Viewing data from:

VARENICLINE TARTRATE

ANDA

VARENICLINE TARTRATE | A201785 | PH HEALTH LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: CHANTIX(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Par Pharmaceutical Inc v. Pfizer Inc et al 1:2019cv00615 2 patentsANDA 201785varenicline tartrate	S.D.N.Y.	2019-01-22	Terminated 2019-03-15	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Medicare Part D Spending

CMS annual spending data for Varenicline Tartrate (2023)

Total Spending

$189.6M

Total Claims

490,761

Beneficiaries

197,586

Avg Cost/Unit

$5.85

Spending Trend

$33.3M(2021)→$151.3M(2022)→$189.6M(2023)

YoY Change:-10.6%

5yr CAGR:-10.8%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain20 active DMFs3 inactive

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

MATRIX PHARMACORP PRIVATE LTDVARENICLINE TARTRATE

DMF 234412010

TAPI NL BVVARENICLINE TARTRATE (AS HPC SOLID SOLUTION) DRUG PRODUCT INTERMEDIATE

DMF 237082010

MEDICHEM SAVARENICLINE TARTRATE (MED-201890/E)

DMF 237282010

APOTEX PHARMACHEM INDIA PVT LTDVARENICLINE TARTRATE

DMF 237742010

ACTAVIS GROUP PTC EHFVARENICLINE TARTRATE MALTODEXTRIN PREMIX (1:10) [DRUG SUBSTANCE (NON-STERILE)]

DMF 237912010

LUPIN LTDVARENICLINE TARTRATE

DMF 315132017

VIWIT PHARMACEUTICAL CO LTDVARENICLINE TARTRATE (DRUG SUBSTANCE, NON-STERILE)

DMF 326382018

JUBILANT PHARMOVA LTDVARENICLINE TARTRATE

DMF 326822018

ENALTEC LABS PRIVATE LTDVARENICLINE TARTRATE

DMF 328352018

LEE PHARMA LTDVARENICLINE TARTRATE

DMF 330162018

MACLEODS PHARMACEUTICALS LTDVARENICLINE TARTRATE

DMF 340962019

PIRAMAL PHARMA LTDVARENICLINE TARTRATE

DMF 341162020

MAITHRI DRUGS PRIVATE LTDVARENICLINE TARTRATE

DMF 341742019

HETERO DRUGS LTDVARENICLINE TARTRATE

DMF 342232019

SHILPA PHARMA LIFESCIENCES LTDVARENICLINE TARTRATE

DMF 350372020

CENTAUR PHARMACEUTICALS PRIVATE LTDVARENICLINE TARTRATE

DMF 370042022

AMOLI ORGANICS (A DIVISION OF UMEDICA LABORATORIES PVT LTD)VARENICLINE TARTRATE

DMF 384712023

DR REDDYS LABORATORIES LTDVARENICLINE TARTRATE

DMF 386932023

UNICHEM LABORATORIES LTDVARENICLINE TARTRATE

DMF 397012024

MSN LABORATORIES PRIVATE LTDVARENICLINE TARTRATE

DMF 412962025

ALP PHARM BEIJING CO LTDInactiveVARENICLINE TARTRATE

DMF 230332009

VIWIT PHARMACEUTICAL CO LTDInactiveVARENICLINE TARTRATE

DMF 301822015

ZHEJIANG CHARIOTEER PHARMACEUTICAL CO LTDInactiveVARENICLINE TARTRATE

DMF 401252024

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 2, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 0.5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Aug 11, 2021

No patent or exclusivity listings for this strength.

#002 — EQ 1MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Aug 11, 2021