LINAGLIPTIN; METFORMIN HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for linagliptin; metformin hydrochloride and what is the scope of freedom to operate?
Linagliptin; metformin hydrochloride
is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim, Sunshine, and Zydus Pharms, and is included in four NDAs. There are eleven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Linagliptin; metformin hydrochloride has three hundred and eighty-nine patent family members in forty-five countries.
One supplier is listed for this compound. There are two tentative approvals for this compound.
Summary for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
International Patents: | 389 |
US Patents: | 11 |
Tradenames: | 3 |
Applicants: | 3 |
NDAs: | 4 |
Finished Product Suppliers / Packagers: | 1 |
Clinical Trials: | 61 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LINAGLIPTIN; METFORMIN HYDROCHLORIDE |
DailyMed Link: | LINAGLIPTIN; METFORMIN HYDROCHLORIDE at DailyMed |
Recent Clinical Trials for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Medanta, The Medicity, India | N/A |
Dong Wha Pharmaceutical Co. Ltd. | Phase 1 |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | N/A |
See all LINAGLIPTIN; METFORMIN HYDROCHLORIDE clinical trials
Generic filers with tentative approvals for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 2.5MG; 1G | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 2.5MG; 850MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 2.5MG; 500MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Drug Class | Biguanide Dipeptidyl Peptidase 4 Inhibitor |
Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
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 |
JENTADUETO | Tablets | linagliptin; metformin hydrochloride | 2.5 mg/500 mg 2.5 mg/850 mg 2.5 mg/1000 mg | 201281 | 8 | 2015-05-04 |
US Patents and Regulatory Information for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
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 | linagliptin; metformin hydrochloride | TABLET;ORAL | 201281-001 | Jan 30, 2012 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Boehringer Ingelheim | JENTADUETO | linagliptin; metformin hydrochloride | TABLET;ORAL | 201281-001 | Jan 30, 2012 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Boehringer Ingelheim | JENTADUETO | linagliptin; metformin hydrochloride | TABLET;ORAL | 201281-002 | Jan 30, 2012 | 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 |
Expired US Patents for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Boehringer Ingelheim | JENTADUETO | linagliptin; metformin hydrochloride | TABLET;ORAL | 201281-003 | Jan 30, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | JENTADUETO | linagliptin; metformin hydrochloride | TABLET;ORAL | 201281-002 | Jan 30, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | JENTADUETO | linagliptin; metformin hydrochloride | TABLET;ORAL | 201281-003 | Jan 30, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Boehringer Ingelheim | JENTADUETO | linagliptin; metformin hydrochloride | TABLET;ORAL | 201281-001 | Jan 30, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
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 LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Eurasian Patent Organization | 036618 | СПОСОБ ТЕРАПЕВТИЧЕСКОГО ЛЕЧЕНИЯ ВЫРАЖЕННОГО ДИАБЕТА 2 ТИПА С ПОМОЩЬЮ ИНГИБИТОРА DPP IV (METHOD OF THERAPEUTIC TREATMENT OF MANIFEST TYPE 2 DIABETES USING DPP IV INHIBITOR) | ⤷ Sign Up |
Taiwan | I520738 | ⤷ Sign Up | |
Japan | 6139004 | ⤷ Sign Up | |
Taiwan | 200944209 | 8-[3-amino-piperidin-1-yl]-xanthines, the preparation thereof and their use as pharmaceutical compositions | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LINAGLIPTIN; METFORMIN HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1532149 | PA2012022 | Lithuania | ⤷ Sign Up | PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720 |
1532149 | C300569 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720 |
1532149 | CA 2011 00030 | Denmark | ⤷ Sign Up | |
1532149 | 11C0052 | France | ⤷ Sign Up | PRODUCT NAME: LINAGLIPTINE SES ENANTIOMERES ET SELS; REGISTRATION NO/DATE: EU/1/11/707/001 20110830 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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