ledipasvir; sofosbuvir · Gilead Sciences Inc · NDA 205834, 212477

Harvoni

Earliest generic entry, as listed · earliest of 4 marketed strengths

14 Mar 2033

Other strengths are listed to 30 Jul 2034.

Blocked by patent: US 9393256 (pediatric extension).

Listed patents · 17 unexpired

35 Orange Book listing rows for 17 patents, including 16 pediatric extensions. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

Patent	Claims	Expires	Notes
US 10039779	drug substance, drug product, use U-1470, U-2369, U-2370	30 Jul 2034	4 listing rows
US 10039779 listing row	drug substance, drug product, use U-1470	30 Jan 2034	listed 23 Sep 2019
US 10039779 listing row	drug substance, drug product, use U-2369	30 Jan 2034	listed 29 Aug 2018
US 10039779 listing row	drug substance, drug product, use U-2370	30 Jan 2034	listed 29 Aug 2018
US 10039779 listing row	pediatric extension	30 Jul 2034	2 strengths
US 9393256	use U-1470	14 Mar 2033	2 listing rows
US 9393256 listing row	use U-1470	14 Sep 2032	4 strengths · listed 23 Sep 2019
US 9393256 listing row	pediatric extension · sets the listed date	14 Mar 2033	4 strengths
US 10456414	drug product	14 Sep 2032	4 strengths · listed 20 Nov 2019
US 8618076	drug substance, drug product, use U-1470	11 Jun 2031	2 listing rows
US 8618076 listing row	drug substance, drug product, use U-1470	11 Dec 2030	4 strengths · listed 23 Sep 2019
US 8618076 listing row	pediatric extension	11 Jun 2031	4 strengths
US 9284342	drug substance, drug product, use U-1470	13 Mar 2031	2 listing rows
US 9284342 listing row	drug substance, drug product, use U-1470	13 Sep 2030	4 strengths · listed 12 Apr 2016
US 9284342 listing row	pediatric extension	13 Mar 2031	4 strengths
US 8088368	drug substance, drug product	12 Nov 2030	2 listing rows
US 8088368 listing row	drug substance, drug product	12 May 2030	4 strengths · listed 23 Sep 2019
US 8088368 listing row	pediatric extension	12 Nov 2030	4 strengths
US 8273341	use U-1470	12 Nov 2030	2 listing rows
US 8273341 listing row	use U-1470	12 May 2030	4 strengths · listed 30 Oct 2014
US 8273341 listing row	pediatric extension	12 Nov 2030	4 strengths
US 8822430	drug substance, drug product, use U-1470	12 Nov 2030	2 listing rows
US 8822430 listing row	drug substance, drug product, use U-1470	12 May 2030	4 strengths · listed 30 Oct 2014
US 8822430 listing row	pediatric extension	12 Nov 2030	4 strengths
US 8841278	drug product, use U-1470	12 Nov 2030	2 listing rows
US 8841278 listing row	drug product, use U-1470	12 May 2030	4 strengths · listed 23 Sep 2019
US 8841278 listing row	pediatric extension	12 Nov 2030	4 strengths
US 9511056	use U-1470	12 Nov 2030	2 listing rows
US 9511056 listing row	use U-1470	12 May 2030	4 strengths · listed 23 Sep 2019
US 9511056 listing row	pediatric extension	12 Nov 2030	4 strengths
US 7964580	drug substance, drug product, use U-1470	26 Sep 2029	2 listing rows
US 7964580 listing row	drug substance, drug product, use U-1470	26 Mar 2029	4 strengths · listed 23 Sep 2019
US 7964580 listing row	pediatric extension	26 Sep 2029	4 strengths
US 8633309	drug substance, drug product, use U-1470	26 Sep 2029	2 listing rows
US 8633309 listing row	drug substance, drug product, use U-1470	26 Mar 2029	4 strengths · listed 30 Oct 2014
US 8633309 listing row	pediatric extension	26 Sep 2029	4 strengths
US 8889159	drug product, use U-1470	26 Sep 2029	2 listing rows
US 8889159 listing row	drug product, use U-1470	26 Mar 2029	4 strengths · listed 11 Dec 2014
US 8889159 listing row	pediatric extension	26 Sep 2029	4 strengths
US 8334270	drug substance, drug product, use U-1470	21 Sep 2028	2 listing rows
US 8334270 listing row	drug substance, drug product, use U-1470	21 Mar 2028	4 strengths · listed 23 Sep 2019
US 8334270 listing row	pediatric extension	21 Sep 2028	4 strengths
US 8580765	drug substance, drug product, use U-1470	21 Sep 2028	2 listing rows
US 8580765 listing row	drug substance, drug product, use U-1470	21 Mar 2028	4 strengths · listed 23 Sep 2019
US 8580765 listing row	pediatric extension	21 Sep 2028	4 strengths
US 8735372	use U-1470	21 Sep 2028	2 listing rows
US 8735372 listing row	use U-1470	21 Mar 2028	4 strengths · listed 23 Sep 2019
US 8735372 listing row	pediatric extension	21 Sep 2028	4 strengths
US 9085573	drug substance, drug product, use U-1470	21 Sep 2028	2 listing rows
US 9085573 listing row	drug substance, drug product, use U-1470	21 Mar 2028	4 strengths · listed 23 Sep 2019
US 9085573 listing row	pediatric extension	21 Sep 2028	4 strengths

Exclusivities · 0 unexpired

No unexpired exclusivities listed.

Paragraph IV certifications · 0

No Paragraph IV certification listed by FDA for this drug.

The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.

Event history

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 4

NDA · product	Form	Strength	Approved	Listed expiry
205834 · 001 · RLD	tablet, oral	90MG;400MG	10 Oct 2014	30 Jul 2034
205834 · 002 · RLD	tablet, oral	45MG;200MG	28 Aug 2019	30 Jul 2034
212477 · 001 · RLD	pellets, oral	33.75MG/PACKET;150MG/PACKET	28 Aug 2019	14 Mar 2033
212477 · 002 · RLD	pellets, oral	45MG/PACKET;200MG/PACKET	28 Aug 2019	14 Mar 2033

Expired or delisted (4)

ODE* · 28 Aug 2026
ODE-262 · 28 Aug 2026
ODE-263 · 28 Aug 2026
ODE-264 · 28 Aug 2026