Details for New Drug Application (NDA): 202811
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NDA 202811 describes LINZESS, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are twelve patents protecting this drug and one Paragraph IV challenge. Additional details are available on the LINZESS profile page.
The generic ingredient in LINZESS is linaclotide. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linaclotide profile page.
The generic ingredient in LINZESS is linaclotide. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linaclotide profile page.
Summary for 202811
| Tradename: | LINZESS |
| Applicant: | Allergan |
| Ingredient: | linaclotide |
| Patents: | 12 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202811
| Mechanism of Action | Guanylate Cyclase Activators |
Suppliers and Packaging for NDA: 202811
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LINZESS | linaclotide | CAPSULE;ORAL | 202811 | NDA | Allergan, Inc. | 0456-1201 | 0456-1201-04 | 1 BOTTLE in 1 CARTON (0456-1201-04) / 4 CAPSULE, GELATIN COATED in 1 BOTTLE |
| LINZESS | linaclotide | CAPSULE;ORAL | 202811 | NDA | Allergan, Inc. | 0456-1201 | 0456-1201-30 | 1 BOTTLE in 1 CARTON (0456-1201-30) / 30 CAPSULE, GELATIN COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 145MCG | ||||
| Approval Date: | Aug 30, 2012 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 30, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS. | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 30, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 28, 2024 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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