Details for New Drug Application (NDA): 203100
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NDA 203100 describes STRIBILD, which is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug and one Paragraph IV challenge. Additional details are available on the STRIBILD profile page.
The generic ingredient in STRIBILD is cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate profile page.
The generic ingredient in STRIBILD is cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate profile page.
Summary for 203100
| Tradename: | STRIBILD |
| Applicant: | Gilead Sciences Inc |
| Ingredient: | cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate |
| Patents: | 11 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203100
Generic Entry Date for 203100*:
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: 203100
Suppliers and Packaging for NDA: 203100
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| STRIBILD | cobicistat; elvitegravir; emtricitabine; tenofovir disoproxil fumarate | TABLET;ORAL | 203100 | NDA | Gilead Sciences, Inc. | 61958-1201 | 61958-1201-1 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61958-1201-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG;150MG;200MG;300MG | ||||
| Approval Date: | Aug 27, 2012 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 6, 2033 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Feb 27, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Subscribe | Patent Expiration: | Apr 26, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 203100
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