Details for New Drug Application (NDA): 209940
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The generic ingredient in PREVYMIS is letermovir. One supplier is listed for this compound. Additional details are available on the letermovir profile page.
Summary for 209940
Tradename: | PREVYMIS |
Applicant: | Merck Sharp Dohme |
Ingredient: | letermovir |
Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209940
Generic Entry Date for 209940*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INTRAVENOUS |
*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: 209940
Suppliers and Packaging for NDA: 209940
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PREVYMIS | letermovir | SOLUTION;INTRAVENOUS | 209940 | NDA | Merck Sharp & Dohme LLC | 0006-5003 | 0006-5003-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-5003-01) / 12 mL in 1 VIAL, SINGLE-DOSE (0006-5003-02) |
PREVYMIS | letermovir | SOLUTION;INTRAVENOUS | 209940 | NDA | Merck Sharp & Dohme LLC | 0006-5004 | 0006-5004-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0006-5004-01) / 24 mL in 1 VIAL, SINGLE-DOSE (0006-5004-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 240MG/12ML (20MG/ML) | ||||
Approval Date: | Nov 8, 2017 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Aug 2, 2026 | ||||||||
Regulatory Exclusivity Use: | EXTENSION OF LETERMOVIR DOSING REGIMEN FROM 100 TO 200 DAYS POST-TRANSPLANT FOR THE PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) INFECTION AND DISEASE IN ADULT CMV SEROPOSITIVE RECIPIENTS (R+) OF AN ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANT WHO ARE AT RISK FOR LATE CMV INFECTION AND DISEASE | ||||||||
Regulatory Exclusivity Expiration: | Jun 5, 2030 | ||||||||
Regulatory Exclusivity Use: | FOR PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]) | ||||||||
Regulatory Exclusivity Expiration: | Aug 30, 2027 | ||||||||
Regulatory Exclusivity Use: | NEW PATIENT POPULATION |
Expired US Patents for NDA 209940
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck Sharp Dohme | PREVYMIS | letermovir | SOLUTION;INTRAVENOUS | 209940-001 | Nov 8, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Merck Sharp Dohme | PREVYMIS | letermovir | SOLUTION;INTRAVENOUS | 209940-001 | Nov 8, 2017 | ⤷ Sign Up | ⤷ Sign Up |
Merck Sharp Dohme | PREVYMIS | letermovir | SOLUTION;INTRAVENOUS | 209940-002 | Nov 8, 2017 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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