NORVIR Drug Patent Profile

When do Norvir patents expire, and when can generic versions of Norvir launch?

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. Seven 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.

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

See drug prices 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

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
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996		DISCN	Yes	No
Abbvie	NORVIR	ritonavir	CAPSULE;ORAL	020945-001	Jun 29, 1999		DISCN	Yes	No
Abbvie	NORVIR	ritonavir	POWDER;ORAL	209512-001	Jun 7, 2017		RX	Yes	Yes
Abbvie	NORVIR	ritonavir	TABLET;ORAL	022417-001	Feb 10, 2010	AB	RX	Yes	Yes

Expired US Patents for NORVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996	5,948,436*PED
Abbvie	NORVIR	ritonavir	CAPSULE;ORAL	020945-001	Jun 29, 1999	5,846,987*PED
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996	5,484,801*PED
Abbvie	NORVIR	ritonavir	TABLET;ORAL	022417-001	Feb 10, 2010	7,148,359*PED
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996	5,846,987*PED
Abbvie	NORVIR	ritonavir	SOLUTION;ORAL	020659-001	Mar 1, 1996	6,037,157*PED
Abbvie	NORVIR	ritonavir	CAPSULE;ORAL	020945-001	Jun 29, 1999	6,703,403*PED

EU/EMA Drug Approvals for NORVIR

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

International Patents for NORVIR

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

Country	Patent Number	Title	Estimated Expiration
Ukraine	89220	СПОСОБ ЛЕЧЕНИЯ ВИЧ/СПИДА ПУТЕМ ПРИЕМА БЕЗ ПИЩИ ИЛИ В УСЛОВИЯХ ГОЛОДАНИЯ ТВЕРДОГО ФАРМАЦЕВТИЧЕСКОГО ДОЗИРОВАННОГО СОСТАВА ИНГИБИТОРА ВИЧ-ПРОТЕАЗЫ;СПОСІБ ЛІКУВАННЯ ВІЛ/СНІДУ ШЛЯХОМ ПРИЙОМУ БЕЗ ЇЖІ АБО В УМОВАХ ГОЛОДУВАННЯ ТВЕРДОГО ФАРМАЦЕВТИЧНОГО ДОЗОВАНОГО СКЛАДУ ІНГІБІТОРА ВІЛ-ПРОТЕАЗИ (METHOD FOR TREATMENT OF HIV/AIDS BY ADMINISTRATION OF SOLID PHARMACEUTICAL DOSAGE FORMULATION COMPRISING A HIV PROTEASE INHIBITOR IN FASTED STATE)
European Patent Office	2206500	Forme posologique pharmaceutique solide comprenant du lopinavir (A solid pharmaceutical dosage formulation comprising lopinavir)
Portugal	2283844
Japan	2761374
South Korea	101429024
European Patent Office	2283844	Forme posologique pharmaceutique solide comprenant du lopinavir (A solid pharmaceutical dosage formulation comprising lopinavir)
Israel	122546	COMBINATION OF RITONAVIR AND A DRUG METABOLIZED BY CYTOCHROME P450 MONOXYGENASE AND PHARMACEUTICAL COMPOSITION COMPRISING THE SAME

Supplementary Protection Certificates for NORVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0674513	C00674513	Switzerland		PRODUCT NAME: LOPINAVIR UND RITONAVIR; REGISTRATION NO/DATE: IKS 55648 20001213
0674513	C300060	Netherlands		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		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

NORVIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: NORVIR

Introduction

NORVIR, also known as ritonavir, is a protease inhibitor used primarily in the treatment of HIV/AIDS. Since its introduction in 1996, the drug has played a significant role in the management of HIV, both as a standalone treatment and as a booster to enhance the effectiveness of other protease inhibitors. Here, we delve into the market dynamics and financial trajectory of NORVIR.

Historical Context and Approval

NORVIR was approved by the FDA in 1996 and has been marketed by Abbott Laboratories (now AbbVie) since then. Its approval marked a significant milestone in the treatment of HIV/AIDS, offering patients a new therapeutic option[1][4].

Market Position and Usage

NORVIR has been widely prescribed by physicians as a booster drug to increase the effectiveness of other protease inhibitors. Its role in HIV treatment has been crucial, especially in combination therapies. The drug's availability and widespread use have contributed to its strong market position[1].

Pricing and Accessibility

The pricing of NORVIR has been a subject of controversy, with concerns raised over its affordability. In 2003, there was significant public and congressional pressure on the NIH to exercise its march-in rights under the Bayh-Dole Act to address the high price of NORVIR. However, the NIH determined that Abbott had met the criteria for practical application and health or safety needs, and thus did not initiate march-in proceedings[1].

Financial Performance

Industry analysts have projected strong financial performance for NORVIR. By 2004, it was estimated that Abbott would generate $2 billion in NORVIR sales over the next decade, nearly doubling the $1 billion it had already earned since the drug's introduction. This projection underscored the drug's commercial success and its significant contribution to Abbott's revenue[5].

Sales and Revenue

NORVIR has been a lucrative product for Abbott. The drug's sales have been driven by its essential role in HIV treatment regimens. The financial success of NORVIR is evident from the projected sales figures, which indicated a substantial increase in revenue over the years following its approval[5].

Competitive Landscape

The market for HIV treatments is highly competitive, with multiple protease inhibitors and combination therapies available. However, NORVIR's unique role as a booster drug has helped it maintain a strong position in the market. The drug's compatibility with other antiretroviral agents and its efficacy in enhancing their performance have made it a preferred choice among healthcare providers[1][4].

Regulatory and Legal Considerations

The pricing and availability of NORVIR have been subject to regulatory scrutiny. The NIH's decision not to exercise its march-in rights was based on the determination that Abbott had fulfilled the requirements of the Bayh-Dole Act, including making the drug widely available and addressing health or safety needs. The FTC has also been involved in investigating potential anti-competitive practices related to the pricing of NORVIR[1].

Side Effects and Safety Profile

While NORVIR has been effective in treating HIV/AIDS, it is associated with several side effects and safety concerns. These include elevations in total cholesterol and triglycerides, new onset or exacerbations of diabetes mellitus, immune reconstitution syndrome, and fat redistribution. The drug also has significant interactions with other medications, which must be carefully managed[4].

Recent Clinical Trials and Applications

Beyond its traditional use in HIV treatment, NORVIR has been explored in other clinical contexts. For example, the combination of nirmatrelvir and ritonavir (Paxlovid) has been approved for the treatment of mild to moderate COVID-19. Recent clinical trials have also investigated the efficacy of this combination in treating postacute sequelae of SARS-CoV-2 infection (PASC), although the results have been mixed and further studies are needed[3].

Market Trends and Future Outlook

The market for antiretroviral drugs, including NORVIR, continues to evolve with advancements in medical research and changing patient needs. The integration of NORVIR into combination therapies and its potential applications in treating other viral infections suggest a continued role for the drug in the pharmaceutical market. However, the landscape is also influenced by factors such as drug pricing, regulatory policies, and the emergence of new treatments.

Key Takeaways

• Historical Significance: NORVIR was approved in 1996 and has been a cornerstone in HIV/AIDS treatment.
• Market Position: It is widely used as a booster drug to enhance the effectiveness of other protease inhibitors.
• Financial Performance: Projected to generate significant revenue, with estimated sales of $2 billion over a decade.
• Regulatory Considerations: Subject to scrutiny over pricing and accessibility, but the NIH determined that Abbott met the Bayh-Dole Act criteria.
• Safety Profile: Associated with several side effects and drug interactions that require careful management.
• Recent Applications: Investigated in combination with nirmatrelvir for COVID-19 and PASC treatment.

FAQs

What is NORVIR used for?

NORVIR, or ritonavir, is primarily used in the treatment of HIV/AIDS as a protease inhibitor. It is often used as a booster to enhance the effectiveness of other protease inhibitors.

Who manufactures NORVIR?

NORVIR is manufactured by Abbott Laboratories, now known as AbbVie.

What were the concerns over NORVIR's pricing?

There were concerns raised over the high price of NORVIR, leading to requests for the NIH to exercise its march-in rights under the Bayh-Dole Act. However, the NIH determined that Abbott had met the necessary criteria.

What are the common side effects of NORVIR?

Common side effects include elevations in total cholesterol and triglycerides, new onset or exacerbations of diabetes mellitus, immune reconstitution syndrome, and fat redistribution.

Has NORVIR been used in other clinical contexts?

Yes, NORVIR has been used in combination with nirmatrelvir (Paxlovid) for the treatment of mild to moderate COVID-19 and has been investigated for treating postacute sequelae of SARS-CoV-2 infection (PASC).

What is the current market outlook for NORVIR?

The market for NORVIR continues to be influenced by its role in HIV treatment, regulatory considerations, and its potential applications in other viral infections. Despite the emergence of new treatments, NORVIR remains a significant player in the antiretroviral drug market.

Sources

1. NIH Technology Transfer: "March In Norvir - NIH Technology Transfer"
2. PubMed: "Re-examining the financial burden of boosting with Norvir"
3. JAMA Network: "Nirmatrelvir-Ritonavir and Symptoms in Adults With Postacute Sequelae of SARS-CoV-2 Infection"
4. FDA: "NORVIR (ritonavir) Label"
5. TheBodyPro: "Industry Analysts Project Norvir Sales to Double"