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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 nine 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: | 9 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 201280
Generic Entry Date for 201280*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 |
Paragraph IV (Patent) Challenges for 201280
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| TRADJENTA | TABLET;ORAL | linagliptin | 201280 | 2015-05-04 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | May 2, 2011 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jul 3, 2022 | ||||||||
| Regulatory Exclusivity Use: | |||||||||
| Regulatory Exclusivity Expiration: | Mar 30, 2023 | ||||||||
| Regulatory Exclusivity Use: | |||||||||
| Patent: | Start Trial | Patent Expiration: | Aug 5, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
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 | Start Trial | Start Trial |
| Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | Start Trial | Start Trial |
| Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | Start Trial | Start Trial |
| Boehringer Ingelheim | TRADJENTA | linagliptin | TABLET;ORAL | 201280-001 | May 2, 2011 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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