HARVONI Drug Patent Profile
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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 forty-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: | 541 |
| US Patents: | 17 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 36 |
| 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, College Park | Early Phase 1 |
Pharmacology for HARVONI
Anatomical Therapeutic Chemical (ATC) Classes for HARVONI
US Patents and Regulatory Information for HARVONI
HARVONI is protected by seventeen US patents and eight FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of HARVONI 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 HARVONI
Combination formulation of two antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Methods for treating HCV
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Nucleoside phosphoramidates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Nucleoside phosphoramidates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Compositions and methods for treating hepatitis C virus
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Nucleoside phosphoramidate prodrugs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Nucleoside phosphoramidates
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Methods for treating HCV
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Antiviral compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting HARVONI
TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH CHRONIC HCV GENOTYPE 1 INFECTION WITH DECOMPENSATED CIRRHOSIS, FOR USE IN COMBINATION WITH RIBAVIRIN
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF PEDIATRIC PATIENTS BETWEEN 3 YEARS OF AGE AND 12 YEARS OF AGE OR WEIGHING 35 KG WITH CHRONIC HEPATITIS C VIRUS (HCV) GENOTYPE 1, 4, 5, OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER WITH CHRONIC HCV GENOTYPE 1 OR 4 INFECTION WHO ARE LIVER TRANSPLANT RECIPIENTS WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS, FOR USE IN COMBINATION WITH RIBAVIRIN
Exclusivity Expiration: See Plans and Pricing
INFORMATION ADDED TO THE DOSING SECTION IN REGARD TO THE TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDING PATIENTS WITH END STAGE RENAL DISEASE ON DIALYSIS
Exclusivity Expiration: See Plans and Pricing
FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: See Plans and Pricing
FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: See Plans and Pricing
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing
TREATMENT OF PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER OR WEIGHING AT LEAST 35 KG WITH CHRONIC HEPATITIS C VIRUS GENOTYPE 1, 4, 5, OR 6 INFECTION WITHOUT CIRRHOSIS OR WITH COMPENSATED CIRRHOSIS
Exclusivity Expiration: 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-001 | Oct 10, 2014 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | TABLET;ORAL | 205834-002 | Aug 28, 2019 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| Gilead Sciences Inc | HARVONI | ledipasvir; sofosbuvir | PELLETS;ORAL | 212477-002 | Aug 28, 2019 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | 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 HARVONI
When does loss-of-exclusivity occur for HARVONI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 8580
Estimated Expiration: See Plans and Pricing
Patent: 9578
Estimated Expiration: See Plans and Pricing
Patent: 5131
Estimated Expiration: See Plans and Pricing
Australia
Patent: 12308295
Estimated Expiration: See Plans and Pricing
Patent: 12332827
Estimated Expiration: See Plans and Pricing
Patent: 12346217
Estimated Expiration: See Plans and Pricing
Patent: 14202687
Estimated Expiration: See Plans and Pricing
Patent: 15202842
Estimated Expiration: See Plans and Pricing
Patent: 16216641
Estimated Expiration: See Plans and Pricing
Patent: 18203696
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 2014006324
Estimated Expiration: See Plans and Pricing
Patent: 2014010295
Estimated Expiration: See Plans and Pricing
Patent: 2014011938
Estimated Expiration: See Plans and Pricing
Patent: 2014012739
Estimated Expiration: See Plans and Pricing
Canada
Patent: 40242
Estimated Expiration: See Plans and Pricing
Patent: 52867
Estimated Expiration: See Plans and Pricing
Patent: 53495
Estimated Expiration: See Plans and Pricing
Patent: 56529
Estimated Expiration: See Plans and Pricing
Chile
Patent: 14000630
Estimated Expiration: See Plans and Pricing
Patent: 14001397
Estimated Expiration: See Plans and Pricing
Patent: 15002164
Estimated Expiration: See Plans and Pricing
China
Patent: 4039319
Estimated Expiration: See Plans and Pricing
Patent: 4144682
Estimated Expiration: See Plans and Pricing
Patent: 4244945
Estimated Expiration: See Plans and Pricing
Patent: 4244947
Estimated Expiration: See Plans and Pricing
Patent: 5748499
Estimated Expiration: See Plans and Pricing
Patent: 6166160
Estimated Expiration: See Plans and Pricing
Colombia
Patent: 30366
Estimated Expiration: See Plans and Pricing
Patent: 70603
Estimated Expiration: See Plans and Pricing
Costa Rica
Patent: 140177
Estimated Expiration: See Plans and Pricing
Patent: 140273
Estimated Expiration: See Plans and Pricing
Patent: 150453
Estimated Expiration: See Plans and Pricing
Croatia
Patent: 0180237
Estimated Expiration: See Plans and Pricing
Patent: 0200138
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 19896
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 09613
Estimated Expiration: See Plans and Pricing
Patent: 50786
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 14005678
Estimated Expiration: See Plans and Pricing
Patent: 14013312
Estimated Expiration: See Plans and Pricing
Patent: 15037311
Estimated Expiration: See Plans and Pricing
Patent: 21087299
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 6667
Estimated Expiration: See Plans and Pricing
Patent: 7296
Estimated Expiration: See Plans and Pricing
Patent: 9081
Estimated Expiration: See Plans and Pricing
Patent: 1490588
Estimated Expiration: See Plans and Pricing
Patent: 1490806
Estimated Expiration: See Plans and Pricing
Patent: 1490903
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 09613
Estimated Expiration: See Plans and Pricing
Patent: 76024
Estimated Expiration: See Plans and Pricing
Patent: 85340
Estimated Expiration: See Plans and Pricing
Patent: 50786
Estimated Expiration: See Plans and Pricing
Patent: 50013
Estimated Expiration: See Plans and Pricing
Patent: 77867
Estimated Expiration: See Plans and Pricing
Germany
Patent: 2012013074
Estimated Expiration: See Plans and Pricing
Patent: 2012013382
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 02268
Estimated Expiration: See Plans and Pricing
Patent: 19869
Estimated Expiration: See Plans and Pricing
Patent: 31378
Estimated Expiration: See Plans and Pricing
Hungary
Patent: 36588
Estimated Expiration: See Plans and Pricing
Patent: 47777
Estimated Expiration: See Plans and Pricing
Israel
Patent: 1515
Estimated Expiration: See Plans and Pricing
Patent: 2889
Estimated Expiration: See Plans and Pricing
Patent: 3419
Estimated Expiration: See Plans and Pricing
Japan
Patent: 99327
Estimated Expiration: See Plans and Pricing
Patent: 73897
Estimated Expiration: See Plans and Pricing
Patent: 23002
Estimated Expiration: See Plans and Pricing
Patent: 20994
Estimated Expiration: See Plans and Pricing
Patent: 14526516
Estimated Expiration: See Plans and Pricing
Patent: 14532657
Estimated Expiration: See Plans and Pricing
Patent: 14533733
Estimated Expiration: See Plans and Pricing
Patent: 15508418
Estimated Expiration: See Plans and Pricing
Patent: 16053096
Estimated Expiration: See Plans and Pricing
Patent: 16155875
Estimated Expiration: See Plans and Pricing
Patent: 16166251
Estimated Expiration: See Plans and Pricing
Patent: 17057230
Estimated Expiration: See Plans and Pricing
Lithuania
Patent: 09613
Estimated Expiration: See Plans and Pricing
Patent: 50786
Estimated Expiration: See Plans and Pricing
Malaysia
Patent: 7735
Estimated Expiration: See Plans and Pricing
Mexico
Patent: 6580
Estimated Expiration: See Plans and Pricing
Patent: 1816
Estimated Expiration: See Plans and Pricing
Patent: 4958
Estimated Expiration: See Plans and Pricing
Patent: 14003145
Estimated Expiration: See Plans and Pricing
Patent: 14005955
Estimated Expiration: See Plans and Pricing
Patent: 14006373
Estimated Expiration: See Plans and Pricing
Moldova, Republic of
Patent: 30
Estimated Expiration: See Plans and Pricing
Patent: 89
Estimated Expiration: See Plans and Pricing
Patent: 95
Estimated Expiration: See Plans and Pricing
Patent: 140035
Estimated Expiration: See Plans and Pricing
Patent: 140058
Estimated Expiration: See Plans and Pricing
Patent: 150080
Estimated Expiration: See Plans and Pricing
Montenegro
Patent: 009
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 906
Estimated Expiration: See Plans and Pricing
Patent: 150030
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 3396
Estimated Expiration: See Plans and Pricing
Patent: 5087
Estimated Expiration: See Plans and Pricing
Patent: 5532
Estimated Expiration: See Plans and Pricing
Patent: 0391
Estimated Expiration: See Plans and Pricing
Patent: 9172
Estimated Expiration: See Plans and Pricing
Peru
Patent: 141056
Estimated Expiration: See Plans and Pricing
Patent: 141296
Estimated Expiration: See Plans and Pricing
Patent: 151778
Estimated Expiration: See Plans and Pricing
Philippines
Patent: 014501133
Estimated Expiration: See Plans and Pricing
Patent: 015501710
Estimated Expiration: See Plans and Pricing
Poland
Patent: 09613
Estimated Expiration: See Plans and Pricing
Patent: 50786
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 09613
Estimated Expiration: See Plans and Pricing
Patent: 50786
Estimated Expiration: See Plans and Pricing
Serbia
Patent: 975
Estimated Expiration: See Plans and Pricing
Singapore
Patent: 201602044W
Estimated Expiration: See Plans and Pricing
Patent: 201706949V
Estimated Expiration: See Plans and Pricing
Patent: 201400664W
Estimated Expiration: See Plans and Pricing
Patent: 201402609R
Estimated Expiration: See Plans and Pricing
Patent: 201506021X
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 09613
Estimated Expiration: See Plans and Pricing
Patent: 50786
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 1404061
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1560994
Estimated Expiration: See Plans and Pricing
Patent: 1962522
Estimated Expiration: See Plans and Pricing
Patent: 1991298
Estimated Expiration: See Plans and Pricing
Patent: 140096029
Estimated Expiration: See Plans and Pricing
Patent: 140108645
Estimated Expiration: See Plans and Pricing
Patent: 140119012
Estimated Expiration: See Plans and Pricing
Patent: 160052797
Estimated Expiration: See Plans and Pricing
Patent: 190033643
Estimated Expiration: See Plans and Pricing
Patent: 190075142
Estimated Expiration: See Plans and Pricing
Patent: 200060782
Estimated Expiration: See Plans and Pricing
Spain
Patent: 59216
Estimated Expiration: See Plans and Pricing
Patent: 71458
Estimated Expiration: See Plans and Pricing
Patent: 17886
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 66773
Estimated Expiration: See Plans and Pricing
Patent: 26047
Estimated Expiration: See Plans and Pricing
Patent: 1318627
Estimated Expiration: See Plans and Pricing
Patent: 1325599
Estimated Expiration: See Plans and Pricing
Patent: 1444556
Estimated Expiration: See Plans and Pricing
Patent: 1840311
Estimated Expiration: See Plans and Pricing
Patent: 2042808
Estimated Expiration: See Plans and Pricing
Turkey
Patent: 1802537
Estimated Expiration: See Plans and Pricing
Ukraine
Patent: 4097
Estimated Expiration: See Plans and Pricing
Patent: 6087
Estimated Expiration: See Plans and Pricing
Patent: 8256
Estimated Expiration: See Plans and Pricing
Uruguay
Patent: 420
Estimated Expiration: See Plans and Pricing
Patent: 474
Estimated Expiration: See Plans and Pricing
Patent: 299
Estimated Expiration: 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.
See the table below for additional patents covering HARVONI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Cyprus | 1119273 | See Plans and Pricing | |
| Spain | 2548156 | See Plans and Pricing | |
| Singapore | 11201400664W | METHODS FOR TREATING HCV | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for HARVONI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2430014 | 132016000015690 | Italy | See Plans and Pricing | PRODUCT NAME: LEDIPASVIR(HARVONI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/958, 20141118 |
| 2430014 | 2016004 | Norway | See Plans and Pricing | PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958 20141203 |
| 2430014 | 2016/002 | Ireland | See Plans and Pricing | PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
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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