Details for New Drug Application (NDA): 022512
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NDA 022512 describes PRADAXA, which is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from four suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the PRADAXA profile page.
The generic ingredient in PRADAXA is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
The generic ingredient in PRADAXA is dabigatran etexilate mesylate. There are twenty-six drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the dabigatran etexilate mesylate profile page.
Summary for 022512
| Tradename: | PRADAXA |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | dabigatran etexilate mesylate |
| Patents: | 2 |
Pharmacology for NDA: 022512
| Mechanism of Action | Thrombin Inhibitors |
Medical Subject Heading (MeSH) Categories for 022512
Suppliers and Packaging for NDA: 022512
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512 | NDA | Boehringer Ingelheim Pharmaceuticals Inc. | 0597-0108 | 0597-0108-54 | 1 BOTTLE in 1 CARTON (0597-0108-54) / 60 CAPSULE in 1 BOTTLE |
| PRADAXA | dabigatran etexilate mesylate | CAPSULE;ORAL | 022512 | NDA | Boehringer Ingelheim Pharmaceuticals Inc. | 0597-0108 | 0597-0108-60 | 10 BLISTER PACK in 1 CARTON (0597-0108-60) / 6 CAPSULE in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 75MG BASE | ||||
| Approval Date: | Oct 19, 2010 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Dec 21, 2024 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Jun 21, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF VENOUS THROMBOEMBOLIC EVENTS (VTE) IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR AT LEAST 5 DAYS AND TO REDUCE THE RISK OF RECURRENCE OF VTE IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN PREVIOUSLY TREATED | ||||||||
| Patent: | 7,932,273*PED | Patent Expiration: | Mar 7, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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