RITONAVIR - Generic Drug Details

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What are the generic sources for ritonavir and what is the scope of freedom to operate?

Ritonavir is the generic ingredient in two branded drugs marketed by Abbott, Abbvie, Hikma, Norvium Bioscience, Amneal, Aurobindo Pharma Ltd, Cipla, and Hetero Labs Ltd Iii, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for ritonavir. Seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for RITONAVIR

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	12
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	1,019
Drug Prices:	Drug price trends for RITONAVIR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RITONAVIR
What excipients (inactive ingredients) are in RITONAVIR?	RITONAVIR excipients list
DailyMed Link:	RITONAVIR at DailyMed

See drug prices for RITONAVIR

Recent Clinical Trials for RITONAVIR

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

Sponsor	Phase
AMS-PHPT Research Collaboration	Phase 1/Phase 2
University of Zimbabwe Clinical Research Centre (UZCRC)	Phase 1/Phase 2
Centre Hospitalier National d'Enfants Albert Royer	Phase 1/Phase 2

See all RITONAVIR clinical trials

Generic filers with tentative approvals for RITONAVIR

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	100MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	50MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	25MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for RITONAVIR

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

Medical Subject Heading (MeSH) Categories for RITONAVIR

Cytochrome P-450 CYP3A Inhibitors
HIV Protease Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for RITONAVIR

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

Paragraph IV (Patent) Challenges for RITONAVIR

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

US Patents and Regulatory Information for RITONAVIR

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Glossary

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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
Cipla	RITONAVIR	ritonavir	TABLET;ORAL	203759-001	May 10, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	RITONAVIR	ritonavir	CAPSULE;ORAL	205024-001	Feb 16, 2024		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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for RITONAVIR

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NORVIR	ritonavir	CAPSULE;ORAL	020945-001	Jun 29, 1999	⤷ Sign Up	⤷ Sign Up
Abbvie	NORVIR	ritonavir	CAPSULE;ORAL	020945-001	Jun 29, 1999	⤷ Sign Up	⤷ Sign Up
Abbvie	NORVIR	ritonavir	CAPSULE;ORAL	020945-001	Jun 29, 1999	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for RITONAVIR

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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

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