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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 two suppliers. There are sixteen 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. Two 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. Two 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: | 16 |
Generic Entry Opportunity Date for 021908
Generic Entry Date for 021908*:
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: 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 | Lake Erie Medical DBA Quality Care Products LLC | 35356-500 | 35356-500-60 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (35356-500-60) |
| AMITIZA | lubiprostone | CAPSULE;ORAL | 021908 | NDA | Takeda Pharmaceuticals America, Inc. | 64764-080 | 64764-080-60 | 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64764-080-60) |
Paragraph IV (Patent) Challenges for 021908
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AMITIZA | CAPSULE;ORAL | lubiprostone | 021908 | 2012-08-20 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 24MCG | ||||
| Approval Date: | Jan 31, 2006 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 26, 2021 | ||||||||
| Regulatory Exclusivity Use: | REVISIONS TO SECTION 8.4 OF THE PRESCRIBING INFORMATION TO INCLUDE A SAFETY AND EFFICACY STUDY IN PEDIATRIC PATIENTS AGES >=6 YEARS TO | ||||||||
| Patent: | Start Trial | Patent Expiration: | Sep 5, 2020 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT | ||||||||
| Patent: | Start Trial | Patent Expiration: | Sep 5, 2020 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN PATIENT WITH OPIOID-INDUCED CONSTIPATION | ||||||||
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 | 021908-002 | Apr 29, 2008 | Start Trial | Start Trial |
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | Start Trial | Start Trial |
| Sucampo Pharma Llc | AMITIZA | lubiprostone | CAPSULE;ORAL | 021908-001 | Jan 31, 2006 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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