Details for New Drug Application (NDA): 205858
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NDA 205858 describes ZYDELIG, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the ZYDELIG profile page.
The generic ingredient in ZYDELIG is idelalisib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the idelalisib profile page.
The generic ingredient in ZYDELIG is idelalisib. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the idelalisib profile page.
Summary for 205858
| Tradename: | ZYDELIG |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | idelalisib |
| Patents: | 8 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205858
Generic Entry Date for 205858*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;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: 205858
| Mechanism of Action | Cytochrome P450 3A Inhibitors Kinase Inhibitors |
Suppliers and Packaging for NDA: 205858
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZYDELIG | idelalisib | TABLET;ORAL | 205858 | NDA | Gilead Sciences, Inc. | 61958-1701 | 61958-1701-1 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1701-1) |
| ZYDELIG | idelalisib | TABLET;ORAL | 205858 | NDA | Gilead Sciences, Inc. | 61958-1702 | 61958-1702-1 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1702-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Jul 23, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 5, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Mar 5, 2033 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | May 12, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | FOR THE TREATMENT OF PATIENTS WITH CLL, FL, OR SLL | ||||||||
Expired US Patents for NDA 205858
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-001 | Jul 23, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-002 | Jul 23, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-001 | Jul 23, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Gilead Sciences Inc | ZYDELIG | idelalisib | TABLET;ORAL | 205858-001 | Jul 23, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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