Details for New Drug Application (NDA): 022535
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NDA 022535 describes ESBRIET, which is a drug marketed by Genentech Inc and is included in two NDAs. It is available from one supplier. There are twenty patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ESBRIET profile page.
The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.
The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the pirfenidone profile page.
Summary for 022535
| Tradename: | ESBRIET |
| Applicant: | Genentech Inc |
| Ingredient: | pirfenidone |
| Patents: | 19 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 022535
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESBRIET | pirfenidone | CAPSULE;ORAL | 022535 | NDA | Genentech, Inc. | 50242-121 | 50242-121-01 | 1 BOTTLE, PLASTIC in 1 CARTON (50242-121-01) / 270 CAPSULE in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 267MG | ||||
| Approval Date: | Oct 15, 2014 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 22, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 22, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 18, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS | ||||||||
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