Details for New Drug Application (NDA): 021908
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NDA 021908 describes AMITIZA, which is a drug marketed by Sucampo Pharma Llc and is included in one NDA. It is available from ten suppliers. There are five patents protecting this drug and one Paragraph IV challenge. Additional details are available on the AMITIZA profile page.
The generic ingredient in AMITIZA is lubiprostone. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.
The generic ingredient in AMITIZA is lubiprostone. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.
Summary for 021908
| Tradename: | AMITIZA |
| Applicant: | Sucampo Pharma Llc |
| Ingredient: | lubiprostone |
| Patents: | 5 |
Pharmacology for NDA: 021908
| Mechanism of Action | Chloride Channel Activators |
Medical Subject Heading (MeSH) Categories for 021908
Suppliers and Packaging for NDA: 021908
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMITIZA | lubiprostone | CAPSULE;ORAL | 021908 | NDA AUTHORIZED GENERIC | Endo USA, Inc. | 0254-3028 | 0254-3028-02 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0254-3028-02) |
| AMITIZA | lubiprostone | CAPSULE;ORAL | 021908 | NDA AUTHORIZED GENERIC | Endo USA, Inc. | 0254-3029 | 0254-3029-02 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0254-3029-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 24MCG | ||||
| Approval Date: | Jan 31, 2006 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Oct 25, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jan 23, 2027 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 1, 2025 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT | ||||||||
Expired US Patents for NDA 021908
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | ⤷ Sign Up | ⤷ Sign Up |
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-002 | Apr 29, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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