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HARVONI Drug Profile
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» See Plans and PricingWhich 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 five 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. Two suppliers are listed for this compound. Additional details are available on the ledipasvir; sofosbuvir profile page.
US ANDA Litigation and 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: | 505 |
| US Patents: | 17 |
| Applicants: | 1 |
| NDAs: | 2 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 1 |
| Clinical Trials: | 35 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for HARVONI |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for HARVONI |
| DailyMed Link: | HARVONI at DailyMed |
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 |
|---|---|
| University of Maryland | Early Phase 1 |
| KlinEra Global Services | Phase 2 |
| Tanta University | Phase 4 |
Recent Litigation for HARVONI
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Gilead Sciences, Inc. v. Teva Pharmaceuticals USA, Inc. | 2018-03-27 |
| GILEAD SCIENCES, INC. v. NATCO PHARMA LIMITED | 2018-03-14 |
| Idenix Pharmaceuticals LLC v. Gilead Sciences, Inc. | 2014-07-01 |
PTAB Litigation
| Petitioner | Date |
|---|---|
| 2017-12-26 | |
| 2017-12-06 | |
| 2017-11-09 |
Pharmacology for HARVONI
Synonyms for HARVONI
| Ledipasvir / sofosbuvir |
| Ledipasvir and sofosbuvir |
| Ledipasvir mixture with sofosbuvir |
| S900006370 |
| Sofosbuvir / Ledipasvir |
| Sofosbuvir and Ledipasvir |
| Sofosbuvir/Ledipasvir |
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 | Start Trial | Start Trial | Y | Start Trial | |||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-002 | Aug 28, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | PELLETS;ORAL | 212477-002 | Aug 28, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-002 | Aug 28, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | 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 HARVONI
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Singapore | 11201402609R | Start Trial |
| New Zealand | 623602 | Start Trial |
| Chile | 2011002825 | Start Trial |
| Eurasian Patent Organization | 026341 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for HARVONI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2203462 | PA2014040,C2203462 | Lithuania | Start Trial | PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116 |
| 2430014 | 2016004 | Norway | Start Trial | PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958 20141203 |
| 2203462 | 122014000108 | Germany | Start Trial | PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116 |
| 2203462 | C20140035 00135 | Estonia | Start Trial | PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
