Sacubitril; valsartan - Generic Drug Details
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What are the generic sources for sacubitril; valsartan and what is the scope of freedom to operate?
Sacubitril; valsartan
is the generic ingredient in one branded drug marketed by Novartis Pharms Corp and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.Sacubitril; valsartan has one hundred and forty-five patent family members in forty-one countries.
One supplier is listed for this compound.
Summary for sacubitril; valsartan
International Patents: | 145 |
US Patents: | 10 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 85 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for sacubitril; valsartan |
DailyMed Link: | sacubitril; valsartan at DailyMed |
Recent Clinical Trials for sacubitril; valsartan
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Daewoong Pharmaceutical Co. LTD. | Phase 4 |
CardioVascular Research Foundation, Korea | Phase 4 |
Duk-Woo Park, MD | Phase 4 |
Pharmacology for sacubitril; valsartan
Drug Class | Angiotensin 2 Receptor Blocker Neprilysin Inhibitor |
Mechanism of Action | Angiotensin 2 Receptor Antagonists Neprilysin Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for sacubitril; valsartan
Paragraph IV (Patent) Challenges for SACUBITRIL; VALSARTAN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ENTRESTO | Tablets | sacubitril; valsartan | 24 mg/26 mg, 49 mg/51 mg 97 mg/103 mg | 207620 | 18 | 2019-07-08 |
US Patents and Regulatory Information for sacubitril; valsartan
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis Pharms Corp | ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620-003 | Jul 7, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Novartis Pharms Corp | ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620-001 | Jul 7, 2015 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Novartis Pharms Corp | ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620-003 | Jul 7, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Novartis Pharms Corp | ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620-003 | Jul 7, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for sacubitril; valsartan
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Novartis Europharm Limited | Neparvis | sacubitril, valsartan | EMEA/H/C/004343 Neparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction., |
Authorised | no | no | no | 2016-05-26 | |
Novartis Europharm Limited | Entresto | sacubitril, valsartan | EMEA/H/C/004062 Entresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction., |
Authorised | no | no | no | 2015-11-19 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for sacubitril; valsartan
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ecuador | SP14019136 | COMBINACIONES FARMACÉUTICAS DE UN ANTAGONISTA DEL RECEPTOR DE ANGIOTENSINA Y UN INHIBIDOR DE ENDOPEPTIDASA NEUTRA (NEP) | See Plans and Pricing |
Lithuania | PA2021502 | See Plans and Pricing | |
Norway | 20151656 | Farmasøytiske kombinasjoner av en angiotensinreseptorantagonist og en nepinhibitor | See Plans and Pricing |
Australia | 2006311481 | Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for sacubitril; valsartan
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1948158 | 300810 | Netherlands | See Plans and Pricing | PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, IE. TRINATRIURA (3-((LS,3R)-L-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONYL-L-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-ETHYL-2'-(PENTANOYL(2"-(TETRAZOL-5-YLAAT)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT) HEMIPENTAHYDRAAT; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123 |
1467728 | 19/2016 | Austria | See Plans and Pricing | PRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119 |
1467728 | 122016000037 | Germany | See Plans and Pricing | PRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119 |
2340828 | 301088 | Netherlands | See Plans and Pricing | PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, DAT WIL ZEGGEN (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIFENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIFENYL-4-YL-4-(3-CARBOXYPROPIONYLAMINO)-2-METHYL-PENTAANZUURETHYLESTER))NA3-X H2O, WAARBIJ X 0 TOT EN MET 3 IS; REGISTRATION NO/DATE: EU/1/15/1058 20151123 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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