Details for New Drug Application (NDA): 213687
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NDA 213687 describes DOJOLVI, which is a drug marketed by Ultragenyx Pharm Inc and is included in one NDA. It is available from one supplier. There are two patents protecting this drug. Additional details are available on the DOJOLVI profile page.
The generic ingredient in DOJOLVI is triheptanoin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the triheptanoin profile page.
The generic ingredient in DOJOLVI is triheptanoin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the triheptanoin profile page.
Summary for 213687
| Tradename: | DOJOLVI |
| Applicant: | Ultragenyx Pharm Inc |
| Ingredient: | triheptanoin |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 213687
Generic Entry Date for 213687*:
Constraining patent/regulatory exclusivity:
INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS FOR THE TREATMENT OF PEDIATRIC AND ADULT PATIENTS WITH MOLECULARLY CONFIRMED LONG-CHAIN FATTY ACID OXIDATION DISORDERS (LC-FAOD) Dosage:
LIQUID;ORAL |
*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.
Pharmacology for NDA: 213687
Suppliers and Packaging for NDA: 213687
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOJOLVI | triheptanoin | LIQUID;ORAL | 213687 | NDA | Ultragenyx Pharmaceutical Inc. | 69794-050 | 69794-050-50 | 1 BOTTLE, GLASS in 1 CARTON (69794-050-50) / 500 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;ORAL | Strength | 100% w/w | ||||
| Approval Date: | Jun 30, 2020 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 30, 2027 | ||||||||
| Regulatory Exclusivity Use: | INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS FOR THE TREATMENT OF PEDIATRIC AND ADULT PATIENTS WITH MOLECULARLY CONFIRMED LONG-CHAIN FATTY ACID OXIDATION DISORDERS (LC-FAOD) | ||||||||
| Regulatory Exclusivity Expiration: | Jun 30, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 28, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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