ADDYI Drug Patent Profile
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Which patents cover Addyi, and when can generic versions of Addyi launch?
Addyi is a drug marketed by Sprout Pharms and is included in one NDA. There is one patent protecting this drug.
This drug has forty-two patent family members in twenty-nine countries.
The generic ingredient in ADDYI is flibanserin. One supplier is listed for this compound. Additional details are available on the flibanserin profile page.
DrugPatentWatch® 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 May 9, 2028. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for ADDYI?
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Summary for ADDYI
International Patents: | 42 |
US Patents: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 74 |
Patent Applications: | 556 |
Drug Prices: | Drug price information for ADDYI |
What excipients (inactive ingredients) are in ADDYI? | ADDYI excipients list |
DailyMed Link: | ADDYI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
ADDYI is protected by one US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ADDYI is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ADDYI
Method of treating female hypoactive sexual desire disorder with flibanserin
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE OF FLIBANSERIN OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF TO TREAT HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ADDYI
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | ⤷ Sign Up | ⤷ Sign Up |
Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ADDYI
See the table below for patents covering ADDYI around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Africa | 200309586 | STABLE POLYMORPH OF FLIBANSERIN TECHNICAL PROCESS FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS | ⤷ Sign Up |
Denmark | 1446122 | ⤷ Sign Up | |
World Intellectual Property Organization (WIPO) | 03035072 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |