Details for New Drug Application (NDA): 206510
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NDA 206510 describes DUTREBIS, which is a drug marketed by Merck Sharp Dohme and is included in one NDA. There is one patent protecting this drug. Additional details are available on the DUTREBIS profile page.
The generic ingredient in DUTREBIS is lamivudine; raltegravir potassium. There are twenty-nine drug master file entries for this compound. Additional details are available on the lamivudine; raltegravir potassium profile page.
The generic ingredient in DUTREBIS is lamivudine; raltegravir potassium. There are twenty-nine drug master file entries for this compound. Additional details are available on the lamivudine; raltegravir potassium profile page.
Summary for 206510
| Tradename: | DUTREBIS |
| Applicant: | Merck Sharp Dohme |
| Ingredient: | lamivudine; raltegravir potassium |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 206510
Generic Entry Date for 206510*:
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.
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 150MG;EQ 300MG BASE | ||||
| Approval Date: | Feb 6, 2015 | TE: | RLD: | No | |||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Sep 11, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 206510
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Merck Sharp Dohme | DUTREBIS | lamivudine; raltegravir potassium | TABLET;ORAL | 206510-001 | Feb 6, 2015 | ⤷ Get Started Free | ⤷ Get Started Free |
| Merck Sharp Dohme | DUTREBIS | lamivudine; raltegravir potassium | TABLET;ORAL | 206510-001 | Feb 6, 2015 | ⤷ Get Started Free | ⤷ Get Started Free |
| Merck Sharp Dohme | DUTREBIS | lamivudine; raltegravir potassium | TABLET;ORAL | 206510-001 | Feb 6, 2015 | ⤷ Get Started Free | ⤷ Get Started Free |
| Merck Sharp Dohme | DUTREBIS | lamivudine; raltegravir potassium | TABLET;ORAL | 206510-001 | Feb 6, 2015 | ⤷ Get Started Free | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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