Details for New Drug Application (NDA): 205598
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The generic ingredient in MACRILEN is macimorelin acetate. One supplier is listed for this compound. Additional details are available on the macimorelin acetate profile page.
Summary for 205598
Tradename: | MACRILEN |
Applicant: | Novo |
Ingredient: | macimorelin acetate |
Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 205598
Generic Entry Date for 205598*:
Constraining patent/regulatory exclusivity:
FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD) Dosage:
FOR SOLUTION;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: 205598
Mechanism of Action | Growth Hormone Secretagogue Receptor Agonists |
Suppliers and Packaging for NDA: 205598
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
MACRILEN | macimorelin acetate | FOR SOLUTION;ORAL | 205598 | NDA | Novo Nordisk | 0169-1401 | 0169-1401-01 | 1 POUCH in 1 CARTON (0169-1401-01) / 60 mg in 1 POUCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 60MG BASE/POUCH | ||||
Approval Date: | Dec 20, 2017 | TE: | RLD: | Yes | |||||
Regulatory Exclusivity Expiration: | Dec 20, 2024 | ||||||||
Regulatory Exclusivity Use: | FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY (AGHD) | ||||||||
Patent: | ⤷ Sign Up | Patent Expiration: | Oct 12, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | A METHOD FOR THE DIAGNOSIS OF ADULT GROWTH HORMONE DEFICIENCY BY MEASURING THE LEVEL OF GROWTH HORMONE AFTER ORAL ADMINISTRATION OF MACIMORELIN |
Expired US Patents for NDA 205598
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novo | MACRILEN | macimorelin acetate | FOR SOLUTION;ORAL | 205598-001 | Dec 20, 2017 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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