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ENTRESTO Drug Profile
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When do Entresto patents expire, and when can generic versions of Entresto launch?
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 ninety-two patent family members in thirty-seven 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: | 92 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 17 |
| Clinical Trials: | 30 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ENTRESTO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ENTRESTO |
| 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 |
|---|---|
| Momentum Research, Inc. | N/A |
| Abbott | N/A |
| Saint-Louis-Lariboisière University Hospitals | N/A |
Recent Litigation for ENTRESTO
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| IN RE: Entresto (Sacubitril/Valsartan) Patent Litigation | 2019-12-20 |
| NOVARTIS PHARMACEUTICALS CORPORATION v. MACLEODS PHARMACEUTICALS LTD. | 2019-10-25 |
| Novartis Pharmaceuticals Corporation v. Alkem Laboratories Ltd. |
Pharmacology for ENTRESTO
| Drug Class | Neprilysin Inhibitor Angiotensin 2 Receptor Blocker |
| Mechanism of Action | Neprilysin Inhibitors Angiotensin 2 Receptor Antagonists |
Synonyms for ENTRESTO
| 3-(1-Biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-3'-methyl-2'-(pentanoyl(2'-(tetrazol-5-ylate)biphenyl-4'-ylmethyl)amino)butyrate |
| 9052AF |
| AC-29037 |
| ACN-036829 |
| AK198922 |
| AKOS026670199 |
| C96H120N12Na6O21 |
| D10226 |
| Entresto (TN) |
| FT-0700025 |
| LCZ 696 |
| MolPort-042-624-138 |
| Sacubitril mixture with valsartan |
| Sacubitril valsartan sodium hydrate (JAN) |
| UNII-WB8FT61183 |
| Valsartan mixture with AHU-377 |
| WB8FT61183 |
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 | ||||
| >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 |
|---|---|---|
| Japan | 4820056 | Start Trial |
| Japan | 2015098485 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2007056546 | Start Trial |
| South Korea | 101549318 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for ENTRESTO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1467728 | 1690021-9 | Sweden | Start Trial | PRODUCT NAME: SACUBITRIL AND VALSARTAN, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF.; REG. NO/DATE: EU/1/15/1058 20151123 |
| 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 |
| 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
