Details for New Drug Application (NDA): 201280
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NDA 201280 describes TRADJENTA, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from three suppliers. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TRADJENTA profile page.
The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the linagliptin profile page.
The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the linagliptin profile page.
Summary for 201280
| Tradename: | TRADJENTA |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | linagliptin |
| Patents: | 8 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201280
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Medical Subject Heading (MeSH) Categories for 201280
Suppliers and Packaging for NDA: 201280
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRADJENTA | linagliptin | TABLET;ORAL | 201280 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0140 | 0597-0140-30 | 30 TABLET, FILM COATED in 1 BOTTLE (0597-0140-30) |
| TRADJENTA | linagliptin | TABLET;ORAL | 201280 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0140 | 0597-0140-61 | 100 BLISTER PACK in 1 CARTON (0597-0140-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | May 2, 2011 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Dec 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Jun 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1218-0091, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Feb 5, 2030 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 201280
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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