Details for New Drug Application (NDA): 209939
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NDA 209939 describes PREVYMIS, which is a drug marketed by MSD and Merck Sharp Dohme and is included in three NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the PREVYMIS profile page.
The generic ingredient in PREVYMIS is letermovir. One supplier is listed for this compound. Additional details are available on the letermovir profile page.
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 209939
| Tradename: | PREVYMIS |
| Applicant: | Merck Sharp Dohme |
| Ingredient: | letermovir |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209939
Generic Entry Date for 209939*:
Constraining patent/regulatory exclusivity:
PROPHYLAXIS OF CYTOMEGALOVIRUS (CMV) DISEASE IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER AND WEIGHING AT LEAST 40 KG WHO ARE KIDNEY TRANSPLANT RECIPIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE [D+/R-]) 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: 209939
Suppliers and Packaging for NDA: 209939
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PREVYMIS | letermovir | TABLET;ORAL | 209939 | NDA | Merck Sharp & Dohme LLC | 0006-3075 | 0006-3075-02 | 4 DOSE PACK in 1 CARTON (0006-3075-02) / 7 TABLET, FILM COATED in 1 DOSE PACK (0006-3075-01) |
| PREVYMIS | letermovir | TABLET;ORAL | 209939 | NDA | Merck Sharp & Dohme LLC | 0006-3075 | 0006-3075-04 | 14 BLISTER PACK in 1 CARTON (0006-3075-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK (0006-3075-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 240MG | ||||
| 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 209939
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | PREVYMIS | letermovir | TABLET;ORAL | 209939-001 | Nov 8, 2017 | 8,513,255 | ⤷ Subscribe |
| Merck Sharp Dohme | PREVYMIS | letermovir | TABLET;ORAL | 209939-001 | Nov 8, 2017 | 7,196,086 | ⤷ Subscribe |
| Merck Sharp Dohme | PREVYMIS | letermovir | TABLET;ORAL | 209939-002 | Nov 8, 2017 | 7,196,086 | ⤷ Subscribe |
| Merck Sharp Dohme | PREVYMIS | letermovir | TABLET;ORAL | 209939-002 | Nov 8, 2017 | 8,513,255 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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