Details for New Drug Application (NDA): 205832
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NDA 205832 describes OFEV, 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 OFEV profile page.
The generic ingredient in OFEV is nintedanib esylate. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nintedanib esylate profile page.
The generic ingredient in OFEV is nintedanib esylate. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nintedanib esylate profile page.
Summary for 205832
| Tradename: | OFEV |
| Applicant: | Boehringer Ingelheim |
| Ingredient: | nintedanib esylate |
| Patents: | 5 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205832
Generic Entry Date for 205832*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;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: 205832
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 205832
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OFEV | nintedanib esylate | CAPSULE;ORAL | 205832 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0143 | 0597-0143-60 | 1 BOTTLE in 1 CARTON (0597-0143-60) / 60 CAPSULE in 1 BOTTLE |
| OFEV | nintedanib esylate | CAPSULE;ORAL | 205832 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0145 | 0597-0145-60 | 1 BOTTLE in 1 CARTON (0597-0145-60) / 60 CAPSULE in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 100MG BASE | ||||
| Approval Date: | Oct 15, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 6, 2026 | ||||||||
| Regulatory Exclusivity Use: | INDICATED TO SLOW THE RATE OF DECLINE IN PULMONARY FUNCTION IN PATIENTS WITH SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD) | ||||||||
| Regulatory Exclusivity Expiration: | Mar 6, 2027 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 4, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 205832
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | OFEV | nintedanib esylate | CAPSULE;ORAL | 205832-001 | Oct 15, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | OFEV | nintedanib esylate | CAPSULE;ORAL | 205832-001 | Oct 15, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | OFEV | nintedanib esylate | CAPSULE;ORAL | 205832-002 | Oct 15, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Boehringer Ingelheim | OFEV | nintedanib esylate | CAPSULE;ORAL | 205832-002 | Oct 15, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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