NORVIR Drug Patent Profile

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Which patents cover Norvir, and what generic alternatives are available?

Norvir is a drug marketed by Abbott and Abbvie and is included in five NDAs.

The generic ingredient in NORVIR 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Norvir

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

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Summary for NORVIR

US Patents:	0
Applicants:	2
NDAs:	5
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	95
Patent Applications:	4,162
Drug Prices:	Drug price information for NORVIR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NORVIR
What excipients (inactive ingredients) are in NORVIR?	NORVIR excipients list
DailyMed Link:	NORVIR at DailyMed

Drug patent expirations by year for NORVIR

Recent Clinical Trials for NORVIR

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

Sponsor	Phase
Pyramid Biosciences	Phase 1
Pardes Biosciences, Inc.	Phase 1
Soroka University Medical Center	Phase 3

See all NORVIR clinical trials

Pharmacology for NORVIR

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

Paragraph IV (Patent) Challenges for NORVIR

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

US Patents and Regulatory Information for NORVIR

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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
Abbott	NORVIR	ritonavir	CAPSULE;ORAL	020680-001	Mar 1, 1996		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	NORVIR	ritonavir	CAPSULE;ORAL	020945-001	Jun 29, 1999		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	NORVIR	ritonavir	POWDER;ORAL	209512-001	Jun 7, 2017		RX	Yes	Yes	⤷ 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 NORVIR

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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	SOLUTION;ORAL	020659-001	Mar 1, 1996	⤷ Sign Up	⤷ Sign Up
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996	⤷ Sign Up	⤷ Sign Up
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for NORVIR

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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

International Patents for NORVIR

See the table below for patents covering NORVIR around the world.

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Country	Patent Number	Title	Estimated Expiration
Denmark	0402646		⤷ Sign Up
Hong Kong	1012337		⤷ Sign Up
Croatia	P20181819		⤷ Sign Up
Canada	2017252	COMPOSES INHIBITEURS DE LA PROTEASE DES RETROVIRUS (RETROVIRAL PROTEASE INHIBITING COMPOUNDS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for NORVIR

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0674513	C300060	Netherlands	⤷ Sign Up	PRODUCT NAME: RITONAVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT OF EEN FARMACEUTISCH AANVAARDBARE ESTER, EN LOPINAVIR; REGISTRATION NO/DATE: EU/1/01/172/001 - EU/1/01/172/003 20010320
0674513	SPC/GB01/044	United Kingdom	⤷ Sign Up	PRODUCT NAME: THE COMBINATION OF THE ACTIVE INGREDIENTS RITONAVIR AND LOPINAVIR; REGISTERED: CH 55649 20001213; UK EU/1/01/172/001 20010320; UK EU/1/01/172/002 20010320; UK EU/1/01/172/003 20010320
0674513	C00674513	Switzerland	⤷ Sign Up	PRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description