ENTRESTO Drug Patent 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 Novartis and is included in two NDAs. There are twelve patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and sixty-three patent family members in forty-four countries.
The generic ingredient in ENTRESTO is sacubitril; valsartan. There are eleven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Entresto
A generic version of ENTRESTO was approved as sacubitril; valsartan by ALEMBIC on May 28th, 2024.
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Summary for ENTRESTO
| International Patents: | 163 |
| US Patents: | 8 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 13 |
| Clinical Trials: | 41 |
| Patent Applications: | 22 |
| 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 |
Recent Clinical Trials for ENTRESTO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dr. Reddy's Laboratories (Thailand) Limited | Phase 1 |
| Instituto Nacional de Cardiologia Ignacio Chavez | Phase 2/Phase 3 |
| Boehringer Ingelheim laboratory | Phase 2/Phase 3 |
Pharmacology for ENTRESTO
| Drug Class | Angiotensin 2 Receptor Blocker Neprilysin Inhibitor |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists Neprilysin Inhibitors |
Paragraph IV (Patent) Challenges for ENTRESTO
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ENTRESTO | Tablets | sacubitril; valsartan | 24 mg/26 mg, 49 mg/51 mg 97 mg/103 mg | 207620 | 18 | 2019-07-08 |
US Patents and Regulatory Information for ENTRESTO
ENTRESTO is protected by eight US patents and one FDA Regulatory Exclusivity.
Patents protecting ENTRESTO
Sacubitril-valsartan dosage regimen for treating heart failure
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATING CHRONIC HEART FAILURE WITH REDUCED EJECTION FRACTION IN PATIENTS NOT TAKING AN ACE INHIBITOR OR AN ARB OR PREVIOUSLY TAKING LOW DOSES OF THESE AGENTS, BY TITRATING UP FROM HALF THE USUALLY RECOMMENDED STARTING DOSE
Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
Methods of treatment and pharmaceutical composition
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Methods of treatment and pharmaceutical composition
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Patent Expiration: ⤷ Sign Up
Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl}-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Compounds containing S-N-valeryl-N-{[2'-(1H-tetrazole-5-yl)-biphenyl-4-yl]-methyl)-valine and (2R,4S)-5-biphenyl-4-yl-4-(3-carboxy-propionylamino)-2-methyl-pentanoic acid ethyl ester moieties and cations
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Patent Expiration: ⤷ Sign Up
Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
Inhibitors for treating diseases characterized by atrial enlargement or remodeling
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HEART FAILURE WITH PRESERVED EJECTION FRACTION
FDA Regulatory Exclusivity protecting ENTRESTO
LABELING REVISIONS RELATED TO CLINICAL STUDIES
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | ENTRESTO SPRINKLE | sacubitril; valsartan | CAPSULE, PELLETS;ORAL | 218591-002 | Apr 12, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novartis | ENTRESTO SPRINKLE | sacubitril; valsartan | CAPSULE, PELLETS;ORAL | 218591-001 | Apr 12, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Novartis | ENTRESTO SPRINKLE | sacubitril; valsartan | CAPSULE, PELLETS;ORAL | 218591-002 | Apr 12, 2024 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | ENTRESTO SPRINKLE | sacubitril; valsartan | CAPSULE, PELLETS;ORAL | 218591-001 | Apr 12, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis Pharms Corp | ENTRESTO | sacubitril; valsartan | TABLET;ORAL | 207620-001 | Jul 7, 2015 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for ENTRESTO
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Novartis Europharm Limited | Neparvis | sacubitril, valsartan | EMEA/H/C/004343 Paediatric heart failureNeparvis is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction (see section 5.1).Adult heart failureNeparvis is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction (see section 5.1). |
Authorised | no | no | no | 2016-05-26 | |
| Novartis Europharm Limited | Entresto | sacubitril, valsartan | EMEA/H/C/004062 Paediatric heart failureEntresto is indicated in children and adolescents aged one year or older for treatment of symptomatic chronic heart failure with left ventricular systolic dysfunction.Adult heart failureEntresto is indicated in adult patients for treatment of symptomatic chronic heart failure with reduced ejection fraction. |
Authorised | no | no | no | 2015-11-19 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ENTRESTO
When does loss-of-exclusivity occur for ENTRESTO?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Croatia
Patent: 0230480
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 26036
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 94283
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 94283
Patent: SCHÉMA POSOLOGIQUE DU SACUBITRIL-VALSARTAN POUR LE TRAITEMENT DE L'INSUFFISANCE CARDIAQUE (SACUBITRIL-VALSARTAN DOSAGE REGIMEN FOR TREATING HEART FAILURE)
Estimated Expiration: ⤷ Sign Up
Patent: 12152
Patent: SCHÉMA POSOLOGIQUE DU SACUBUTRIL-VALSARTAN POUR LE TRAITEMENT DE L'INSUFFISANCE CARDIAQUE (SACUBITRIL-VALSARTAN DOSAGE REGIMEN FOR TREATING HEART FAILURE)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 94283
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 62195
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 76469
Estimated Expiration: ⤷ Sign Up
Patent: 18519266
Patent: 心不全の治療のためのサクビトリル−バルサルタンの用量計画
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 94283
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 94283
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 94283
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 242
Patent: REŽIM DOZIRANJA SAKUBITRIL-VALSARTANA ZA LEČENJE SRČANE INSUFICIJENCIJE (SACUBITRIL-VALSARTAN DOSAGE REGIMEN FOR TREATING HEART FAILURE)
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 94283
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 45866
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering ENTRESTO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| New Zealand | 594006 | Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor | ⤷ Sign Up |
| South Korea | 101432821 | ⤷ Sign Up | |
| Japan | 2022020624 | 心房拡大又はリモデリングを特徴とする疾患を治療するためのＮＥＰ阻害剤 | ⤷ Sign Up |
| Brazil | 122013025375 | compostos orgânicos, seus métodos de preparo e uso, bem como composições farmacêuticas | ⤷ Sign Up |
| Canada | 2472399 | COMPOSITIONS PHARMACEUTIQUES A BASE DE VALSARTAN ET D'INHIBITEURS NEP (PHARMACEUTICAL COMPOSITIONS COMPRISING VALSARTAN AND NEP INHIBITORS) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ENTRESTO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2340828 | 2021C/502 | Belgium | ⤷ Sign Up | PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, I.E. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOL-5-YL)-BIFENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIFENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTAANZUURETHYLESTER))NA3 . X H2O, WAARBIJ X 0 TOT 3 IS; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 (C(2015) 8288) 20151123 |
| 1948158 | 1690020-1 | Sweden | ⤷ Sign Up | 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 | C01467728/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: SACUBRITIL UND VALSARTAN; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65673 17.09.2015 |
| 1948158 | 300810 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SACUBITRIL/VALSARTAN, ALS HET SACUBITRIL VALSARTAN NATRIUMZOUTCOMPLEX, IE. TRINATRIUM (3-((LS,3R)-1-BIFENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONAAT-(S)-3'-METHYL-2'-(PENTANOYL(2"-(TETRAZOL-5-YLAAT)BIFENYL-4'-YLMETHYL)AMINO)BUTYRAAT) HEMIPENTAHYDRAAT; REGISTRATION NO/DATE: EU/1/15/1058 20151123 |
| 1467728 | 340 5007-2016 | Slovakia | ⤷ Sign Up | PRODUCT NAME: SAKUBITRIL/VALSARTAN, VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/15/1058 20151123 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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