Details for New Drug Application (NDA): 201281
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NDA 201281 describes JENTADUETO, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from one supplier. There are eleven patents protecting this drug and two Paragraph IV challenges. Additional details are available on the JENTADUETO profile page.
The generic ingredient in JENTADUETO is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.
The generic ingredient in JENTADUETO is linagliptin; metformin hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linagliptin; metformin hydrochloride profile page.
Summary for 201281
| Tradename: | JENTADUETO |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | linagliptin; metformin hydrochloride |
| Patents: | 9 |
Pharmacology for NDA: 201281
| Mechanism of Action | Dipeptidyl Peptidase 4 Inhibitors |
Suppliers and Packaging for NDA: 201281
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| JENTADUETO | linagliptin; metformin hydrochloride | TABLET;ORAL | 201281 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0146 | 0597-0146-18 | 180 TABLET, FILM COATED in 1 BOTTLE (0597-0146-18) |
| JENTADUETO | linagliptin; metformin hydrochloride | TABLET;ORAL | 201281 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0146 | 0597-0146-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0597-0146-60) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG;500MG | ||||
| Approval Date: | Jan 30, 2012 | 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: | ⤷ Sign Up | Patent Expiration: | Oct 2, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 201281
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| 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 | 201281-001 | Jan 30, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | JENTADUETO | linagliptin; metformin hydrochloride | TABLET;ORAL | 201281-002 | Jan 30, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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