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Details for New Drug Application (NDA): 022128
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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: | 3 |
Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated 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 | |||||
Patent: | Start Trial | Patent Expiration: | Feb 6, 2022 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | Start Trial | Patent Expiration: | May 25, 2023 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Patent: | Start Trial | Patent Expiration: | Nov 25, 2021 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 022128
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Viiv Hlthcare | SELZENTRY | maraviroc | TABLET;ORAL | 022128-004 | Nov 4, 2016 | Start Trial | Start Trial |
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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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