Details for Patent: 9,192,606

Which drugs does patent 9,192,606 protect, and when does it expire?

Patent 9,192,606 protects ORKAMBI and is included in two NDAs.

This patent has thirteen patent family members in thirteen countries.

Summary for Patent: 9,192,606

Title:	Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid
Abstract:	The present invention relates to formulations of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl)benzoic acid in Form I, pharmaceutical packs or kits thereof, and methods of treatment therewith.
Inventor(s):	Young; Christopher (Sudbury, MA)
Assignee:	Vertex Pharmaceuticals Incorporated (Boston, MA)
Application Number:	14/219,154
Patent Claim Types: see list of patent claims	Compound; Dosage form; Composition; Use; Device;

Understanding the Scope and Claims of United States Patent 9,192,606

Introduction

United States Patent 9,192,606, titled "Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid," is a patent held by Vertex Pharmaceuticals Inc. and is crucial in the treatment of cystic fibrosis. Here, we will delve into the scope, claims, and the broader patent landscape surrounding this invention.

Patent Overview

The patent in question pertains to specific dosage units of a combination therapy involving lumacaftor and ivacaftor, which are used to treat cystic fibrosis (CF) in patients who are homozygous for the F508del mutation in the CFTR gene. This mutation is the most common cause of CF, a genetic disorder that affects the respiratory, digestive, and reproductive systems.

Patented Use

The patented use of this invention is specifically for the treatment of cystic fibrosis in patients aged 1 to 5 years and 6 years and older who have the F508del mutation. The dosage units are designed to administer an effective amount of lumacaftor and ivacaftor, which are modulators of the CFTR protein[1].

Claims

The patent includes several claims that define the scope of the invention:

Composition Claims

• The patent claims specific compositions comprising lumacaftor and ivacaftor in defined dosage units. These compositions are tailored to ensure the effective delivery of the active ingredients to patients with cystic fibrosis[1].

Method of Treatment Claims

• The patent also claims methods of treating cystic fibrosis using these specific dosage units. This includes administering the combination therapy to patients with the F508del mutation to improve CFTR protein function[1].

Dosage Unit Claims

• The claims specify the exact formulation and dosage of the combination therapy, ensuring that each unit contains a precise amount of lumacaftor and ivacaftor. This precision is critical for the efficacy and safety of the treatment[1].

Patent Landscape

International and US Patents

• The patent landscape for cystic fibrosis treatments is complex, with numerous international and US patents. Vertex Pharmaceuticals holds a significant number of these patents, including US Patent 9,192,606, which is part of a larger portfolio of patents related to CFTR modulators[1].

Related Patents

• Other patents, such as US Patent 7,495,103 and US Patent 7,973,038, also relate to modulators of ATP-binding cassette transporters, which include the CFTR protein. These patents cover various aspects of the treatment, including different formulations and methods of administration[1].

Exclusivity and Generic Entry

• The patent exclusivity period for Orkambi, the drug that combines lumacaftor and ivacaftor, is a critical factor in the patent landscape. As the patents expire, generic alternatives may enter the market, potentially changing the competitive landscape for CF treatments[1].

Impact on Cystic Fibrosis Treatment

The invention covered by US Patent 9,192,606 has significantly improved the treatment options for patients with cystic fibrosis. Here are some key points:

Clinical Trials

• The combination therapy of lumacaftor and ivacaftor has undergone extensive clinical trials, demonstrating its efficacy in improving lung function and reducing pulmonary exacerbations in patients with the F508del mutation[1].

Regulatory Approval

• The FDA has approved this combination therapy for use in patients aged 1 to 5 years and 6 years and older, reflecting the robust clinical data supporting its safety and efficacy[1].

Patient Outcomes

• Patients treated with this combination therapy have shown improved lung function and quality of life, highlighting the importance of this patent in advancing CF treatment[1].

Economic and Market Impact

The patent has substantial economic and market implications:

Market Dominance

• Vertex Pharmaceuticals, with its portfolio of CF-related patents, including US Patent 9,192,606, holds a dominant position in the cystic fibrosis treatment market. This dominance is expected to continue until the patents expire and generic alternatives become available[1].

Revenue

• The sales of Orkambi, the drug covered by this patent, have been significant, contributing substantially to Vertex Pharmaceuticals' revenue. The patent's exclusivity period has protected this revenue stream from generic competition[1].

Future Outlook

As the patent landscape evolves, several factors will influence the future of cystic fibrosis treatment:

Patent Expiration

• The expiration of key patents, including US Patent 9,192,606, will open the market to generic alternatives, potentially reducing treatment costs and increasing access to these life-saving medications[1].

New Innovations

• Ongoing research and development in CFTR modulators and other treatments for cystic fibrosis may lead to new innovations and patents, further expanding treatment options for patients[1].

Key Takeaways

• Patent Scope: US Patent 9,192,606 covers specific dosage units of lumacaftor and ivacaftor for treating cystic fibrosis in patients with the F508del mutation.
• Claims: The patent includes claims related to the composition, method of treatment, and dosage units of the combination therapy.
• Impact: The patent has significantly improved treatment options for cystic fibrosis patients and holds a dominant market position.
• Future Outlook: The expiration of this and related patents will influence the market, potentially leading to generic entry and new innovations.

FAQs

1. What is the primary use of US Patent 9,192,606?

   • The primary use is for the treatment of cystic fibrosis in patients aged 1 to 5 years and 6 years and older who are homozygous for the F508del mutation in the CFTR gene.

2. What are the active ingredients covered by this patent?

   • The active ingredients are lumacaftor and ivacaftor, which are CFTR modulators.

3. When do the patents related to Orkambi expire?

   • The exact expiration dates are not publicly available without a subscription, but the patents are set to expire in the coming years, allowing for potential generic entry.

4. How has this patent impacted cystic fibrosis treatment?

   • It has significantly improved treatment options by providing an effective combination therapy that improves lung function and reduces pulmonary exacerbations.

5. What is the market impact of this patent?

   • The patent has allowed Vertex Pharmaceuticals to maintain a dominant market position in cystic fibrosis treatments, protecting revenue from generic competition until the patents expire.

Sources

1. DrugPatentWatch - ORKAMBI Market Exclusivity Period (MEP).
2. Unified Patents - US-20130281487-A1.
3. USPTO - Patent Claims Research Dataset.
4. USPTO - Search for patents.
5. PubChem - 5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3.

Drugs Protected by US Patent 9,192,606

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-003	Sep 2, 2022		RX	Yes	No			Y			TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 1-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AND IVACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 9192606
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-001	Aug 7, 2018		RX	Yes	No			Y			TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AND IVACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 9192606
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	GRANULE;ORAL	211358-002	Aug 7, 2018		RX	Yes	Yes			Y			TREATMENT OF CYSTIC FIBROSIS IN A PATIENT AGE 2-5 YEARS WHO IS HOMOZYGOUS FOR THE F508DEL MUTATION IN THE CFTR GENE USING THE DOSAGE UNIT COMPRISING LUMACAFTOR AND IVACAFTOR AS RECITED IN CLAIM 1 OF US PATENT 9192606
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-002	Sep 28, 2016		RX	Yes	No			Y			METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING A DOSAGE UNIT AS DEFINED IN CLAIM 1 OF U.S. PATENT NO. 9,192,606
Vertex Pharms Inc	ORKAMBI	ivacaftor; lumacaftor	TABLET;ORAL	206038-001	Jul 2, 2015		RX	Yes	Yes			Y			METHOD OF TREATING CYSTIC FIBROSIS IN A PATIENT, THE PATIENT HAVING THE F508DEL MUTATION IN CFTR, USING A DOSAGE UNIT AS DEFINED IN CLAIM 1 OF U.S. PATENT NO. 9,192,606

International Family Members for US Patent 9,192,606

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	073709
Australia	2009296271
Brazil	PI0919550
Canada	2736545
Chile	2011000642