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 three suppliers. There are nine 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. Four 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. Four 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: | 9 |
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 | Par Pharmaceutical Inc. | 0254-3028 | 0254-3028-02 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (0254-3028-02) |
| AMITIZA | lubiprostone | CAPSULE;ORAL | 021908 | NDA AUTHORIZED GENERIC | Par Pharmaceutical 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: | See Plans and Pricing | Patent Expiration: | Dec 4, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR TREATING OPIOID-INDUCED CONSTIPATION | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Aug 30, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR TREATING CONSTIPATION BY OPENING CIC CHANNELS IN A MAMMALIAN SUBJECT | ||||||||
| Patent: | See Plans and Pricing | Patent Expiration: | Aug 30, 2022 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR TREATING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION BY OPENING CIC CHANNELS | ||||||||
Expired US Patents for NDA 021908
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