Details for New Drug Application (NDA): 205395
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NDA 205395 describes PREZCOBIX, which is a drug marketed by Janssen Prods and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the PREZCOBIX profile page.
The generic ingredient in PREZCOBIX is cobicistat; darunavir. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cobicistat; darunavir profile page.
The generic ingredient in PREZCOBIX is cobicistat; darunavir. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cobicistat; darunavir profile page.
Summary for 205395
| Tradename: | PREZCOBIX |
| Applicant: | Janssen Prods |
| Ingredient: | cobicistat; darunavir |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205395
Generic Entry Date for 205395*:
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: 205395
Suppliers and Packaging for NDA: 205395
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395 | NDA | A-S Medication Solutions | 50090-1723 | 50090-1723-0 | 30 TABLET, FILM COATED in 1 BOTTLE (50090-1723-0) |
| PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395 | NDA | Janssen Products LP | 59676-575 | 59676-575-30 | 30 TABLET, FILM COATED in 1 BOTTLE (59676-575-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG;800MG | ||||
| Approval Date: | Jan 29, 2015 | TE: | RLD: | Yes | |||||
| Patent: | 10,039,718 | Patent Expiration: | Oct 6, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 7,700,645*PED | Patent Expiration: | Jun 26, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 8,148,374 | Patent Expiration: | Sep 3, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT OF HIV INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE | ||||||||
Expired US Patents for NDA 205395
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | 9,889,115 | ⤷ Subscribe |
| Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | 5,843,946*PED | ⤷ Subscribe |
| Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | RE43596*PED | ⤷ Subscribe |
| Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | RE42889*PED | ⤷ Subscribe |
| Janssen Prods | PREZCOBIX | cobicistat; darunavir | TABLET;ORAL | 205395-001 | Jan 29, 2015 | 8,597,876*PED | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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