ADDYI Drug Patent 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.
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 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 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 61 |
| Patent Applications: | 308 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ADDYI |
| What excipients (inactive ingredients) are in ADDYI? | ADDYI excipients list |
| DailyMed Link: | ADDYI at DailyMed |
DrugPatentWatch® Estimated 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 |
Anatomical Therapeutic Chemical (ATC) Classes for ADDYI
US Patents and Regulatory Information for ADDYI
ADDYI is protected by four US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ADDYI is See Plans and Pricing.
This potential generic entry date is based on patent See Plans and Pricing.
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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF FLIBANSERIN OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF TO TREAT HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)
Stable polymorph of flibanserin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Treating sexual desire disorders with flibanserin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: USE OF FLIBANSERIN OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF TO TREAT HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)
Treating sexual desire disorders with flibanserin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Sprout Pharms | ADDYI | flibanserin | TABLET;ORAL | 022526-001 | Aug 18, 2015 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >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
See the table below for patents covering ADDYI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Korea | 20040023704 | See Plans and Pricing | |
| South Korea | 20110132479 | See Plans and Pricing | |
| Croatia | P20040352 | PRIMJENA FLIBANSERINA U LIJEČENJU SEKSUALNE DISFUNKCIJE (USE OF FLIBANSERIN IN THE TREATMENT OF SEXUAL DISORDERS) | See Plans and Pricing |
| South Africa | 200309586 | STABLE POLYMORPH OF FLIBANSERIN TECHNICAL PROCESS FOR ITS PREPARATION AND THE USE THEREOF FOR PREPARING MEDICAMENTS | See Plans and Pricing |
| Serbia | 50876 | UPOTREBA FLIBANSERINA U LEČENJU SEKSUALNIH POREMEĆAJA (USE OF FLIBANSERIN IN THE TREATMENT OF SEXUAL DISORDERS) | See Plans and Pricing |
| Poland | 210224 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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