Details for New Drug Application (NDA): 022580
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NDA 022580 describes QSYMIA, which is a drug marketed by Vivus Llc and is included in one NDA. It is available from one supplier. There are six patents protecting this drug and one Paragraph IV challenge. Additional details are available on the QSYMIA profile page.
The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.
The generic ingredient in QSYMIA is phentermine hydrochloride; topiramate. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the phentermine hydrochloride; topiramate profile page.
Summary for 022580
| Tradename: | QSYMIA |
| Applicant: | Vivus Llc |
| Ingredient: | phentermine hydrochloride; topiramate |
| Patents: | 6 |
Suppliers and Packaging for NDA: 022580
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580 | NDA | Vivus LLC | 62541-201 | 62541-201-14 | 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-14) |
| QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580 | NDA | Vivus LLC | 62541-201 | 62541-201-30 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, UNIT-DOSE (62541-201-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 3.75MG BASE;23MG | ||||
| Approval Date: | Jul 17, 2012 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Sep 13, 2027 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE LABELING TO DESCRIBE A CLINICAL STUDY | ||||||||
| Regulatory Exclusivity Expiration: | Jun 24, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | ⤷ Subscribe | Patent Expiration: | May 15, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022580
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Vivus Llc | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-002 | Jul 17, 2012 | ⤷ Subscribe | ⤷ Subscribe |
| Vivus Llc | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-002 | Jul 17, 2012 | ⤷ Subscribe | ⤷ Subscribe |
| Vivus Llc | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | ⤷ Subscribe | ⤷ Subscribe |
| Vivus Llc | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-003 | Jul 17, 2012 | ⤷ Subscribe | ⤷ Subscribe |
| Vivus Llc | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | ⤷ Subscribe | ⤷ Subscribe |
| Vivus Llc | QSYMIA | phentermine hydrochloride; topiramate | CAPSULE, EXTENDED RELEASE;ORAL | 022580-004 | Jul 17, 2012 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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