US Patents for PCT: WO2010/054294
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Genentech Inc | ESBRIET | pirfenidone | CAPSULE;ORAL | 022535-001 | Oct 15, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN USE OF PIRFENIDONE | |||
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-001 | Jan 11, 2017 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, THEN SUB-1600 MG/DAY, THEN AT LEAST 1602 MG/DAY | |||
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-001 | Jan 11, 2017 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING A SUB-1600 MG/DAY DOSE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY | |||
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-001 | Jan 11, 2017 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY ADMINISTERING SUB-2400 MG/DAY DOSE, FOLLOWED BY FULL DAILY DOSE | |||
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-001 | Jan 11, 2017 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE UNTIL BIOMARKERS OF LIVER FUNCTION ARE WITHIN NORMAL LIMITS, FOLLOWED BY FULL DAILY DOSE | |||
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-001 | Jan 11, 2017 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | DOSAGE MODIFICATION FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION, BY DISCONTINUING PIRFENIDONE, FOLLOWED BY ADMINISTERING AT LEAST 1602 MG/DAY | |||
| Genentech Inc | ESBRIET | pirfenidone | TABLET;ORAL | 208780-001 | Jan 11, 2017 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | DOSING AT LEAST 1602 MG/DAY FOLLOWING GRADE 2 ABNORMALITY IN LIVER FUNCTION BIOMARKER ALT OR AST AFTER PIRFENIDONE ADMINISTRATION | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Patented / Exclusive Use |
