Details for New Drug Application (NDA): 201292
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NDA 201292 describes GILOTRIF, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the GILOTRIF profile page.
The generic ingredient in GILOTRIF is afatinib dimaleate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the afatinib dimaleate profile page.
The generic ingredient in GILOTRIF is afatinib dimaleate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the afatinib dimaleate profile page.
Summary for 201292
| Tradename: | GILOTRIF |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | afatinib dimaleate |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 201292
Generic Entry Date for 201292*:
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: 201292
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 201292
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0137 | 0597-0137-30 | 1 BOTTLE in 1 CARTON (0597-0137-30) / 30 TABLET, FILM COATED in 1 BOTTLE |
| GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0137 | 0597-0137-90 | 1 BOTTLE in 1 CARTON (0597-0137-90) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Jul 12, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 12, 2025 | ||||||||
| Regulatory Exclusivity Use: | FIRST-LINE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR (EGFR) MUTATIONS OTHER THAN EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST | ||||||||
| Regulatory Exclusivity Expiration: | Jul 12, 2025 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Oct 7, 2025 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
Expired US Patents for NDA 201292
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-003 | Jul 12, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-001 | Jul 12, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-002 | Jul 12, 2013 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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