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Fish and Richardson
Cantor Fitzgerald
McKesson
US Army
Julphar
Federal Trade Commission

Generated: March 21, 2019

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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 sacubitril; valsartan patent protection?

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 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
International Patents:90
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 11
Suppliers / Packagers: 1
Clinical Trials: 29
DailyMed Link:sacubitril; valsartan at DailyMed

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-001 Jul 7, 2015 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp ENTRESTO sacubitril; valsartan TABLET;ORAL 207620-003 Jul 7, 2015 RX Yes Yes ➤ 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

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Supplementary Protection Certificates for sacubitril; valsartan

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1467728 CA 2016 00022 Denmark ➤ Sign Up PRODUCT NAME: SACUBITRIL/VALSARTAN, HERUNDER FARMACEUTISK ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 20151123
1948158 300810 Netherlands ➤ Sign Up 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 1690021-9 Sweden ➤ Sign Up PRODUCT NAME: SACUBITRIL AND VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REG. NO/DATE: EU/1/15/1058 20151123
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Covington
Merck
Johnson and Johnson
Accenture
Moodys

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