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VYLEESI (AUTOINJECTOR) Drug Profile
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» See Plans and PricingWhich patents cover Vyleesi (autoinjector), and what generic alternatives are available?
Vyleesi (autoinjector) is a drug marketed by Amag Pharms Inc and is included in one NDA. There are five patents protecting this drug.
This drug has seventy-seven patent family members in twenty-four countries.
The generic ingredient in VYLEESI (AUTOINJECTOR) is bremelanotide acetate. One supplier is listed for this compound. Additional details are available on the bremelanotide acetate profile page.
US ANDA Litigation and Generic Entry Outlook for Vyleesi (autoinjector)
Vyleesi (autoinjector) will be eligible for patent challenges on June 21, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be June 21, 2024. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for VYLEESI (AUTOINJECTOR)
| International Patents: | 77 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VYLEESI (AUTOINJECTOR) |
| DailyMed Link: | VYLEESI (AUTOINJECTOR) at DailyMed |
-patent-expirations.png "VYLEESI (AUTOINJECTOR) drug patent expirations")
Generic Entry Opportunity Date for VYLEESI (AUTOINJECTOR)
Generic Entry Date for VYLEESI (AUTOINJECTOR)*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY NDA:
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.
US Patents and Regulatory Information for VYLEESI (AUTOINJECTOR)
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amag Pharms Inc | VYLEESI (AUTOINJECTOR) | bremelanotide acetate | SOLUTION;SUBCUTANEOUS | 210557-001 | Jun 21, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Amag Pharms Inc | VYLEESI (AUTOINJECTOR) | bremelanotide acetate | SOLUTION;SUBCUTANEOUS | 210557-001 | Jun 21, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Amag Pharms Inc | VYLEESI (AUTOINJECTOR) | bremelanotide acetate | SOLUTION;SUBCUTANEOUS | 210557-001 | Jun 21, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for VYLEESI (AUTOINJECTOR)
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Israel | 238276 | Start Trial |
| Georgia, Republic of | P20196947 | Start Trial |
| Japan | 6567971 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
