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ENTRESTO Drug Profile
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When do Entresto patents expire, and what generic alternatives are available?
Entresto is a drug marketed by Novartis Pharms Corp and is included in one NDA. There are six patents protecting this drug.
This drug has one hundred patent family members in thirty-eight countries.
The generic ingredient in ENTRESTO is sacubitril; valsartan. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
US ANDA Litigation and Generic Entry Outlook for Entresto
Entresto was eligible for patent challenges on July 7, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 27, 2027. This may change due to patent challenges or generic licensing.
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for ENTRESTO
International Patents: | 100 |
US Patents: | 6 |
Applicants: | 1 |
NDAs: | 1 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 18 |
Clinical Trials: | 34 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ENTRESTO |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ENTRESTO |
What excipients (inactive ingredients) are in ENTRESTO? | ENTRESTO excipients list |
DailyMed Link: | ENTRESTO at DailyMed |


Generic Entry Opportunity Date for ENTRESTO
Generic Entry Date for ENTRESTO*:
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 ENTRESTO
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Yale University | Phase 4 |
Hospital Geral Roberto Santos | Phase 2 |
Hospital Universitário Professor Edgard Santos | Phase 2 |
Pharmacology for ENTRESTO
Drug Class | Neprilysin Inhibitor Angiotensin 2 Receptor Blocker |
Mechanism of Action | Neprilysin Inhibitors Angiotensin 2 Receptor Antagonists |
Paragraph IV (Patent) Challenges for ENTRESTO
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
ENTRESTO | TABLET;ORAL | sacubitril; valsartan | 207620 | 2019-07-08 |
US Patents and Regulatory Information for ENTRESTO
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 | Start Trial | Start Trial | Start Trial | ||||
Novartis Pharms Corp | ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620-003 | Jul 7, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
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 | 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 | |||
Novartis Pharms Corp | ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620-001 | Jul 7, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ENTRESTO
Country | Patent Number | Estimated Expiration |
---|---|---|
Ecuador | SP14019136 | Start Trial |
Brazil | PI0605921 | Start Trial |
Japan | 2005514441 | Start Trial |
China | 102091330 | Start Trial |
South Africa | 200704717 | Start Trial |
Taiwan | I554504 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ENTRESTO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1467728 | 122016000037 | Germany | Start Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119 |
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 |
1467728 | 132016000051059 | Italy | Start Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN, INCLUSI LORO SALI FARMACEUTICAMENTE ACCETTABILI(ENTRESTO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/15/1058 - C(2015)8288, 20151123 |
1948158 | PA2016017 | Lithuania | Start Trial | PRODUCT NAME: SAKUBITRILAS/VALSARTANAS; REGISTRATION NO/DATE: EU/1/15/1058 20151119 |
1467728 | 300811 | Netherlands | Start Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN, MET INBEGRIP VAN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/15/1058 (C(2015) 8288) 20151123 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |