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Details for New Drug Application (NDA): 022128
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NDA 022128 describes SELZENTRY, which is a drug marketed by Viiv Hlthcare and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SELZENTRY profile page.
The generic ingredient in SELZENTRY is maraviroc. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the maraviroc profile page.
The generic ingredient in SELZENTRY is maraviroc. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the maraviroc profile page.
Summary for 022128
| Tradename: | SELZENTRY |
| Applicant: | Viiv Hlthcare |
| Ingredient: | maraviroc |
| Patents: | 4 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 022128
Generic Entry Date for 022128*:
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: 022128
| Mechanism of Action | Chemokine Co-receptor 5 Antagonists |
Suppliers and Packaging for NDA: 022128
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SELZENTRY | maraviroc | TABLET;ORAL | 022128 | NDA | ViiV Healthcare Company | 49702-223 | 49702-223-18 | 60 TABLET, FILM COATED in 1 BOTTLE (49702-223-18) |
| SELZENTRY | maraviroc | TABLET;ORAL | 022128 | NDA | ViiV Healthcare Company | 49702-224 | 49702-224-18 | 60 TABLET, FILM COATED in 1 BOTTLE (49702-224-18) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 150MG | ||||
| Approval Date: | Aug 6, 2007 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 4, 2019 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Nov 4, 2019 | ||||||||
| Regulatory Exclusivity Use: | NEW STRENGTH | ||||||||
| Patent: | Start Trial | Patent Expiration: | Dec 1, 2019 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF TREATING PATIENTS INFECTED WITH CCR5-TROPIC HIV-1 | ||||||||
Expired US Patents for NDA 022128
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-003 | Nov 4, 2016 | Start Trial | Start Trial |
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-002 | Aug 6, 2007 | Start Trial | Start Trial |
| Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-001 | Aug 6, 2007 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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