Details for New Drug Application (NDA): 219469
✉ Email this page to a colleague
NDA 219469 describes LYNKUET, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the LYNKUET profile page.
The generic ingredient in LYNKUET is elinzanetant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the elinzanetant profile page.
The generic ingredient in LYNKUET is elinzanetant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the elinzanetant profile page.
Summary for 219469
| Tradename: | LYNKUET |
| Applicant: | Bayer Hlthcare |
| Ingredient: | elinzanetant |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219469
Generic Entry Date for 219469*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
CAPSULE;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: 219469
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LYNKUET | elinzanetant | CAPSULE;ORAL | 219469 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-475 | 50419-475-05 | 5 BLISTER PACK in 1 CARTON (50419-475-05) / 12 CAPSULE in 1 BLISTER PACK (50419-475-01) |
| LYNKUET | elinzanetant | CAPSULE;ORAL | 219469 | NDA | Bayer HealthCare Pharmaceuticals Inc. | 50419-475 | 50419-475-72 | 2 BLISTER PACK in 1 CARTON (50419-475-72) / 12 CAPSULE in 1 BLISTER PACK (50419-475-71) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 60MG | ||||
| Approval Date: | Oct 24, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 24, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,195,205 | Patent Expiration: | May 18, 2036 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS DUE TO MENOPAUSE | ||||||||
| Patent: | 10,774,091 | Patent Expiration: | Mar 13, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Complete Access Available with Subscription
