JENTADUETO XR Drug Patent Profile
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Which patents cover Jentadueto Xr, and what generic alternatives are available?
Jentadueto Xr is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.
This drug has three hundred and seventy-four patent family members in forty-five countries.
The generic ingredient in JENTADUETO XR is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Jentadueto Xr
A generic version of JENTADUETO XR was approved as linagliptin; metformin hydrochloride by SUNSHINE on August 30th, 2021.
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Summary for JENTADUETO XR
| International Patents: | 374 |
| US Patents: | 9 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 3 |
| Clinical Trials: | 1 |
| Patent Applications: | 34 |
| Drug Prices: | Drug price information for JENTADUETO XR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for JENTADUETO XR |
| What excipients (inactive ingredients) are in JENTADUETO XR? | JENTADUETO XR excipients list |
| DailyMed Link: | JENTADUETO XR at DailyMed |
Recent Clinical Trials for JENTADUETO XR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Boehringer Ingelheim | Phase 1 |
Pharmacology for JENTADUETO XR
| Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Paragraph IV (Patent) Challenges for JENTADUETO XR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| JENTADUETO XR | Extended-release Tablets | linagliptin; metformin hydrochloride | 2.5 mg/1000 mg 5 mg/1000 mg | 208026 | 1 | 2018-03-28 |
US Patents and Regulatory Information for JENTADUETO XR
JENTADUETO XR is protected by nine US patents and two FDA Regulatory Exclusivities.
Patents protecting JENTADUETO XR
DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
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Patented Use: LINAGLIPTIN (5 MG DAILY DOSE) AND METFORMIN (WITH OR WITHOUT INSULIN) FOR TREATING TYPE 2 DIABETES PATIENTS WITH RENAL IMPAIRMENT AND INSUFFICIENT GLYCEMIC CONTROL DESPITE PREVIOUS TREATMENT WITH METFORMIN ALONE OR IN COMBINATION WITH INSULIN
8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions
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Uses of DPP-IV inhibitors
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Patent Expiration: ⤷ Sign Up
Process for the preparation of chiral 8-(3-aminopiperidin-1-yl)-xanthines
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DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
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Uses of DPP IV inhibitors
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DPP-IV inhibitor combined with a further antidiabetic agent, tablets comprising such formulations, their use and process for their preparation
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Pharmaceutical composition and uses thereof
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FDA Regulatory Exclusivity protecting JENTADUETO XR
REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-001 | May 27, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-002 | May 27, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-001 | May 27, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-001 | May 27, 2016 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-002 | May 27, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-002 | May 27, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | JENTADUETO XR | linagliptin; metformin hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 208026-001 | May 27, 2016 | 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 |
Expired US Patents for JENTADUETO XR
EU/EMA Drug Approvals for JENTADUETO XR
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim International GmbH | Jentadueto | linagliptin, metformin hydrochloride | EMEA/H/C/002279 Treatment of adult patients with type-2 diabetes mellitus:Jentadueto is indicated as an adjunct to diet and exercise to improve glycaemic control in adult patients inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of linagliptin and metformin.Jentadueto is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and a sulphonylurea. |
Authorised | no | no | no | 2012-07-19 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for JENTADUETO XR
When does loss-of-exclusivity occur for JENTADUETO XR?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 0269
Patent: COMPOSICION FARMACEUTICA Y SUS USOS
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 13229538
Patent: Pharmaceutical compositions comprising metformin and a DPP-4 inhibitor or a SGLT-2 inhibitor
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 66421
Patent: COMPOSITIONS PHARMACEUTIQUES COMPRENANT DE LA METFORMINE ET UN INHIBITEUR DE DPP -4 OU UN INHIBITEUR DE SGLT -2 (PHARMACEUTICAL COMPOSITIONS COMPRISING METFORMIN AND A DPP -4 INHIBITOR OR A SGLT-2 INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 14002325
Patent: Composicion farmaceutica que comprende metformina y un inhibidor de dpp-4 con preferencia linagliptina o un inhibidor de sglt-2 con preferencia 1-cloro-4-(beta-d-glucopiranos-1-il)-2-[4-((s)-tetrahidrofuran-3-iloxi)-bencil]-benceno; y comprimido de administracion oral.
Estimated Expiration: ⤷ Sign Up
China
Patent: 4220049
Patent: Pharmaceutical compositions comprising metformin and DPP -4 inhibitor or SGLT-2 inhibitor
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 1400986
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ МЕТФОРМИН И ИНГИБИТОР DPP-4 ИЛИ ИНГИБИТОР SGLT-2
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 22544
Patent: COMPOSITIONS PHARMACEUTIQUES COMPRENANT DE LA METFORMINE ET UN INHIBITEUR DE DPP -4 OU UN INHIBITEUR DE SGLT -2 (PHARMACEUTICAL COMPOSITIONS COMPRISING METFORMIN AND A DPP -4 INHIBITOR OR A SGLT-2 INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 04953
Patent: 包含二甲雙胍和 抑制劑或 抑制劑的藥物組合物 (PHARMACEUTICAL COMPOSITIONS COMPRISING METFORMIN AND A DPP -4 INHIBITOR OR A SGLT-2 INHIBITOR DPP-4 SGLT-2)
Estimated Expiration: ⤷ Sign Up
India
Patent: 01DEN2014
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 15509519
Patent: メトホルミン及びＤＰＰ−４阻害薬又はＳＧＬＴ−２阻害薬を含む医薬組成物
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 14010560
Patent: COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN METFORMINA Y UN INHIBIDOR DE DPP-4 O UN INHIBIDOR DE SGLT-2. (PHARMACEUTICAL COMPOSITIONS COMPRISING METFORMIN AND A DPP -4 INHIBITOR OR A SGLT-2 INHIBITOR.)
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 014501984
Patent: PHARMACEUTICAL COMPOSITIONS COMPRISING METFORMIN AND A DPP-4 INHIBITOR OR A SGLT-2 INHIBITOR
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201405509U
Patent: PHARMACEUTICAL COMPOSITIONS COMPRISING METFORMIN AND A DPP -4 INHIBITOR OR A SGLT-2 INHIBITOR
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 140131950
Patent: PHARMACEUTICAL COMPOSITIONS COMPRISING METFORMIN AND A DPP-4 INHIBITOR OR A SGLT-2 INHIBITOR
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 1400144
Patent: Pharmaceutical composition and uses thereof
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 JENTADUETO XR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Slovenia | 2015754 | ⤷ Sign Up | |
| Taiwan | 201400144 | Pharmaceutical composition and uses thereof | ⤷ Sign Up |
| Australia | 2013229538 | Pharmaceutical compositions comprising metformin and a DPP-4 inhibitor or a SGLT-2 inhibitor | ⤷ Sign Up |
| Australia | 721477 | ⤷ Sign Up | |
| New Zealand | 555324 | Method for producing chiral 8-(3-amino-piperidin-1-yl)-xanthines | ⤷ Sign Up |
| Canada | 2412671 | COMPRIMES DESTINES A ACCROITRE LA RETENTION GASTRIQUE DE FORMES POSOLOGIQUES ORALES GONFLANTES A LIBERATION CONTROLEE (TABLET SHAPES TO ENHANCE GASTRIC RETENTION OF SWELLABLE CONTROLLED-RELEASE ORAL DOSAGE FORMS) | ⤷ Sign Up |
| Eurasian Patent Organization | 200702022 | 8-[3-АМИНОПИПЕРИДИН-1-ИЛ] КСАНТИНЫ, СПОСОБ ИХ ПОЛУЧЕНИЯ И ИХ ПРИМЕНЕНИЕ В КАЧЕСТВЕ ЛЕКАРСТВЕННЫХ СРЕДСТВ | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for JENTADUETO XR
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1084705 | PA2014042 | Lithuania | ⤷ Sign Up | PRODUCT NAME: VILDAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/414/001-010, 2007 09 26 EU/1/07/414/018 20070926 |
| 1532149 | 2011C/038 | Belgium | ⤷ Sign Up | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2--YLMETHYL)-3,7-DIHYDROPURIN-2,6-DIONE SES ENANTIOMERES OU L'UN DES SES SELS, EN PARTICULIER LA LINAGLIPTINE; AUTHORISATION NUMBER AND DATE: EU/1/11/707/001 20110830 |
| 1532149 | CA 2013 00001 | Denmark | ⤷ Sign Up | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720 |
| 1084705 | C300707 | Netherlands | ⤷ Sign Up | PRODUCT NAME: SAXAGLIPTIN; REGISTRATION NO/DATE: EU/1/09/545/001-010 20091001 |
| 1084705 | C01084705/02 | Switzerland | ⤷ Sign Up | PRODUCT NAME: VILDAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 57834 30.04.2008 |
| 1532149 | 92128 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE |
| 0896538 | 91334 | Luxembourg | ⤷ Sign Up | CERTIFICATE TITLE: SITAGLIPTIN, OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, EN PARTICULIER LE SEL PHOSPHATE (JANUVIA); FIRST REGISTRATION: 20070321 |
| >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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