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Last Updated: March 24, 2023

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
Recent Clinical Trials for sacubitril; valsartan

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Daewoong Pharmaceutical Co. LTD.Phase 4
CardioVascular Research Foundation, KoreaPhase 4
Duk-Woo Park, MDPhase 4

See all sacubitril; valsartan clinical trials

Pharmacology 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 FARMAC√ČUTICAS 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 Farmas√łytiske 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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