RITONAVIR Drug Patent Profile

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Ritonavir is a drug marketed by Hikma, Mylan, Amneal, Aurobindo Pharma Ltd, Cipla, and Hetero Labs Ltd Iii. and is included in seven NDAs.

The generic ingredient in RITONAVIR is ritonavir. There are twenty-one drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ritonavir profile page.

A generic version of RITONAVIR was approved as ritonavir by CIPLA on January 15^th, 2015.

US Patents:	0
Applicants:	6
NDAs:	7
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	1,019
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for RITONAVIR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RITONAVIR
DailyMed Link:	RITONAVIR at DailyMed

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

Sponsor	Phase
PENTA Foundation	Phase 1/Phase 2
Centre Mère et Enfant de la Fondation Chantal Biya	Phase 1/Phase 2
AMS-PHPT Research Collaboration	Phase 1/Phase 2

Drug Class	Cytochrome P450 3A Inhibitor Protease Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inducers Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inhibitors HIV Protease Inhibitors P-Glycoprotein Inhibitors UDP Glucuronosyltransferases Inducers

Cytochrome P-450 CYP3A Inhibitors
HIV Protease Inhibitors

J05AE	Protease inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
NORVIR	Tablets	ritonavir	100 mg	022417	1	2010-12-21

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	RITONAVIR	ritonavir	CAPSULE;ORAL	205801-001	Dec 3, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd Iii	RITONAVIR	ritonavir	TABLET;ORAL	204587-001	Sep 17, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	RITONAVIR	ritonavir	TABLET;ORAL	206614-001	Sep 17, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	RITONAVIR	ritonavir	CAPSULE;ORAL	205024-001	Feb 16, 2024		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	RITONAVIR	ritonavir	TABLET;ORAL	208890-001	Sep 17, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cipla	RITONAVIR	ritonavir	TABLET;ORAL	203759-001	May 10, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Mylan S.A.S	Ritonavir Mylan	ritonavir	EMEA/H/C/004549 Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV 1 infected patients (adults and children of 2 years of age and older).	Authorised	yes	no	no	2017-11-09
AbbVie Deutschland GmbH Co. KG	Norvir	ritonavir	EMEA/H/C/000127 Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1-infected patients (adults and children of two years of age and older).	Authorised	no	no	no	1996-08-25
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal