Details for New Drug Application (NDA): 218201
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NDA 218201 describes MIUDELLA, which is a drug marketed by Sebela Womens Hlth and is included in one NDA. It is available from one supplier. There are thirteen patents protecting this drug. Additional details are available on the MIUDELLA profile page.
The generic ingredient in MIUDELLA is copper. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the copper profile page.
The generic ingredient in MIUDELLA is copper. There are fifteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the copper profile page.
Summary for 218201
| Tradename: | MIUDELLA |
| Applicant: | Sebela Womens Hlth |
| Ingredient: | copper |
| Patents: | 13 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218201
Generic Entry Date for 218201*:
Constraining patent/regulatory exclusivity:
NEW PRODUCT Dosage:
SYSTEM;INTRAUTERINE |
*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: 218201
| Physiological Effect | Decreased Embryonic Implantation Decreased Sperm Motility Inhibit Ovum Fertilization |
Medical Subject Heading (MeSH) Categories for 218201
Suppliers and Packaging for NDA: 218201
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MIUDELLA | copper | SYSTEM;INTRAUTERINE | 218201 | NDA | Sebela Women's Health Inc. | 82686-300 | 82686-300-01 | 1 TRAY in 1 BOX, UNIT-DOSE (82686-300-01) / 1 INTRAUTERINE DEVICE in 1 TRAY |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYSTEM;INTRAUTERINE | Strength | N/A | ||||
| Approval Date: | Feb 24, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 24, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Mar 22, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Get Started Free | Patent Expiration: | Aug 14, 2032 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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