VALTURNA Drug Patent Profile
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When do Valturna patents expire, and when can generic versions of Valturna launch?
Valturna is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug.
This drug has ninety-three patent family members in thirty-one countries.
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.
DrugPatentWatch® Generic Entry Outlook for Valturna
Valturna was eligible for patent challenges on March 5, 2011.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be July 3, 2026. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VALTURNA
International Patents: | 93 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Clinical Trials: | 1 |
Patent Applications: | 6 |
Formulation / Manufacturing: | see details |
DailyMed Link: | VALTURNA at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VALTURNA
Generic Entry Date for VALTURNA*:
Constraining patent/regulatory exclusivity:
NDA:
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.
Recent Clinical Trials for VALTURNA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Novartis Pharmaceuticals | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for VALTURNA
US Patents and Regulatory Information for VALTURNA
VALTURNA is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VALTURNA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting VALTURNA
Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-001 | Sep 16, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for VALTURNA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-001 | Sep 16, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-001 | Sep 16, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VALTURNA
See the table below for patents covering VALTURNA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 334002 | ⤷ Try a Trial | |
Germany | 59107440 | ⤷ Try a Trial | |
Slovakia | 287881 | ⤷ Try a Trial | |
South Korea | 0171409 | ⤷ Try a Trial | |
Portugal | 1341533 | ⤷ Try a Trial | |
European Patent Office | 1930000 | ⤷ Try a Trial | |
Japan | 2004513920 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VALTURNA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0443983 | 23/1997 | Austria | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN ODER EIN PHARMAZEUTISCH VERWENDBARES SALZ ODER EIN ESTER DAVON; NAT. REGISTRATION NO/DATE: 1-21751 UND 1-21752 19961220; FIRST REGISTRATION: DE 36983.00.00 36983.01.00 19960513 |
0678503 | 91564 | Luxembourg | ⤷ Try a Trial | 91564, EXPIRES: 20200407 |
0678503 | C300296 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN OF EEN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822 |
1507558 | 132012902049405 | Italy | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN, AMLODIPINA, IDROCLOROTIAZIDE(RASITRIO); AUTHORISATION NUMBER(S) AND DATE(S): 61678/01/02/03/04/05, 20110705;EU/1/11/730/001-060, 20111122 |
1915993 | 132013902215595 | Italy | ⤷ Try a Trial | PRODUCT NAME: ALISKIREN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E AMLODIPINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(RASILAMLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/686/001-056, 20110414 |
1915993 | CA 2013 00062 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION OMFATTENDE ALISKIREN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HEMIFUMARAT, OG AMLODIPIN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BENSYLAT; REG. NO/DATE: EU/1/11/686/001/056 20110418 |
0443983 | 97C0050 | France | ⤷ Try a Trial | PRODUCT NAME: VALSARTAN; REGISTRATION NO/DATE IN FRANCE: NL 22077 DU 19970321; REGISTRATION NO/DATE AT EEC: 369830000 DU 19960513 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |