Details for Patent: 8,664,231

Which drugs does patent 8,664,231 protect, and when does it expire?

Patent 8,664,231 protects RASUVO and is included in one NDA.

This patent has twenty-nine patent family members in twenty-one countries.

Summary for Patent: 8,664,231

Title:	Concentrated methotrexate solutions
Abstract:	Concentrated methotrexate solutions are described which are suitable for the use of an active substance in the production of a parenterally administered medicament for the treatment of inflammatory autoimmune diseases. The methotrexate is added to a pharmaceutically acceptable solvent at a concentration of more than 30 mg/ml. The invention also relates to a ready-made syringe and a carpule containing such a pharmaceutical solution formulation, as well as a pen injector comprising such a carpule and/or a ready-made syringe.
Inventor(s):	Will; Heiner (Hamburg, DE)
Assignee:	Medac Gesellschaft fuer Klinische Spezialpraepararate mbH (Wedel, DE)
Application Number:	12/374,528
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,664,231
Patent Claim Types: see list of patent claims	Use; Formulation; Device; Dosage form;

United States Patent 8,664,231: A Detailed Analysis of Scope, Claims, and Patent Landscape

Introduction

United States Patent 8,664,231, titled "Concentrated methotrexate solutions," is a significant patent in the pharmaceutical industry, particularly for the treatment of inflammatory autoimmune diseases. This patent, assigned to Medac Gesellschaft fuer Klinische Spezialpraeparate mbH, protects the formulation and administration methods of concentrated methotrexate solutions.

Inventor and Assignee

The patent was invented by Heiner Will and is assigned to Medac Gesellschaft fuer Klinische Spezialpraeparate mbH, a German pharmaceutical company[2][3].

Patent Summary

The patent describes concentrated methotrexate solutions suitable for parenteral administration, specifically for treating inflammatory autoimmune diseases. The methotrexate is dissolved in a pharmaceutically acceptable solvent at a concentration of more than 30 mg/ml. The invention also includes ready-made syringes, carpules, and pen injectors containing these solutions[1][2][4].

Claims

The patent includes various claims that cover different aspects of the invention:

• Use Claims: The use of concentrated methotrexate solutions for treating inflammatory autoimmune diseases.
• Formulation Claims: The specific concentration of methotrexate in a pharmaceutically acceptable solvent.
• Device Claims: Ready-made syringes, carpules, and pen injectors containing the concentrated methotrexate solutions.
• Dosage Form Claims: The specific formulation and presentation of the methotrexate solutions for subcutaneous injection[1][2][4].

Patent Expiration

The patent is set to expire on June 1, 2029. This expiration date is crucial as it determines when generic versions of the drug can enter the market. However, the actual expiration date may be influenced by legal activities such as patent litigation, term extensions, or amendments to the patent claims[2][3].

Patent Litigation and PTAB Cases

The patent has been involved in several legal activities, including inter partes review (IPR) proceedings. For instance, Koios Pharmaceuticals LLC filed a petition for an IPR of claims 1–22 of the patent in 2016. These legal activities can impact the patent's validity and expiration date[3][5].

Foreign Priority and PCT Information

The patent has international protection with twenty-nine patent family members in twenty-one countries. It was filed under the Patent Cooperation Treaty (PCT) with the application number PCT/EP2007/006491 and was published as WO2008/009476 on January 24, 2008[1].

Generic Availability

As of now, there is no therapeutically equivalent generic version of Rasuvo (the branded drug protected by this patent) available in the United States. The lack of generic competition is directly tied to the patent's active status and the absence of any approved generic equivalents[2].

Diseases Treated

The concentrated methotrexate solutions protected by this patent are used to treat a variety of inflammatory autoimmune diseases, including:

• Rheumatoid arthritis
• Psoriasis
• Ankylosing spondylitis
• Juvenile idiopathic arthritis
• Vasculitis
• Crohn's disease
• Multiple sclerosis
• Osteoarthritis These conditions highlight the broad therapeutic application of the patented formulation[4].

Patent Landscape

The patent landscape surrounding U.S. Patent 8,664,231 is complex due to the ongoing legal activities and the international scope of the patent. Here are some key points:

• International Protection: The patent has extensive international coverage, ensuring that the formulation is protected in multiple jurisdictions.
• Litigation and IPR: The patent has been subject to various legal challenges, which can affect its validity and expiration.
• Generic Competition: The absence of generic versions until the patent expires in 2029 gives the patent holder exclusive market rights for the protected formulation[1][3].

Impact on the Pharmaceutical Industry

This patent significantly impacts the pharmaceutical industry by:

• Protecting Innovation: It ensures that the innovative formulation of concentrated methotrexate solutions remains exclusive to the patent holder, encouraging further research and development.
• Market Exclusivity: The patent prevents generic competition, allowing the patent holder to maintain market share and pricing control until the patent expires.
• Therapeutic Benefits: The protected formulation provides a specific and effective treatment option for patients with inflammatory autoimmune diseases[2][4].

Key Takeaways

• Patent Protection: U.S. Patent 8,664,231 protects concentrated methotrexate solutions for treating inflammatory autoimmune diseases.
• Expiration Date: The patent is set to expire on June 1, 2029, subject to legal activities.
• International Coverage: The patent has extensive international protection.
• No Generic Versions: Currently, no generic versions of Rasuvo are available in the U.S.
• Therapeutic Applications: The patented formulation treats various autoimmune diseases.

FAQs

Q: What is the main subject of U.S. Patent 8,664,231?

A: The patent covers concentrated methotrexate solutions suitable for parenteral administration, specifically for treating inflammatory autoimmune diseases.

Q: Who is the assignee of this patent?

A: The patent is assigned to Medac Gesellschaft fuer Klinische Spezialpraeparate mbH.

Q: When is the patent set to expire?

A: The patent is set to expire on June 1, 2029, but this date may be affected by ongoing legal activities.

Q: Are there any generic versions of Rasuvo available?

A: No, there are currently no therapeutically equivalent generic versions of Rasuvo available in the United States.

Q: What diseases are treated by the formulation protected by this patent?

A: The formulation is used to treat various inflammatory autoimmune diseases, including rheumatoid arthritis, psoriasis, and ankylosing spondylitis, among others.

Cited Sources:

1. Drug Patent Watch - Summary for Patent: 8,664,231
2. Drugs.com - Generic Rasuvo Availability
3. Pharsight - Rasuvo patent expiration
4. Google Patents - US8664231B2 - Concentrated methotrexate solutions
5. Patent Docs - [e-mail] Paper No. 13 571.272.7822 Entered

Drugs Protected by US Patent 8,664,231

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-001	Jul 10, 2014		RX	Yes	Yes						SUBCUTANEOUS INJECTION OF METHOTREXATE
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-002	Jul 10, 2014		RX	Yes	Yes						SUBCUTANEOUS INJECTION OF METHOTREXATE
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-003	Jul 10, 2014		RX	Yes	Yes						SUBCUTANEOUS INJECTION OF METHOTREXATE
Medexus	RASUVO	methotrexate	SOLUTION;SUBCUTANEOUS	205776-004	Jul 10, 2014		RX	Yes	Yes						SUBCUTANEOUS INJECTION OF METHOTREXATE

Foreign Priority and PCT Information for Patent: 8,664,231

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	10 2006 033 837	Jul 21, 2006

PCT Information
PCT Filed	July 20, 2007	PCT Application Number:	PCT/EP2007/006491
PCT Publication Date:	January 24, 2008	PCT Publication Number:	WO2008/009476

International Family Members for US Patent 8,664,231

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	14872
Austria	E491455
Australia	2007276387
Brazil	PI0715433