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HARVONI Drug Profile
When do Harvoni patents expire, and what generic alternatives are available?
Harvoni is a drug marketed by Gilead Sciences Inc and is included in two NDAs. There are sixteen patents protecting this drug.
This drug has four hundred and ninety-two 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.
Summary for HARVONI
| International Patents: | 492 |
| US Patents: | 16 |
| 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 Date for HARVONI*:
Constraining patent/regulatory exclusivity:
PEDIATRIC 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 |
|---|---|
| Initiative for Medicines, Access & Knowledge (I-MAK), Inc. | 2017-12-26 |
| Initiative for Medicines, Access & Knowledge (I-MAK), Inc. | 2017-12-06 |
| Initiative for Medicines, Access & Knowledge (I-MAK), Inc. | 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 | PELLETS;ORAL | 212477-001 | Aug 28, 2019 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| 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 | 205834-001 | Oct 10, 2014 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-001 | Oct 10, 2014 | RX | Yes | Yes | 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 |
|---|---|---|
| New Zealand | 623602 | Start Trial |
| Montenegro | 03009 | Start Trial |
| Singapore | 10201702294Q | Start Trial |
| Poland | 2432792 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for HARVONI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2430014 | 122016000009 | Germany | Start Trial | PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117 |
| 2203462 | C02203462/01 | Switzerland | Start Trial | PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014 |
| 2430014 | 1690002-9 | Sweden | Start Trial | PRODUCT NAME: ; REG. NO/DATE: EU/1/14/958 20141118 |
| 2203462 | C300704 | Netherlands | Start Trial | PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
