SYNJARDY Drug Patent Profile
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Which patents cover Synjardy, and what generic alternatives are available?
Synjardy is a drug marketed by Boehringer Ingelheim and is included in two NDAs. There are ten patents protecting this drug and one Paragraph IV challenge.
This drug has two hundred and forty-six patent family members in forty-five countries.
The generic ingredient in SYNJARDY is empagliflozin; metformin hydrochloride. There are twenty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the empagliflozin; metformin hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Synjardy
Synjardy was eligible for patent challenges on August 1, 2018.
There have been thirteen patent litigation cases 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
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Summary for SYNJARDY
| International Patents: | 246 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 1 |
| Drug Prices: | Drug price information for SYNJARDY |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SYNJARDY |
| What excipients (inactive ingredients) are in SYNJARDY? | SYNJARDY excipients list |
| DailyMed Link: | SYNJARDY at DailyMed |
Recent Clinical Trials for SYNJARDY
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hikma Pharma | Phase 1 |
| Genuine Research Center, Egypt | Phase 1 |
Pharmacology for SYNJARDY
| Drug Class | Biguanide Sodium-Glucose Cotransporter 2 Inhibitor |
| Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Paragraph IV (Patent) Challenges for SYNJARDY
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SYNJARDY | Tablets | empagliflozin; metformin hydrochloride | 5 mg/500 mg 5 mg/1000 mg 12.5 mg/500 mg 12.5 mg/1000 mg | 206111 | 4 | 2018-08-01 |
US Patents and Regulatory Information for SYNJARDY
SYNJARDY is protected by nine US patents and two FDA Regulatory Exclusivities.
Patents protecting SYNJARDY
Pharmaceutical composition, methods for treating and uses thereof
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Pharmaceutical composition, pharmaceutical dosage form, process for their preparation, methods for treating and uses thereof
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Pharmaceutical composition, methods for treating and uses thereof
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Patented Use: METHOD FOR REDUCING THE RISK OF CARDIOVASCULAR DEATH AND HOSPITALIZATION FOR HEART FAILURE IN PATIENTS WITH HEART FAILURE AND TYPE 2 DIABETES MELLITUS BY ADMINISTRATION OF EMPAGLIFLOZIN
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Patented Use: TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR>=45 ML/MIN/1.73 M2 AND
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Patented Use: TREATING TYPE 2 DIABETES MELLITUS BY ASSESSING RENAL FUNCTION AND ORALLY ADMINISTERING EMPAGLIFLOZIN IN A DAILY AMOUNT OF 10 MG OR 25 MG IF THE EGFR IS >=30 ML/MIN/1.73 M2 AND
Glucopyranosyl-substituted phenyl derivatives, medicaments containing such compounds, their use and process for their manufacture
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Crystalline form of 1-chloro-4-(.beta.-D-glucopyranos-1-yl)-2-[4-((S)-tetrahydrofuran-3-yloxy- )-benzyl]-benzene, a method for its preparation and the use thereof for preparing medicaments
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Pharmaceutical composition, methods for treating and uses thereof
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FDA Regulatory Exclusivity protecting SYNJARDY
NEW PATIENT POPULATION
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PEDIATRIC EXCLUSIVITY
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | SYNJARDY XR | empagliflozin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208658-003 | Dec 9, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | SYNJARDY | empagliflozin; metformin hydrochloride | TABLET;ORAL | 206111-003 | Aug 26, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Boehringer Ingelheim | SYNJARDY | empagliflozin; metformin hydrochloride | TABLET;ORAL | 206111-004 | Aug 26, 2015 | RX | Yes | Yes | ⤷ 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 |
International Patents for SYNJARDY
See the table below for patents covering SYNJARDY around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Taiwan | 200538463 | The glucopyranosyl-substituted phenyl derivatives | ⤷ Sign Up |
| Eurasian Patent Organization | 035181 | СПОСОБЫ СНИЖЕНИЯ РИСКА СМЕРТИ ПО ПРИЧИНЕ СЕРДЕЧНО-СОСУДИСТОЙ СМЕРТНОСТИ У ПАЦИЕНТА С САХАРНЫМ ДИАБЕТОМ 2 ТИПА ПУТЕМ ПРИМЕНЕНИЯ ЭМПАГЛИФЛОЗИНА (METHODS FOR REDUCING THE RISK OF DEATH DUE TO CARDIOVASCULAR MORTALITY IN A PATIENT WITH TYPE 2 DIABETES MELLITUS BY USING EMPAGLIFLOZIN) | ⤷ Sign Up |
| Spain | 2314743 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SYNJARDY
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1730131 | 200 5026-2014 | Slovakia | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZIN; REGISTRATION NO/DATE: EU/1/14/930 20140527 |
| 1730131 | PA2014035,C1730131 | Lithuania | ⤷ Sign Up | PRODUCT NAME: EMPAGLIFLOZINUM; REGISTRATION NO/DATE: EU/1/14/930 20140522 |
| 1730131 | 1490061-7 | Sweden | ⤷ Sign Up | PERIOD OF VALIDITY (FROM - UNTIL): 20250312 - 20290526 |
| >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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