Details for Patent: 11,382,917

Which drugs does patent 11,382,917 protect, and when does it expire?

Patent 11,382,917 protects TADLIQ and is included in one NDA.

This patent has nine patent family members in nine countries.

Summary for Patent: 11,382,917

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):	Pandya; Jinal (Unjha, IN), Mehta; Sandip P. (Ahmedabad, IN), Umrethia; Manish (Ahmedabad, IN), Mandal; Jayanta Kumar (Ahmedabad, IN), Pansuriya; Hiren (Ahmedabad, IN)
Assignee:	LIQMEDS WORLDWIDE LIMITED (Haynes, GB)
Application Number:	17/403,282
Patent Claim Types: see list of patent claims	Use; Composition;

Detailed Analysis of the Scope and Claims of United States Patent 11,382,917

Overview of the Patent

United States Patent 11,382,917, titled "Liquid oral formulations for tadalafil," is a significant development in the field of pharmaceuticals, particularly for the treatment of conditions such as erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension. Here is a comprehensive analysis of the patent's scope, claims, and the surrounding patent landscape.

Inventors and Assignee

The patent was invented by Jinal Pandya, Sandip P. Mehta, Manish Umrethia, Jayanta Kumar Mandal, and Hiren Pansuriya, all from India. The assignee of the patent is LIQMEDS WORLDWIDE LIMITED, based in Haynes, UK[2].

Patent Claims

The patent claims are centered around pharmaceutical compositions that include a phosphodiesterase 5 (PDE5) inhibitor, specifically tadalafil, and one or more pharmaceutical excipients or additives. These compositions are formulated as liquid oral dosages.

• Composition Claims: The patent specifies the formulation of tadalafil in a liquid oral form, which includes the active pharmaceutical ingredient (API) and various excipients to enhance stability, solubility, and bioavailability[1][2].
• Use Claims: The patent covers the use of these liquid oral formulations for treating diseases or conditions that are responsive to PDE5 inhibitors, such as erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension[2].

Pharmaceutical Formulation

The patent addresses several key challenges in developing oral liquid dosage forms:

• Stability: Ensuring the stability of tadalafil in solution is crucial. The formulation must prevent degradation of the API over time[1].
• Solubility: Achieving the required level of solubility for tadalafil is another significant challenge. The patent discloses various excipients and additives that enhance solubility without compromising stability[1].

Therapeutic Uses

The liquid oral formulations of tadalafil are indicated for several therapeutic uses:

• Erectile Dysfunction: Tadalafil is well-known for its efficacy in treating erectile dysfunction by increasing blood flow to the penis[4].
• Benign Prostatic Hyperplasia: The drug is also used to treat symptoms of an enlarged prostate[4].
• Pulmonary Arterial Hypertension: Tadalafil helps in reducing high blood pressure in the lungs, improving exercise ability in patients with PAH (WHO Group 1)[2].

Patent Landscape

Patent Family and Global Coverage

The patent has a significant global footprint with nine patent family members in nine countries, including India, Australia, Brazil, and Canada. This extensive coverage ensures broad protection for the invention across various jurisdictions[2].

Expiration Dates

The patent is set to expire on December 24, 2038, which provides a substantial period of exclusivity for the patent holder. This expiration date is consistent across related patents such as 11,666,576 and 11,975,006[5].

Related Patents

There are several related patents that cover different aspects of tadalafil formulations and uses. However, as of the current date, there is no therapeutically equivalent version of Tadliq (the branded product protected by this patent) available in the United States[5].

Regulatory Approval

The liquid oral formulation of tadalafil, branded as TADLIQ, has received regulatory approval. It is indicated for the treatment of pulmonary arterial hypertension (PAH) to improve exercise ability and is classified as an RX (prescription-only) medication[2].

Market Impact

The approval and patent protection of TADLIQ signify a significant market opportunity for LIQMEDS WORLDWIDE LIMITED. The liquid oral formulation offers a convenient and potentially more bioavailable alternative to traditional tablet forms, which could enhance patient compliance and treatment outcomes.

Competitive Landscape

The absence of a therapeutically equivalent generic version in the U.S. market gives TADLIQ a competitive edge. However, the patent landscape is dynamic, and future developments or challenges to the patent could alter the competitive scenario.

Conclusion

United States Patent 11,382,917 represents a critical advancement in the formulation of tadalafil, addressing key challenges in stability and solubility. The patent's broad claims and extensive global coverage ensure strong intellectual property protection, positioning TADLIQ as a significant player in the treatment of erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension.

Key Takeaways

• Innovative Formulation: The patent introduces a liquid oral formulation of tadalafil, overcoming stability and solubility challenges.
• Therapeutic Uses: The formulation is indicated for erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension.
• Global Coverage: The patent has a broad global footprint with nine patent family members.
• Exclusivity: The patent expires on December 24, 2038, providing a long period of exclusivity.
• Regulatory Approval: TADLIQ has received regulatory approval for the treatment of PAH.

FAQs

1. What is the main focus of United States Patent 11,382,917?

   • The patent focuses on liquid oral formulations of tadalafil, a PDE5 inhibitor, for treating conditions like erectile dysfunction, benign prostatic hyperplasia, and pulmonary arterial hypertension.

2. Who are the inventors of this patent?

   • The inventors are Jinal Pandya, Sandip P. Mehta, Manish Umrethia, Jayanta Kumar Mandal, and Hiren Pansuriya.

3. What are the key challenges addressed in this patent?

   • The patent addresses the stability and solubility of tadalafil in liquid oral formulations.

4. Is there a generic version of TADLIQ available in the U.S.?

   • As of the current date, there is no therapeutically equivalent generic version of TADLIQ available in the United States.

5. When does the patent expire?

   • The patent is set to expire on December 24, 2038.

Sources

1. US11382917B2 - Liquid oral formulations for tadalafil - Google Patents
2. Pharmaceutical drugs covered by patent 11,382,917. Claims ... - DrugPatentWatch
3. New Frontiers in the Strategic Use of Patent Information - PatAnalyse
4. Tadalafil: Uses, Interactions, Mechanism of Action | DrugBank Online
5. Generic Tadliq Availability - Drugs.com

Drugs Protected by US Patent 11,382,917

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	11,382,917		Y			TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY

Foreign Priority and PCT Information for Patent: 11,382,917

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
India	201721046640	Dec 26, 2017
India	201821012438	Apr 2, 2018

International Family Members for US Patent 11,382,917

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018397436
Brazil	112020012986
Canada	3086881
China	111683683
European Patent Office	3731870
Japan	2021509114