DrugPatentWatch Database Preview
ADDYI Drug Profile
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When do Addyi patents expire, and what generic alternatives are available?
Addyi is a drug marketed by Sprout Pharms and is included in one NDA. There are four patents protecting this drug.
This drug has eighty-two patent family members in thirty-one countries.
The generic ingredient in ADDYI is flibanserin. One supplier is listed for this compound. Additional details are available on the flibanserin profile page.
US ANDA Litigation and Generic Entry Outlook for Addyi
Addyi was eligible for patent challenges on August 18, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be August 1, 2022. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for ADDYI
| International Patents: | 82 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 52 |
| Patent Applications: | 273 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ADDYI |
| DailyMed Link: | ADDYI at DailyMed |
Generic Entry Opportunity Date for ADDYI
Generic Entry Date for ADDYI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;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 ADDYI
| Mechanism of Action | P-Glycoprotein Inhibitors |
US Patents and Regulatory Information for ADDYI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | 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 ADDYI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Ukraine | 78974 | Start Trial |
| China | 102125557 | Start Trial |
| Spain | 2237694 | Start Trial |
| Israel | 159151 | Start Trial |
| South Africa | 200309586 | Start Trial |
| Ecuador | SP045069 | Start Trial |
| Colombia | 5560572 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
