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 two suppliers. There are ten 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. Two 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. Two 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: | 10 |
| 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: | Mar 30, 2023 | ||||||||
| Regulatory Exclusivity Use: | ADDITION OF INFORMATION TO CLINICAL STUDIES SECTION REGARDING CARDIOVASCULAR OUTCOME | ||||||||
| Regulatory Exclusivity Expiration: | Jul 3, 2022 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE LABELING TO DESCRIBE CARMELINA TRIAL TO FULFILL POSTMARKETING COMMITMENT 1766-4 | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Aug 5, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT WITH RENAL IMPAIRMENT AND FOR WHOM METFORMIN THERAPY IS INAPPROPRIATE BY ADMINISTERING LINAGLIPTIN WITHOUT DOSE ADJUSTMENT | ||||||||
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 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | See Plans and Pricing | See Plans and Pricing |
| Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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