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Linagliptin - Generic Drug Details
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What are the generic sources for linagliptin and what is the scope of linagliptin patent protection?
Linagliptin
is the generic ingredient in three branded drugs marketed by Boehringer Ingelheim and is included in three NDAs. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Linagliptin has three hundred and one patent family members in forty-four countries.
There are nineteen drug master file entries for linagliptin. Two suppliers are listed for this compound.
Summary for linagliptin
| International Patents: | 301 |
| US Patents: | 16 |
| Tradenames: | 3 |
| Applicants: | 1 |
| NDAs: | 3 |
| Drug Master File Entries: | 19 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 65 |
| Clinical Trials: | 112 |
| Patent Applications: | 477 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for linagliptin |
| DailyMed Link: | linagliptin at DailyMed |
Pharmacology for linagliptin
| Drug Class | Dipeptidyl Peptidase 4 Inhibitor |
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Medical Subject Heading (MeSH) Categories for linagliptin
Synonyms for linagliptin
| (R)-8-(3-Amino-piperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methyl-quinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione |
| (R)-8-(3-aminopiperidin-1-yl)-7-(but-2-yn-1-yl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-3,7-dihydro-1H-purine-2,6-dione |
| (R)-8-(3-aminopiperidin-1-yl)-7-(but-2-ynyl)-3-methyl-1-((4-methylquinazolin-2-yl)methyl)-1H-purine-2,6(3H,7H)-dione |
| (R)-8-(3-aminopiperidin-1-yl)-7-but-2-ynyl-3-methyl-1-(4-methylquinazolin-2-ylmethyl)-3,7-dihydro-purine-2,6-dione |
| 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)-aminopiperidin-1-yl)xanthine |
| 1-[(4-methyl-quinazolin-2-yl)methyl]-3-methyl-7-(2-butyn-1-yl)-8-(3-(R)aminopiperidin-1-yl)xanthine |
| 1-[(4-methyl-quinazolin-2yl) methyl]-3-methyl-7-(2-butyn-1-yl)-8-[3-(R) amino-piperidin-1-yl]-xanthine |
| 1-[(4-Methylquinazolin-2-yl)-methyl]-3-methyl-7-(2-butin-1-yl)-8-(3-(R)-aminopiperidin-1-yl)-xanthine |
| 1-[(4-Methylquinazolin-2-yl)methyl]-3-methyl-7-(2-butin-1-yl)-8-(3-(R)-aminopiperidin-1-yl)-xanthine |
| 1h-purine-2,6-dione, 8-[(3r)-3-amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]- |
| 270L120 |
| 3X29ZEJ4R2 |
| 668270-12-0 |
| 8-[(3R)-3-Amino-1-piperidinyl]-7-(2-butyn-1-yl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-1H-purine-2,6-dione |
| 8-[(3R)-3-Amino-1-piperidinyl]-7-(2-butynyl)-3,7-dihydro-3-methyl-1-[(4-methyl-2-quinazolinyl)methyl]-1H-purine-2,6-dione |
| 8-[(3R)-3-amino-1-piperidyl]-7-but-2-ynyl-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione |
| 8-[(3R)-3-aminopiperidin-1-yl]-7-(but-2-yn-1-yl)-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]-3,7-dihydro-1H-purine-2,6-dione |
| 8-[(3r)-3-Aminopiperidin-1-Yl]-7-But-2-Yn-1-Yl-3-Methyl-1-[(4-Methylquinazolin-2-Yl)methyl]-3,7-Dihydro-1h-Purine-2,6-Dione |
| 8-[(3R)-3-aminopiperidin-1-yl]-7-but-2-ynyl-3-methyl-1-[(4-methylquinazolin-2-yl)methyl]purine-2,6-dione |
| AB0008009 |
| AB01563307_01 |
| AB01563307_03 |
| AB1008521 |
| AC-8761 |
| ACN-028592 |
| AJ-45731 |
| AK134946 |
| AKOS015951179 |
| AKOS015995251 |
| AN-2539 |
| API0007204 |
| AX8161416 |
| BCP9000854 |
| BCPP000185 |
| BDBM50228403 |
| BI 1356 |
| BI 1356BS |
| BI-1356 |
| BI-1356-BS |
| BS 1356 BS |
| BS-1356-BS |
| C25H28N8O2 |
| CHEBI:68610 |
| CHEMBL237500 |
| CS-0637 |
| D02EYG |
| D09566 |
| DB08882 |
| EX-A076 |
| FT-0670793 |
| GP5216 |
| GTPL6318 |
| HY-10284 |
| J-519354 |
| KB-78157 |
| KS-00000765 |
| Linagliptin (BI-1356) |
| Linagliptin (JAN/USAN/INN) |
| Linagliptin [USAN:INN:JAN] |
| Linagliptin S-Isomer |
| LTXREWYXXSTFRX-QGZVFWFLSA-N |
| MLS006010217 |
| MolPort-021-783-260 |
| NCGC00346655-01 |
| Ondero |
| Ondero (TN) |
| Q-4491 |
| RL04547 |
| s3031 |
| SC-66358 |
| SC-83230 |
| SCHEMBL160188 |
| SMR004701306 |
| Tradjenta |
| Tradjenta (TN) |
| Trajenta |
| Trazenta |
| UNII-3X29ZEJ4R2 |
| X1062 |
| ZINC3820029 |
US Patents and Regulatory Information for linagliptin
| 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 | 208026-002 | 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 | 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 | 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 |
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Expired US Patents for linagliptin
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for linagliptin
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 6,803,357 | Method of regulating glucose metabolism, and reagents related thereto | ➤ Sign Up |
| 7,157,429 | Method of regulating glucose metabolism, and reagents related thereto | ➤ Sign Up |
| 7,829,530 | Method of regulating glucose metabolism, and reagents related thereto | ➤ Sign Up |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for linagliptin
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Japan | 2016199572 | ➤ Sign Up |
| South Korea | 101806786 | ➤ Sign Up |
| China | 103351388 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for linagliptin
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0872 | Netherlands | ➤ Sign Up | PRODUCT NAME: COMBINATIE VAN EMPAGLIFLOZINE EN LINAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/16/1146 20161115 |
| 1084705/04 | Switzerland | ➤ Sign Up | PRODUCT NAME: LINAGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 61893 08.03.2012 |
| 2017 00019 | Denmark | ➤ Sign Up | PRODUCT NAME: KOMBINATION AF EMPAGLIFLOZIN OG LINAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/16/1146/001-018 20161115 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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