Viewing data from:

RITONAVIR

ANDA

RITONAVIR | A202573 | CIPLA LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: NORVIR(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
AbbVie Inc. v. Roxane Laboratories Inc. 1:2012cv00457 3 patentsANDA 202573ritonavir	D. Del.	2012-04-10	Terminated 2013-06-28	—

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

Medicare Part D Spending

CMS annual spending data for Ritonavir (2023)

Total Spending

$9.8M

Total Claims

59,057

Beneficiaries

7,866

Avg Cost/Unit

$3.31

Spending Trend

$20.0M(2019)→$14.4M(2020)→$10.9M(2021)→$11.4M(2022)→$9.8M(2023)

YoY Change:+2.1%

5yr CAGR:-0.8%

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

API Supply Chain15 active DMFs6 inactive

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

APITORIA PHARMA PRIVATE LTDRITONAVIR USP

DMF 190372005

MATRIX PHARMACORP PRIVATE LTDRITONAVIR USP (FORM-II)

DMF 198002006

DR REDDYS LABORATORIES LTDRITONAVIR USP

DMF 235912010

OLON SPARITONAVIR

DMF 239352010

SHANGHAI DESANO CHEMICAL PHARMACEUTICAL CO LTDRITONAVIR USP

DMF 243832010

HETERO DRUGS LTDRITONAVIR USP (FORM I), PROCESS II

DMF 246292011

HETERO DRUGS LTDRITONAVIR PREMIX AMORPHOUS

DMF 261782012

CIPLA LTDRITONAVIR USP

DMF 264432013

EMCURE PHARMACEUTICALS LTDRITONAVIR USP (PROCESS II)

DMF 264632012

LAURUS LABS LTDRITONAVIR USP

DMF 333422019

HETERO LABS LTDRITONAVIR USP

DMF 334782019

ARENE LIFE SCIENCES PRIVATE LTDRITONAVIR USP

DMF 348462020

CHROMO LABORATORIES INDIA PRIVATE LTDRITONAVIR USP

DMF 353032020

RUYUAN HEC PHARM CO LTDRITONAVIR NON-STERILE BULK DRUG SUBSTANCE

DMF 366732022

LUPIN MANUFACTURING SOLUTIONS LTDRITONAVIR USP

DMF 370502022

FINORGA SASInactiveRITONAVIR

DMF 116661995

MYLAN LABORATORIES LTDInactiveRITONAVIR USP (FORM I)

DMF 198392006

RANBAXY LABORATORIES LTDInactiveRITONAVIR

DMF 211452007

LUPIN LTDInactiveRITONAVIR USP

DMF 235422010

EMCURE PHARMACEUTICALS LTDInactiveRITONAVIR USP

DMF 240302010

LUPIN LTDInactiveRITONAVIR COPOVIDONE

DMF 247152011

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jan 16, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Jan 15, 2015

No patent or exclusivity listings for this strength.