Details for New Drug Application (NDA): 219627
✉ Email this page to a colleague
NDA 219627 describes AMBELVIST, which is a drug marketed by Bayer Healthcare and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the AMBELVIST profile page.
The generic ingredient in AMBELVIST is gadoquatrane. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gadoquatrane profile page.
The generic ingredient in AMBELVIST is gadoquatrane. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gadoquatrane profile page.
Summary for 219627
| Tradename: | AMBELVIST |
| Applicant: | Bayer Healthcare |
| Ingredient: | gadoquatrane |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219627
Generic Entry Date for 219627*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*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.
Suppliers and Packaging for NDA: 219627
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMBELVIST | gadoquatrane | SOLUTION;INTRAVENOUS | 219627 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-321 | 50419-321-11 | 3 VIAL, SINGLE-DOSE in 1 CARTON (50419-321-11) / 2 mL in 1 VIAL, SINGLE-DOSE (50419-321-01) |
| AMBELVIST | gadoquatrane | SOLUTION;INTRAVENOUS | 219627 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-322 | 50419-322-11 | 10 VIAL, SINGLE-DOSE in 1 CARTON (50419-322-11) / 7.5 mL in 1 VIAL, SINGLE-DOSE (50419-322-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 0.5158GM/2ML (257.9MG/ML) | ||||
| Approval Date: | Jun 12, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 12, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,137,209 | Patent Expiration: | May 30, 2036 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | METHOD OF MAGNETIC RESONANCE IMAGING TO DETECT AND VISUALIZE LESIONS WITH ABNORMAL VASCULARITY IN THE CENTRAL NERVOUS SYSTEM (BRAIN, SPINE, AND ASSOCIATED TISSUES) AND THE BODY (HEAD AND NECK, THORAX, ABDOMEN, PELVIS, AND MUSCULOSKELETAL SYSTEM) | ||||||||
| Patent: | 10,722,601 | Patent Expiration: | May 30, 2036 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
| Patented Use: | METHOD OF MAGNETIC RESONANCE IMAGING TO DETECT AND VISUALIZE LESIONS WITH ABNORMAL VASCULARITY IN THE CENTRAL NERVOUS SYSTEM (BRAIN, SPINE, AND ASSOCIATED TISSUES) AND THE BODY (HEAD AND NECK, THORAX, ABDOMEN, PELVIS, AND MUSCULOSKELETAL SYSTEM) | ||||||||
Complete Access Available with Subscription
