Details for New Drug Application (NDA): 022217
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NDA 022217 describes VALTURNA, which is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug. Additional details are available on the VALTURNA profile page.
The generic ingredient in VALTURNA is aliskiren hemifumarate; valsartan. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; valsartan profile page.
The generic ingredient in VALTURNA is aliskiren hemifumarate; valsartan. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; valsartan profile page.
Summary for 022217
| Tradename: | VALTURNA |
| Applicant: | Novartis |
| Ingredient: | aliskiren hemifumarate; valsartan |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022217
Generic Entry Date for 022217*:
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 | EQ 150MG BASE;160MG | ||||
| Approval Date: | Sep 16, 2009 | TE: | RLD: | No | |||||
| Patent: | 8,168,616 | Patent Expiration: | Jul 3, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 300MG BASE;320MG | ||||
| Approval Date: | Sep 16, 2009 | TE: | RLD: | No | |||||
| Patent: | 8,168,616 | Patent Expiration: | Jul 3, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022217
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-001 | Sep 16, 2009 | 5,399,578 | ⤷ Get Started Free |
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | 5,559,111 | ⤷ Get Started Free |
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | 5,399,578 | ⤷ Get Started Free |
| Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-001 | Sep 16, 2009 | 5,559,111 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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