Ledipasvir; sofosbuvir - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

What are the generic sources for ledipasvir; sofosbuvir and what is the scope of freedom to operate?

Ledipasvir; sofosbuvir is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ledipasvir; sofosbuvir has five hundred and seventeen patent family members in forty-seven countries.

There is one drug master file entry for ledipasvir; sofosbuvir. One supplier is listed for this compound.

Summary for ledipasvir; sofosbuvir

International Patents:	517
US Patents:	17
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	1
Suppliers / Packagers:	1
Clinical Trials:	92
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ledipasvir; sofosbuvir
DailyMed Link:	ledipasvir; sofosbuvir at DailyMed

Recent Clinical Trials for ledipasvir; sofosbuvir

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Cairo University	Phase 2/Phase 3
Cairo University	Phase 1/Phase 2
Ain Shams University	Phase 1/Phase 2

See all ledipasvir; sofosbuvir clinical trials

Pharmacology for ledipasvir; sofosbuvir

Drug Class	Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	P-Glycoprotein Inhibitors Breast Cancer Resistance Protein Inhibitors RNA Replicase Inhibitors

US Patents and Regulatory Information for ledipasvir; sofosbuvir

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Start Trial
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	205834-002	Aug 28, 2019		RX	Yes	No	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	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes	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	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
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 ledipasvir; sofosbuvir

Subscribe to access the full database, or Start Trial
Country	Patent Number	Estimated Expiration
Japan	2014532657	Start Trial
Norway	2014029	Start Trial
New Zealand	603232	Start Trial
Taiwan	201139457	Start Trial
Croatia	P20160958	Start Trial
Uruguay	35299	Start Trial
Moldova, Republic of	20140035	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for ledipasvir; sofosbuvir

Subscribe to access the full database, or Start Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2430014	PA2016002,C2430014	Lithuania	Start Trial	PRODUCT NAME: LEDIPASVIRAS; REGISTRATION NO/DATE: EU/1/14/958(001-002) 20141117
2203462	2014029	Norway	Start Trial	PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
2430014	16C0005	France	Start Trial	PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118
2203462	CA 2014 00061	Denmark	Start Trial	PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
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
2430014	CA 2016 00006	Denmark	Start Trial	PRODUCT NAME: LEDISPAVIR; REG. NO/DATE: EU/1/14/958/001-002 20141118
2430014	SPC/GB16/008	United Kingdom	Start Trial	PRODUCT NAME: LEDIPASVIR; REGISTERED: UK EU/1/14/958(001-002) 20141118
>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.

By using our website you are consenting to our use of cookies in accordance with our privacy policy.