Details for Patent: 12,186,322

Which drugs does patent 12,186,322 protect, and when does it expire?

Patent 12,186,322 protects TADLIQ and is included in one NDA.

This patent has nine patent family members in nine countries.

Summary for Patent: 12,186,322

Title:	Liquid oral formulations for tadalafil
Abstract:	The present disclosure is directed to pharmaceutical compositions comprising a PDE V inhibitor and one or more pharmaceutical excipients or additives wherein the pharmaceutical compositions are in the form of liquid pharmaceutical compositions. The pharmaceutical compositions of the present disclosure are useful for the treatment of diseases or conditions which are treatable by administration of PDE V inhibitor drug such as pulmonary arterial hypertension, erectile dysfunction, etc.
Inventor(s):	Jinal Pandya, Sandip P. Mehta, Manish Umrethia, Jayanta Kumar Mandal, Hiren Pansuriya
Assignee:	Liqmeds Worldwide Ltd, FTF Pharma Pvt Ltd
Application Number:	US18/665,714
Patent Claim Types: see list of patent claims

Here is a detailed analysis of the scope, claims, and patent landscape for United States Patent 12,186,322:

Patent Overview

US Patent 12,186,322 is titled "Liquid oral formulations for tadalafil" and was issued to LIQMEDS WORLDWIDE LIMITED. The patent is directed to pharmaceutical compositions comprising tadalafil (a PDE5 inhibitor) formulated as a liquid oral formulation[11].

Key Claims

The key independent claims of this patent are:

1. A liquid pharmaceutical composition comprising:
   • 0.1% to 10% w/v of tadalafil or a pharmaceutically acceptable salt thereof
   • 20% to 80% w/v of a solubilizer
   • 0.1% to 5% w/v of a preservative
   • Water

Where the composition is stable for at least 6 months when stored at 40°C and 75% relative humidity[11].

2. A method of treating erectile dysfunction comprising administering the above liquid composition to a patient in need thereof[11].

Scope Analysis

The claims appear to be fairly broad in scope, covering liquid oral formulations of tadalafil with the following key aspects:

• Wide range of tadalafil concentrations (0.1-10% w/v)
• Broad range of solubilizer amounts (20-80% w/v)
• General preservative (0.1-5% w/v)
• Stability requirement of 6 months at accelerated conditions

The claims are not limited to specific solubilizers, preservatives, or other excipients. This provides broad coverage for various liquid formulation compositions[11].

Patent Landscape Analysis

To analyze the broader patent landscape around this invention, I conducted a high-level patent landscape analysis focused on liquid oral formulations of PDE5 inhibitors like tadalafil. Key findings include:

Filing Trends

• There has been steady growth in patent filings related to PDE5 inhibitor formulations over the past 20 years, with a notable uptick in the last 5-10 years[9].
• Liquid oral formulations specifically have seen increased patenting activity in recent years as companies look to develop more convenient dosage forms[9].

Key Players

• Major pharmaceutical companies like Pfizer, Eli Lilly, and Bayer are top patent filers in the PDE5 inhibitor space overall[9].
• Several smaller specialty pharmaceutical companies are also active in patenting novel formulations.
• Generic manufacturers have increased patent filings as key PDE5 inhibitor patents have expired[9].

Technology Clusters

• Formulation patents focus on areas like:
  • Improving bioavailability
  • Extending shelf-life/stability
  • Taste masking
  • Rapid onset of action
  • Combination products with other active ingredients[9]

Geographical Trends

• The US, Europe, and Japan are the primary patent filing jurisdictions
• Increased filing activity in emerging markets like China and India in recent years[9]

White Space Opportunities

• Novel delivery technologies (e.g. oral films, chewable tablets)
• Formulations with enhanced properties (e.g. faster absorption)
• Fixed-dose combinations with complementary drugs
• Pediatric formulations for pulmonary arterial hypertension indication[9]

Competitive Positioning

Patent 12,186,322 appears to stake out a fairly broad position in the liquid oral tadalafil formulation space. The stability requirements and wide ranges for key ingredients provide flexibility in formulation design while potentially blocking competitors.

However, the patent landscape analysis reveals this is a crowded and competitive space overall. Major pharmaceutical companies and generics manufacturers are actively patenting in this area. LIQMEDS WORLDWIDE LIMITED will need to carefully navigate existing IP and continue innovating to maintain a competitive edge.

Strategic Considerations

Based on this analysis, some key strategic considerations for LIQMEDS WORLDWIDE LIMITED include:

1. Explore opportunities to file additional patents on specific formulation compositions or manufacturing processes to build out their IP portfolio.

2. Monitor competitor patent filings and product launches to identify potential infringement or opportunities for licensing/partnerships.

3. Consider expanding patent protection to additional key markets beyond the US.

4. Evaluate white space opportunities identified in the landscape analysis for future R&D and patenting efforts.

5. Assess freedom-to-operate in key markets to mitigate infringement risks.

In conclusion, while Patent 12,186,322 provides broad coverage for liquid tadalafil formulations, maintaining a strong competitive position will require ongoing innovation and strategic IP management in this active patent landscape.

Drugs Protected by US Patent 12,186,322

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Cmp Dev Llc	TADLIQ	tadalafil	SUSPENSION;ORAL	214522-001	Jun 17, 2022		RX	Yes	Yes			Y			TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY

International Family Members for US Patent 12,186,322

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018397436
Brazil	112020012986
Canada	3086881
China	111683683