Details for New Drug Application (NDA): 022287
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NDA 022287 describes DEXILANT, which is a drug marketed by Takeda Pharms Usa and is included in two NDAs. It is available from four suppliers. There are twelve patents protecting this drug and two Paragraph IV challenges. Additional details are available on the DEXILANT profile page.
The generic ingredient in DEXILANT is dexlansoprazole. There are seventeen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.
The generic ingredient in DEXILANT is dexlansoprazole. There are seventeen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dexlansoprazole profile page.
Summary for 022287
| Tradename: | DEXILANT |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | dexlansoprazole |
| Patents: | 10 |
Pharmacology for NDA: 022287
| Mechanism of Action | Proton Pump Inhibitors |
Medical Subject Heading (MeSH) Categories for 022287
Suppliers and Packaging for NDA: 022287
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287 | NDA AUTHORIZED GENERIC | TWI PHARMACEUTICALS, INC. | 24979-703 | 24979-703-06 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24979-703-06) |
| DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287 | NDA AUTHORIZED GENERIC | TWI PHARMACEUTICALS, INC. | 24979-704 | 24979-704-06 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (24979-704-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED RELEASE;ORAL | Strength | 30MG | ||||
| Approval Date: | Jan 30, 2009 | TE: | AB | RLD: | Yes | ||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Feb 2, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Mar 27, 2027 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Sep 17, 2030 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 022287
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-002 | Jan 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-001 | Jan 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-002 | Jan 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-002 | Jan 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-002 | Jan 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Takeda Pharms Usa | DEXILANT | dexlansoprazole | CAPSULE, DELAYED RELEASE;ORAL | 022287-001 | Jan 30, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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