |
Recent Clinical Trials for GADOBUTROL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Institutes of Health (NIH) | Early Phase 1 |
| Lipella Pharmaceuticals, Inc. | Early Phase 1 |
| Christopher J Chermansky, MD | Early Phase 1 |
Pharmacology for GADOBUTROL
| Drug Class | Gadolinium-based Contrast Agent |
| Mechanism of Action | Magnetic Resonance Contrast Activity |
Anatomical Therapeutic Chemical (ATC) Classes for GADOBUTROL
US Patents and Regulatory Information for GADOBUTROL
GADOBUTROL is protected by zero US patents and one FDA Regulatory Exclusivity.
FDA Regulatory Exclusivity protecting GADOBUTROL
COMPETITIVE GENERIC THERAPY
Exclusivity Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hainan Poly Pharm | GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 217480-001 | Mar 15, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hengrui Pharma | GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 216081-001 | Sep 8, 2023 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hengrui Pharma | GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 215061-002 | Nov 17, 2022 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hengrui Pharma | GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 216081-002 | Sep 8, 2023 | AP | 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 |
