ENTRESTO SPRINKLE Drug Patent Profile
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When do Entresto Sprinkle patents expire, and when can generic versions of Entresto Sprinkle launch?
Entresto Sprinkle is a drug marketed by Novartis and is included in one NDA. There are four patents protecting this drug.
This drug has one hundred and twenty-seven patent family members in forty countries.
The generic ingredient in ENTRESTO SPRINKLE 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 Sprinkle
A generic version of ENTRESTO SPRINKLE was approved as sacubitril; valsartan by ALEMBIC on May 28th, 2024.
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Summary for ENTRESTO SPRINKLE
| International Patents: | 127 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ENTRESTO SPRINKLE |
| DailyMed Link: | ENTRESTO SPRINKLE at DailyMed |
Pharmacology for ENTRESTO SPRINKLE
| Drug Class | Angiotensin 2 Receptor Blocker Neprilysin Inhibitor |
| Mechanism of Action | Angiotensin 2 Receptor Antagonists Neprilysin Inhibitors |
US Patents and Regulatory Information for ENTRESTO SPRINKLE
ENTRESTO SPRINKLE is protected by four US patents.
Patents protecting ENTRESTO SPRINKLE
Galenic formulations of organic compounds
Patent Number: ⤷ Sign Up
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Patented Use: TREATMENT OF HEART FAILURE WITH ORAL PELLETS
Methods of treatment and pharmaceutical composition
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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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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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Patented Use: TREATMENT OF HEART FAILURE
| 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 | 218591-001 | 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 | Y | Y | ⤷ Sign Up | ||
| Novartis | ENTRESTO SPRINKLE | sacubitril; valsartan | CAPSULE, PELLETS;ORAL | 218591-001 | Apr 12, 2024 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| 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 | ⤷ 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 | |||
| >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 SPRINKLE
| 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 SPRINKLE
When does loss-of-exclusivity occur for ENTRESTO SPRINKLE?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 7882
Patent: COMPUESTOS DE ACCION DOBLE DE BLOQUEADORES DEL RECEPTOR DE ANGIOTENSINA E INHIBIDORES DE ENDOPEPTIDASA NEUTRA
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Patent: 6613
Patent: [HEMI-PENTAHIDRATO DE [3-((1S,3R)-1-BIFENIL-4-ILMETIL-3-ETOXI-CARBONIL-1-BUTIL-CARBAMOIL)-PROPIONATO-(S)-3 -METIL-2 -(PENTANOIL-{2 -(TETRAZOL-5-ILATO)-BIFENIL-4 -ILMETIL}-AMINO)-BUTIRATO] DE TRISODIO
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Patent: 6614
Patent: COMPUESTOS ORGÁNICOS
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Australia
Patent: 06311481
Patent: Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor
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Brazil
Patent: 0605921
Patent: compostos orgánicos
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Patent: 2013025375
Patent: compostos orgânicos, seus métodos de preparo e uso, bem como composições farmacêuticas
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Canada
Patent: 90511
Patent: COMBINAISON PHARMACEUTIQUES D'UN ANTAGONISTE DE RECEPTEUR D'ANGIOTENSINE ET D'UN INHIBITEUR DE NEP (PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR)
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China
Patent: 1098689
Patent: Pharmaceutical combinations of an angiotensin receptor antagonist and an nep inhibitor
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Patent: 2702119
Patent: Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor
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Croatia
Patent: 0140274
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Patent: 0201605
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Cyprus
Patent: 15004
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Patent: 23531
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Patent: 16014
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 48158
Estimated Expiration: ⤷ Sign Up
Patent: 40828
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 14019136
Patent: COMBINACIONES FARMACÉUTICAS DE UN ANTAGONISTA DEL RECEPTOR DE ANGIOTENSINA Y UN INHIBIDOR DE ENDOPEPTIDASA NEUTRA (NEP)
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 48158
Patent: COMBINAISON PHARMACEUTIQUES D'UN ANTAGONISTE DE RECEPTEUR D'ANGIOTENSINE ET D'UN INHIBITEUR DE NEP (PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 40828
Patent: Combinaisons pharmaceutiques d'un antagoniste de récepteur de l'angiotensine et inhibiteurs de nep (PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 85833
Patent: COMPOSÉ COMPRENANT UN ARB ET UN NEPI (COMPOUND COMPRISING AN ARB AND A NEPI)
Estimated Expiration: ⤷ Sign Up
France
Patent: C0018
Estimated Expiration: ⤷ Sign Up
Patent: C1000
Estimated Expiration: ⤷ Sign Up
Guatemala
Patent: 0700055
Patent: COMBINACIONES FARMACEUTICAS DE UN ANTAGONISTA DEL RECEPTOR DE ANGIOTENSINA Y UN INHIBIDOR DE ENDOPEPTIDASA NEUTRAL (NEP).
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Hong Kong
Patent: 21371
Patent: PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR
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Patent: 75465
Patent: 血管緊張素受體拮抗劑和 抑制劑的藥物組合產品 (PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR NEP)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 50870
Estimated Expiration: ⤷ Sign Up
Patent: 600025
Estimated Expiration: ⤷ Sign Up
Patent: 100003
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4027
Patent: תרכובת טריסודיום [3-((1s, 3r)-1-ביפניל-4-ילמתיל-3-אתוקסיקרבוניל-1-בוטילקרבמויל)פרופיונאט-(s)-'3-מתיל-'2-(פנטהנויל{" 2-(טטרזול-5-ילאט)ביפניל-'4-ילמתיל}אמינו)בוטיראט] המיפנטההידראט, תכשירים רוקחיים שלה, שיטה להכנתה ושימוש בה להכנת תרופות (Compound trisodium [3-((1s,3r)-1-biphenyl-4-ylmethyl-3-ethoxycarbonyl-1-butylcarbamoyl)propionate-(s)-3’-methyl-2’-(pentanoyl{2’’-(tetrazol-5-ylate)biphenyl-4’-ylmethyl}amino)butyrate] hemipentahydrate, its pharmaceutical compositions, method for its preparation and use thereof in the preparation of medicaments)
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Japan
Patent: 24754
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Patent: 08542447
Estimated Expiration: ⤷ Sign Up
Patent: 11252013
Patent: PHARMACEUTICAL COMBINATION OF ANGIOTENSIN RECEPTOR ANTAGONIST AND NEP INHIBITOR
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Patent: 15098485
Patent: アンギオテンシン受容体遮断剤とＮＥＰ阻害剤との医薬組成物 (PHARMACEUTICAL COMBINATIONS OF ANGIOTENSIN RECEPTOR ANTAGONIST AND NEP INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Jordan
Patent: 92
Patent: تركيبات صيدلانية من مضاد مستقبل أنجيوتنسين ومثبط NEP (PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 948158
Estimated Expiration: ⤷ Sign Up
Patent: 2021502
Estimated Expiration: ⤷ Sign Up
Patent: 40828
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 5462
Patent: PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 07008075
Patent: COMBINACIONES FARMACEUTICAS DE UN ANTAGONISTA DEL RECEPTOR DE ANGIOTENSINA Y UN INHIBIDOR DE ENDOPEPTIDASA NEUTRAL (NEP). (PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR.)
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 128
Patent: COMBINAISONS PHARMACEUTIQUES D'UN ANTAGONISTE DE RECEPTUER D'ANGIOTENSINE ET D'UN INHIBITEUR DE NEP
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New Zealand
Patent: 4006
Patent: Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor
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Patent: 0626
Patent: Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor
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Norway
Patent: 7288
Estimated Expiration: ⤷ Sign Up
Patent: 0315
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Patent: 16008
Estimated Expiration: ⤷ Sign Up
Patent: 073396
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Patent: 151656
Patent: Farmasøytiske kombinasjoner av en angiotensinreseptorantagonist og en nepinhibitor
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Peru
Patent: 070803
Patent: COMBINACION FARMACEUTICA DE UN ANTAGONISTA DEL RECEPTOR DE ANGIOTENSINA Y UN INHIBIDOR DE ENDOPEPTIDASA NEUTRA
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Patent: 190374
Patent: COMBINACION FARMACEUTICA DE UN ANTAGONISTA DEL RECEPTOR DE ANGIOTENSINA Y UN INHIBIDOR DE ENDOPEPTIDASA NEUTRA
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 48158
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Portugal
Patent: 48158
Estimated Expiration: ⤷ Sign Up
Patent: 40828
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Russian Federation
Patent: 59809
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМБИНАЦИИ АНТАГОНИСТА РЕЦЕПТОРА АНГИОТЕНЗИНА И ИНГИБИТОРА NEP (PHARMACEUTICAL COMBINATIONS OF ANGIOTENSINE RECEPTOR ANTAGONIST AND NEP INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 03668
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМБИНАЦИИ АНТАГОНИСТА РЕЦЕПТОРА АНГИОТЕНЗИНА И ИНГИБИТОРА NEP (PHARMACEUTICAL COMBINATIONS OF ANGIOTENSIN RECEPTOR ANTAGONIST AND NEP INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 07123671
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМБИНАЦИИ АНТАГОНИСТА РЕЦЕПТОРА АНГИОИЕНЗИНА И ИНГИБИТОРА NEP
Estimated Expiration: ⤷ Sign Up
Patent: 12107219
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМБИНАЦИИ АНТАГОНИСТА РЕЦЕПТОРА АНГИОТЕНЗИНА И ИНГИБИТОРА NEP
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201402055Y
Patent: PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 48158
Estimated Expiration: ⤷ Sign Up
Patent: 40828
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0704717
Patent: Pharmaceutical combinations of an angiotensin receptor antagonist and an NEP inhibitor
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1432821
Estimated Expiration: ⤷ Sign Up
Patent: 1549318
Estimated Expiration: ⤷ Sign Up
Patent: 080075055
Patent: PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR
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Patent: 130116381
Patent: PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 49765
Estimated Expiration: ⤷ Sign Up
Patent: 23749
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 18348
Estimated Expiration: ⤷ Sign Up
Patent: 54504
Estimated Expiration: ⤷ Sign Up
Patent: 0803834
Patent: Organic compounds
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Patent: 1402111
Patent: Dual-acting compound, pharmaceutical composition containing it, process for its preparation and use thereof
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Tunisia
Patent: 07264
Patent: ORGANIC COMPOUNDS
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 SPRINKLE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Hungary | S2100003 | ⤷ Sign Up | |
| Slovenia | 2340828 | ⤷ Sign Up | |
| China | 1615134 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 03059345 | ⤷ Sign Up | |
| Norway | 20043380 | ⤷ Sign Up | |
| Morocco | 30128 | COMBINAISONS PHARMACEUTIQUES D'UN ANTAGONISTE DE RECEPTUER D'ANGIOTENSINE ET D'UN INHIBITEUR DE NEP | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ENTRESTO SPRINKLE
| 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 |
| 1467728 | 16C0019 | France | ⤷ Sign Up | PRODUCT NAME: SACUBITRIL/VALSARTAN,Y COMPRIS LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; 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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