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HARVONI Drug Profile
» See Plans and Pricing
Which patents cover Harvoni, and what generic alternatives are available?
Harvoni is a drug marketed by Gilead Sciences Inc and is included in two NDAs. There are seventeen patents protecting this drug.
This drug has five hundred and thirty-one patent family members in forty-seven countries.
The generic ingredient in HARVONI is ledipasvir; sofosbuvir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ledipasvir; sofosbuvir profile page.
DrugPatentWatch® Generic Entry Outlook for Harvoni
Harvoni was eligible for patent challenges on October 10, 2018.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be September 14, 2032. This may change due to patent challenges or generic licensing.
There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for HARVONI
| International Patents: | 531 |
| US Patents: | 17 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 38 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for HARVONI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HARVONI |
| What excipients (inactive ingredients) are in HARVONI? | HARVONI excipients list |
| DailyMed Link: | HARVONI at DailyMed |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for HARVONI
Generic Entry Dates for HARVONI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
PELLETS;ORAL |
Generic Entry Dates for HARVONI*:
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.
Recent Clinical Trials for HARVONI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Mansoura University | Phase 3 |
| Cairo University | Phase 2/Phase 3 |
| University of Maryland | Early Phase 1 |
Pharmacology for HARVONI
US Patents and Regulatory Information for HARVONI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-001 | Oct 10, 2014 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-002 | Aug 28, 2019 | RX | Yes | No | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | PELLETS;ORAL | 212477-002 | Aug 28, 2019 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-002 | Aug 28, 2019 | RX | Yes | No | Get Started for $10 | Get Started for $10 | Y | Get Started for $10 | |||
| >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 HARVONI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Uruguay | 34474 | Get Started for $10 |
| Japan | 6377781 | Get Started for $10 |
| Taiwan | 201902477 | Get Started for $10 |
| Taiwan | I576352 | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for HARVONI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2203462 | 132014902310732 | Italy | Get Started for $10 | PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117 |
| 2203462 | C300704 | Netherlands | Get Started for $10 | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
| 2430014 | SPC/GB16/008 | United Kingdom | Get Started for $10 | PRODUCT NAME: LEDIPASVIR; REGISTERED: UK EU/1/14/958(001-002) 20141118 |
| 2203462 | C20140035 00135 | Estonia | Get Started for $10 | PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
