Details for New Drug Application (NDA): 209363
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NDA 209363 describes SOLOSEC, which is a drug marketed by Evofem Inc and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the SOLOSEC profile page.
The generic ingredient in SOLOSEC is secnidazole. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the secnidazole profile page.
The generic ingredient in SOLOSEC is secnidazole. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the secnidazole profile page.
Summary for 209363
| Tradename: | SOLOSEC |
| Applicant: | Evofem Inc |
| Ingredient: | secnidazole |
| Patents: | 10 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209363
Generic Entry Date for 209363*:
Constraining patent/regulatory exclusivity:
Dosage:
GRANULE;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: 209363
Suppliers and Packaging for NDA: 209363
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SOLOSEC | secnidazole | GRANULE;ORAL | 209363 | NDA | Lupin Pharmaceuticals, Inc. | 27437-051 | 27437-051-01 | 1 PACKET in 1 BOX, UNIT-DOSE (27437-051-01) / 2 g in 1 PACKET |
| SOLOSEC | secnidazole | GRANULE;ORAL | 209363 | NDA | Lupin Pharmaceuticals, Inc. | 27437-051 | 27437-051-02 | 1 PACKET in 1 BOX, UNIT-DOSE (27437-051-02) / 2 g in 1 PACKET |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 2GM/PACKET | ||||
| Approval Date: | Sep 15, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 30, 2024 | ||||||||
| Regulatory Exclusivity Use: | FOR THE TREATMENT OF TRICHOMONIASIS CAUSED BY TRICHOMONAS VAGINALIS IN ADULTS | ||||||||
| Regulatory Exclusivity Expiration: | Sep 15, 2027 | ||||||||
| Regulatory Exclusivity Use: | GENERATING ANTIBIOTIC INCENTIVES NOW | ||||||||
| Regulatory Exclusivity Expiration: | Sep 15, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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