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Last Updated: July 10, 2020

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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 six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sacubitril; valsartan has ninety-two patent family members in thirty-seven countries.

There are eleven drug master file entries for sacubitril; valsartan. 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
Momentum Research, Inc.N/A
AbbottN/A
Saint-Louis-Lariboisière University HospitalsN/A

See all sacubitril; valsartan clinical trials

Paragraph IV (Patent) Challenges for SACUBITRIL; VALSARTAN
Tradename Dosage Ingredient NDA Submissiondate
ENTRESTO TABLET;ORAL sacubitril; valsartan 207620 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 207620-001 Jul 7, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-002 Jul 7, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-003 Jul 7, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for sacubitril; valsartan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1467728 93074 Luxembourg   Start Trial PRODUCT NAME: SACUBITRIL/VALSARTAN, Y COMPRIS LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI; FIRST REGISTRATION DATE: 20151123
1467728 C01467728/01 Switzerland   Start Trial PRODUCT NAME: SACUBRITIL UND VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015
1948158 1690020-1 Sweden   Start Trial PRODUCT NAME: SACUBITRIL AND VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. TRISODIUM 3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3- ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3-METHYL-2- (PENTANOYL2-(TETRAZOL-5-YLATE)BIPHENYL-4- YLMETHYLAMINO)BUTYRATE HEMIPENTAHYDRATE; REG. NO/DATE: EU/1/15/1058 20151123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
AstraZeneca
Colorcon
Boehringer Ingelheim
Harvard Business School
Dow

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