Details for New Drug Application (NDA): 210557
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NDA 210557 describes VYLEESI (AUTOINJECTOR), which is a drug marketed by Cosette 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 VYLEESI (AUTOINJECTOR) profile page.
The generic ingredient in VYLEESI (AUTOINJECTOR) is bremelanotide acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the bremelanotide acetate profile page.
The generic ingredient in VYLEESI (AUTOINJECTOR) is bremelanotide acetate. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the bremelanotide acetate profile page.
Summary for 210557
| Tradename: | VYLEESI (AUTOINJECTOR) |
| Applicant: | Cosette |
| Ingredient: | bremelanotide acetate |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 210557
Generic Entry Date for 210557*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS |
*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: 210557
| Mechanism of Action | Melanocortin Receptor Agonists |
Suppliers and Packaging for NDA: 210557
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VYLEESI (AUTOINJECTOR) | bremelanotide acetate | SOLUTION;SUBCUTANEOUS | 210557 | NDA | Cosette Pharmaceuticals, Inc. | 0713-0897 | 0713-0897-04 | 4 SYRINGE in 1 CARTON (0713-0897-04) / .3 mL in 1 SYRINGE (0713-0897-06) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML) | ||||
| Approval Date: | Jun 21, 2019 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 5, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD) | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Apr 29, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATING ACQUIRED, GENERALIZED HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD) IN A PREMENOPAUSAL FEMALE PATIENT WITH CONTROLLED HYPERTENSION BY INJECTING BREMELANOTIDE MORE THAN ONCE WITH AT LEAST 24 HOURS BETWEEN DOSES AND NO MORE THAN 8 DOSES PER MONTH | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Nov 5, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD) | ||||||||
Expired US Patents for NDA 210557
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Cosette | VYLEESI (AUTOINJECTOR) | bremelanotide acetate | SOLUTION;SUBCUTANEOUS | 210557-001 | Jun 21, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| Cosette | VYLEESI (AUTOINJECTOR) | bremelanotide acetate | SOLUTION;SUBCUTANEOUS | 210557-001 | Jun 21, 2019 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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