Details for New Drug Application (NDA): 214154
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NDA 214154 describes NEXTSTELLIS, which is a drug marketed by Mayne Pharma and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the NEXTSTELLIS profile page.
The generic ingredient in NEXTSTELLIS is drospirenone; estetrol. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the drospirenone; estetrol profile page.
The generic ingredient in NEXTSTELLIS is drospirenone; estetrol. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the drospirenone; estetrol profile page.
Summary for 214154
| Tradename: | NEXTSTELLIS |
| Applicant: | Mayne Pharma |
| Ingredient: | drospirenone; estetrol |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214154
Generic Entry Date for 214154*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
TABLET;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.
Suppliers and Packaging for NDA: 214154
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154 | NDA | Mayne Pharma | 51862-258 | 51862-258-00 | 1 BLISTER PACK in 1 CARTON (51862-258-00) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04) |
| NEXTSTELLIS | drospirenone; estetrol | TABLET;ORAL | 214154 | NDA | Mayne Pharma | 51862-258 | 51862-258-01 | 1 BLISTER PACK in 1 CARTON (51862-258-01) / 1 KIT in 1 BLISTER PACK * 24 TABLET, FILM COATED in 1 BLISTER PACK (51862-259-24) * 4 TABLET, FILM COATED in 1 BLISTER PACK (51862-261-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 3MG;14.2MG | ||||
| Approval Date: | Apr 15, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 15, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 11,793,760 | Patent Expiration: | Jun 17, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,957,694 | Patent Expiration: | Jun 17, 2036 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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