Viewing data from:

DAKLINZA

NDA

DACLATASVIR DIHYDROCHLORIDE | N206843 | BRISTOL-MYERS SQUIBB CO

3 strengths5 unique patents0 unique exclusivities

Patent Timeline

5 unique patents by expiration date

Active (5)Today

2027

2028

2029

2030

2031

Today

Jul. 24, 2029

Jun. 13, 2031

Aug. 11, 2027

Aug. 8, 2027

Aug. 8, 2027

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs1 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

HETERO LABS LTDDACLATASVIR DIHYDROCHLORIDE

DMF 309752016

ALIVUS LIFE SCIENCES LTDDACLATASVIR DIHYDROCHLORIDE

DMF 324712018

FUXIN LONG RUI PHARMACEUTICAL CO LTDDACLATASVIR DIHYDROCHLORIDE

DMF 333812018

MSN LIFE SCIENCES PRIVATE LTDDACLATASVIR DIHYDROCHLORIDE

DMF 334962018

CIPLA LTDInactiveDACLATASVIR DIHYDROCHLORIDE

DMF 307372016

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Oct 17, 2019	SUPPL -8	View Letter (PDF)
Nov 13, 2017	SUPPL -7	View Letter (PDF)
Feb 15, 2017	SUPPL -6	View Letter (PDF)
Feb 9, 2016	SUPPL -2	View Letter (PDF)
Feb 9, 2016	SUPPL -1	View Letter (PDF)
Feb 9, 2016	SUPPL -3	View Letter (PDF)
Jul 28, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 30MG BASE

RLD

5 patents0 exclusivities▴

TABLET;ORAL | Approved: Jul 24, 2015

Patents (5)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8329159	Jul 24, 2029	—	Yes	—	—	—
8629171	Jun 13, 2031	—	Yes	Yes		—
8642025	Aug 11, 2027	—	Yes	Yes		—
8900566	Aug 8, 2027	—	—	—		—
9421192	Aug 8, 2027	—	Yes	—		—

#002 — EQ 60MG BASE

RLD

5 patents0 exclusivities▾

TABLET;ORAL | Approved: Jul 24, 2015

#003 — EQ 90MG BASE

RLD

1 patent0 exclusivities▾

TABLET;ORAL | Approved: Apr 13, 2016