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
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Questions you can ask:
- What is the 5 year forecast for VALTURNA?
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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 |
![VALTURNA drug patent expirations Drug patent expirations by year for VALTURNA](/p/graph/s/t/VALTURNA-patent-expirations.png)
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 |
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 | 022217-001 | Sep 16, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-001 | Sep 16, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | VALTURNA | aliskiren hemifumarate; valsartan | TABLET;ORAL | 022217-002 | Sep 16, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Netherlands | 300386 | ⤷ Sign Up | |
Russian Federation | 2310443 | СИНЕРГЕТИЧЕСКИЕ КОМПОЗИЦИИ, КОТОРЫЕ СОДЕРЖАТ ИНГИБИТОР РЕНИНА, ПРЕДНАЗНАЧЕННЫЕ ДЛЯ ЛЕЧЕНИЯ СЕРДЕЧНО-СОСУДИСТЫХ ЗАБОЛЕВАНИЙ (RENIN INHIBITOR-CONTAINING SYNERGETIC COMPOSITIONS DESIGNATED FOR TREATMENT OF CARDIOVASCULAR DISEASE) | ⤷ Sign Up |
Russian Federation | 95105970 | ⤷ Sign Up | |
Israel | 217847 | ⤷ Sign Up | |
China | 100404024 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VALTURNA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2305232 | 301005 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/08/491 20090120 |
0678503 | 91564 | Luxembourg | ⤷ Sign Up | 91564, EXPIRES: 20200407 |
1915993 | CA 2013 00062 | Denmark | ⤷ Sign Up | 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 |
1915993 | 2013/058 | Ireland | ⤷ Sign Up | 2013/058 DECLARED INVALID WITH ARTICLE 15 1C OF REGULATION EC NO. 469/2009 |
0678503 | C300296 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ALISKIREN OF EEN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |