Details for Patent: 12,171,883

Which drugs does patent 12,171,883 protect, and when does it expire?

Patent 12,171,883 protects TARPEYO and is included in one NDA.

This patent has twelve patent family members in nine countries.

Summary for Patent: 12,171,883

Title:	Pharmaceutical compositions
Abstract:	The present invention provides for a method of treatment of IgA nephropathy, which method comprises: (i) identifying a pharmaceutically acceptable composition intended to treat IgA nephropathy comprising budesonide and one or more pharmaceutically-acceptable excipients that provide for a modified release of said budesonide after administration to the gastrointestinal tract, which composition fulfils the following requirements in a standard in vitro USP<711>/Ph.Eur. 2.9.3 dissolution test using a dissolution apparatus according to Apparatus 2 (Paddle Apparatus) of said test; (a) the composition fulfils the requirement that no more than about 10% of the budesonide is released into the dissolution medium within about 120 minutes, when the dissolution medium is aqueous and has a pH of about 1.2; (b) the composition fulfils the requirement that no more than about 10% of the budesonide is released into a pharmaceutically-relevant dissolution medium within about 30 minutes; and (c) the composition fulfils the requirement that at least about 70% of the budesonide is released into the pharmaceutically-relevant dissolution medium within about 120 minutes; (ii) wherein the method comprises the step of administering said composition to a patient with IgA nephropathy in need of said treatment.
Inventor(s):	Eva Kristina RIESEL, Lena Margareta PERESWETOFF-MORATH, Kari SANDVOLD, Christian Olle Andreas PEDERSEN
Assignee:	Calliditas Therapeutics AB
Application Number:	US18/392,666
Patent Claim Types: see list of patent claims

Here is a detailed analysis of the scope, claims, and patent landscape for United States Patent 12,171,883:

Patent Overview

United States Patent 12,171,883 does not appear to be a valid patent number. U.S. utility patent numbers currently only go up to about 11.8 million. Without a valid patent number to analyze, I'll provide a general overview of how to analyze patent scope, claims and landscape:

Analyzing Patent Scope and Claims

To analyze the scope and claims of a patent:

1. Review the independent claims, which define the broadest scope of the invention. Focus on the key elements and limitations.

2. Examine dependent claims, which narrow the scope by adding additional limitations.

3. Look at the specification and drawings to interpret claim terms and understand the full context of the invention.

4. Consider the prosecution history to see how claims were amended or argued during examination.

5. Evaluate the breadth of the claims - are they narrow and specific or broad and general?

6. Identify any means-plus-function claim elements, which can impact claim scope.

7. Note any product-by-process claims, which are limited by the recited process steps.

8. Assess how the claims align with the described embodiments and stated objectives of the invention.

Patent Landscape Analysis

To analyze the patent landscape around an invention:

1. Conduct keyword and classification searches to identify related patents and applications.

2. Review citing and cited patents to understand the technological context.

3. Analyze filing trends over time in the technology area.

4. Identify key assignees/inventors active in the space.

5. Look for white space or gaps in patent coverage.

6. Evaluate geographical filing patterns.

7. Consider how the claims compare to other patents in the field.

8. Assess freedom to operate based on active patents.

9. Identify potential licensing opportunities or litigation risks.

10. Analyze rejection rates and prosecution trends for similar applications.

Key Considerations

When evaluating patent scope and landscape:

• Broader claims provide wider protection but may be more vulnerable to invalidity challenges.

• Narrow claims offer more limited protection but are generally stronger against prior art.

• The specification should provide adequate support for the full scope of the claims.

• File history estoppel can limit claim scope based on arguments made during prosecution.

• Continuation applications can be used to pursue broader claims.

• International filings expand geographical protection but increase costs.

• Crowded fields may require more narrow claiming to overcome prior art.

• Emerging technologies often allow for broader initial patent coverage.

Conclusion

Without a specific patent to analyze, this overview provides a general framework for evaluating patent scope, claims and landscape. A thorough analysis requires reviewing the full patent document, file history, and related prior art to understand the true scope and context of the claimed invention. Patent landscape studies involve extensive searching and data analysis to map out the competitive and technological environment.

Drugs Protected by US Patent 12,171,883

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes			Y

International Family Members for US Patent 12,171,883

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2023210461
China	118591376
Colombia	2024009565