DrugPatentWatch Database Preview
ENTRESTO Drug Profile
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 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.
Summary for ENTRESTO
| International Patents: | 90 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 17 |
| Clinical Trials: | 24 |
| 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 |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Phase 4 |
| Ohio State University | Phase 4 |
| University of Copenhagen | Phase 4 |
Recent Litigation for ENTRESTO
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| NOVARTIS PHARMACEUTICALS CORPORATION v. MACLEODS PHARMACEUTICALS LTD. | 2019-10-25 |
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 | 207620-001 | 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 | 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 | ||||
| Novartis Pharms Corp | ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620-001 | Jul 7, 2015 | RX | Yes | No | 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 |
International Patents for ENTRESTO
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Croatia | P20140274 | Start Trial |
| Cyprus | 1115004 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2007056546 | Start Trial |
| Canada | 2590511 | 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 |
| 1948158 | 122016000038 | Germany | Start Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS SACUBITRIL VALSARTAN NATRIUM SALZKOMPLEX, D.H. TRINATRIUM-(3-((1 S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAT-(S)-3'-METHYL-2'-(PENTANOYL-(2"-(TETRAZOL-5-YLAT)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRAT)-HEMIPENTAHYDRAT.; REGISTRATION NO/DATE: EU/1/15/1058 20151119 |
| 1467728 | 122016000037 | Germany | Start Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN, EINSCHLIESSLICH PHARMAZEUTISCH ANNEHMBARER SALZE DAVON; REGISTRATION NO/DATE: EU/1/15/1058 20151119 |
| 1948158 | CA 2016 00023 | Denmark | Start Trial | PRODUCT NAME: SACUBITRIL/VALSARTAN SOM SACUBITRIL-VALSARTAN-NATRIUMSALTKOMPLEKS; REG. NO/DATE: EU/1/15/1058 (C(2015)8288) 20151123 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
