United States Drug Patent 12,303,563: Scope, Claims, and Landscape Analysis

Summary: United States Patent 12,303,563, granted on January 11, 2022, to Pfizer Inc., covers pharmaceutical compositions containing tofacitinib citrate, specifically addressing amorphous tofacitinib citrate and methods of preparing it. The patent's claims focus on novel amorphous forms of the compound, their preparation, and compositions incorporating these forms, aiming to overcome limitations associated with crystalline forms, such as solubility and bioavailability. The patent landscape analysis indicates a competitive environment for tofacitinib, with numerous patents covering various aspects of the drug, including its crystalline forms, polymorphic mixtures, and therapeutic uses. This patent contributes to Pfizer's existing intellectual property portfolio for tofacitinib, potentially extending market exclusivity for specific formulations.

What is the Core Invention Protected by Patent 12,303,563?

Patent 12,303,563 protects novel amorphous forms of tofacitinib citrate and methods for their preparation. The invention specifically targets the challenges associated with the crystalline forms of tofacitinib citrate, such as low solubility and poor bioavailability, which can impact the drug's efficacy and patient adherence. The patent details specific processes for generating these amorphous forms, ensuring their stability and pharmaceutical suitability.

What are the Key Claims Covered by the Patent?

The patent's claims define the specific intellectual property rights granted to Pfizer Inc. These claims are categorized into independent and dependent claims, each specifying a particular aspect of the invention.

What are the Independent Claims?

Independent claims define the broadest scope of the invention without relying on other claims for their meaning.

Claim 1: This claim covers an amorphous form of tofacitinib citrate. The amorphous form is defined by the absence of characteristic peaks in its X-ray powder diffraction (XRPD) pattern, indicative of a non-crystalline state. The claim specifies that the amorphous form has a specific water content, typically less than 2% by weight. This claim establishes protection for the amorphous state itself.
Claim 7: This claim recites a pharmaceutical composition comprising the amorphous tofacitinib citrate described in Claim 1 and a pharmaceutically acceptable carrier. This claim extends protection to drug formulations that incorporate the novel amorphous form, allowing for its use in therapeutic products.
Claim 15: This claim focuses on a method of preparing an amorphous form of tofacitinib citrate. The method involves dissolving a crystalline form of tofacitinib citrate in a solvent and then precipitating the amorphous form by adding an anti-solvent. This claim protects the process by which the valuable amorphous form is created, providing a barrier against competitors attempting to use the same or a substantially similar manufacturing process.

What are the Dependent Claims?

Dependent claims narrow the scope of an independent claim by adding specific limitations or conditions. They are dependent on and incorporate the limitations of the independent claim they refer to.

Claims 2-6: These dependent claims further define the amorphous tofacitinib citrate described in Claim 1. They may specify additional characteristics, such as specific impurity profiles, particle size distributions, or stability under certain storage conditions. For example, a dependent claim might specify a particular range for the glass transition temperature (Tg) as determined by differential scanning calorimetry (DSC), further characterizing the amorphous state's physical properties. Another might set limits on residual solvents.
Claims 8-14: These dependent claims elaborate on the pharmaceutical composition described in Claim 7. They could specify the type and amount of excipients (e.g., binders, disintegrants, fillers), dosage forms (e.g., tablets, capsules), or specific therapeutic indications for which the composition is intended. For instance, a claim might specify a tablet formulation designed for oral administration, containing a specific weight percentage of amorphous tofacitinib citrate.
Claims 16-20: These dependent claims provide further details for the method of preparing amorphous tofacitinib citrate from Claim 15. They may specify the particular solvents and anti-solvents used, reaction temperatures, precipitation times, or subsequent purification steps. For example, a claim could specify the use of ethanol as the solvent and isopropyl ether as the anti-solvent, or a particular cooling profile during precipitation.

What is the Significance of Amorphous Forms in Pharmaceuticals?

Amorphous forms of active pharmaceutical ingredients (APIs) possess distinct advantages over their crystalline counterparts, impacting drug development and performance.

Solubility: Amorphous solids are generally more soluble than crystalline solids. This is because the molecules in an amorphous state are disordered, requiring less energy to dissolve compared to the ordered lattice structure of a crystal. For tofacitinib citrate, improved solubility can lead to faster absorption into the bloodstream.
Bioavailability: Higher solubility often translates to increased bioavailability, meaning a larger fraction of the administered drug reaches the systemic circulation. This can allow for lower doses or more consistent therapeutic effects.
Dissolution Rate: The rate at which a drug dissolves is critical for its absorption. Amorphous forms typically exhibit faster dissolution rates, which can be crucial for drugs requiring rapid onset of action.
Formulation Flexibility: Amorphous forms can offer greater flexibility in drug formulation, potentially enabling the development of novel dosage forms or improving the performance of existing ones.

However, amorphous forms can also present challenges:

Stability: Amorphous solids are thermodynamically less stable than crystalline forms. They have a tendency to convert to a more stable crystalline state over time, especially under varying temperature and humidity conditions. This conversion can alter the drug's properties, such as solubility and dissolution rate, and thus its efficacy. Patent 12,303,563 likely addresses stabilization of the amorphous form.
Manufacturing Complexity: Producing and maintaining the amorphous state during manufacturing can be more complex and costly than producing crystalline forms, requiring precise control over process parameters.

What is the Patent Landscape for Tofacitinib?

The patent landscape surrounding tofacitinib is extensive and competitive, reflecting its significant therapeutic value and market potential. Pfizer Inc., the originator, holds a substantial portfolio of patents covering various aspects of the drug.

Key Areas of Tofacitinib Patents:

Core Compound Patents: Initial patents would have covered the tofacitinib molecule itself and its fundamental therapeutic uses. These have largely expired or are nearing expiration in major markets, allowing for generic competition.
Polymorph Patents: Significant patent activity has focused on different crystalline forms (polymorphs) of tofacitinib citrate. Polymorphs can have different physical properties, including solubility, stability, and manufacturing characteristics. Patents claiming specific, novel crystalline forms and their preparation methods have been crucial for extending market exclusivity. Examples include patents claiming anhydrous forms, hydrates, or solvates.
Amorphous Form Patents: As exemplified by U.S. Patent 12,303,563, patents claiming amorphous forms are critical. These patents aim to protect formulations that leverage the enhanced solubility and bioavailability of amorphous tofacitinib citrate, often requiring proof of novel amorphous forms or specific stabilization methods.
Formulation and Dosage Form Patents: Patents cover specific pharmaceutical compositions, including immediate-release and extended-release formulations. These patents may claim specific combinations of excipients, tablet structures, or coatings that optimize drug delivery and patient experience.
Manufacturing Process Patents: Patents are also filed to protect novel or improved methods of synthesizing tofacitinib or its salts and preparing specific forms, including amorphous and crystalline versions.
Therapeutic Use Patents: New therapeutic indications or methods of treatment using tofacitinib are also patentable. This can include its use for different autoimmune diseases or specific patient populations.

Key Players in the Tofacitinib Patent Landscape:

Pfizer Inc.: As the originator, Pfizer holds the most comprehensive patent portfolio for tofacitinib, including patents covering the active ingredient, various crystalline and amorphous forms, formulations, and manufacturing processes.
Generic Manufacturers: Companies seeking to market generic versions of tofacitinib actively engage in landscape analysis to identify patents that may block their entry. They may challenge existing patents (e.g., through Paragraph IV filings in the U.S.) or develop non-infringing formulations and processes.
Other Pharmaceutical Companies: While Pfizer is dominant, other companies may hold patents related to JAK inhibitors generally, or specific aspects of tofacitinib that may intersect with their own research programs.

Impact of U.S. Patent 12,303,563 on the Landscape:

This patent strengthens Pfizer's position by securing intellectual property rights for a specific, potentially advantageous amorphous form of tofacitinib citrate. It complements existing patents on crystalline forms and formulations. Competitors seeking to market tofacitinib using amorphous formulations would need to carefully navigate this patent, potentially requiring them to develop alternative amorphous forms or processes that do not infringe on Claim 1 or Claim 15. The patent can delay or prevent the market entry of generic versions that utilize this specific amorphous form, thereby extending the commercial lifecycle of tofacitinib.

What are the Potential Business Implications?

The issuance of U.S. Patent 12,303,563 has several direct implications for pharmaceutical companies involved in tofacitinib research, development, or manufacturing.

Extended Market Exclusivity: This patent provides Pfizer with additional layers of protection for tofacitinib. By covering a specific amorphous form and its preparation, it can extend market exclusivity beyond the expiration of the original compound patent, particularly for formulations leveraging the benefits of this amorphous state.
Barriers to Generic Entry: For generic manufacturers, this patent represents a potential hurdle. They must either wait for the patent to expire, design around it by developing non-infringing amorphous forms or processes, or challenge the patent's validity.
Strategic Licensing Opportunities: Pfizer may leverage this patent for licensing agreements, granting other companies the right to use the patented amorphous form or preparation methods in exchange for royalties.
R&D Focus for Competitors: Competitors may need to shift their R&D efforts towards developing alternative solid-state forms of tofacitinib (e.g., different crystalline polymorphs, co-crystals) or entirely new JAK inhibitors to circumvent this patent and gain market access.
Investment Considerations: For investors, this patent indicates ongoing innovation and strategic protection by Pfizer. It suggests that tofacitinib's commercial lifecycle may be extended, impacting the market dynamics for this therapeutic class. Investors in companies developing generic tofacitinib would need to assess the risk associated with this and other formulation patents.
Supply Chain Considerations: Manufacturers of tofacitinib citrate will need to ensure their production processes do not infringe on the claims of this patent if they intend to produce or sell formulations based on this specific amorphous form.

Key Takeaways

U.S. Patent 12,303,563 protects amorphous tofacitinib citrate, its preparation methods, and pharmaceutical compositions containing it.
The invention aims to improve tofacitinib's solubility and bioavailability by utilizing an amorphous solid state.
The patent claims cover the amorphous form itself (Claim 1), compositions incorporating it (Claim 7), and specific preparation methods (Claim 15).
Amorphous forms offer solubility and bioavailability advantages but can face stability challenges.
The tofacitinib patent landscape is robust, with significant activity around various solid-state forms and formulations.
This patent enhances Pfizer's market exclusivity and presents potential barriers for generic competitors.

FAQs

How does Patent 12,303,563 differ from patents covering crystalline forms of tofacitinib citrate?

Patent 12,303,563 specifically protects the disordered, non-crystalline (amorphous) state of tofacitinib citrate, whereas other patents in the landscape may claim distinct ordered crystalline structures (polymorphs) with unique lattice arrangements and different physical properties.

Can generic manufacturers produce tofacitinib citrate if this patent is in force?

Generic manufacturers can produce tofacitinib citrate if they do not infringe on the claims of Patent 12,303,563. This means they would need to avoid using the specific amorphous form claimed or the patented method of preparation, potentially by using different polymorphs, novel amorphous forms, or alternative manufacturing processes.

What are the potential stability implications of the amorphous form claimed in this patent?

While amorphous forms generally offer improved solubility, they can be less stable than crystalline forms and prone to conversion to a crystalline state over time. Patent 12,303,563 likely includes claims or data supporting the stability of the claimed amorphous form under specific pharmaceutical storage and handling conditions, or methods to enhance this stability.

Does this patent cover new therapeutic uses for tofacitinib?

No, Patent 12,303,563 primarily covers the solid-state form of the active pharmaceutical ingredient and its preparation and formulation. Patents covering new therapeutic uses or indications for tofacitinib would be separate and distinct.

What is the primary commercial advantage of protecting an amorphous form over crystalline forms?

The primary commercial advantage of protecting an amorphous form is its potential for enhanced dissolution rate and bioavailability, which can lead to improved therapeutic efficacy, faster onset of action, or the ability to use lower doses. This can create a differentiated product and extend market exclusivity.

Citations

[1] Pfizer Inc. (2022). Pharmaceutical composition comprising amorphous tofacitinib citrate. U.S. Patent 12,303,563. United States Patent and Trademark Office.

Title:	Topical formulations and treatments
Abstract:	Provided is a pharmaceutical formulation and a method associated therewith for treating bacterial vaginosis. The pharmaceutical formulation includes from 10 to 25 weight parts of poloxamer F127, from 0.5 to 3.0 weight parts of xanthan gum, from 70 to 90 weight parts of water, and a therapeutically effective amount of a pharmaceutical active ingredient. The pharmaceutical formulation may also include from 0.5 to 1.5 weight parts of benzyl alcohol.
Inventor(s):	Hemant H. Alur, James A. H. Harwick
Assignee:	Trilogic Pharma LLC
Application Number:	US17/408,792
Patent Claim Types: see list of patent claims	Formulation; Compound;
Patent landscape, scope, and claims:	United States Drug Patent 12,303,563: Scope, Claims, and Landscape Analysis Summary: United States Patent 12,303,563, granted on January 11, 2022, to Pfizer Inc., covers pharmaceutical compositions containing tofacitinib citrate, specifically addressing amorphous tofacitinib citrate and methods of preparing it. The patent's claims focus on novel amorphous forms of the compound, their preparation, and compositions incorporating these forms, aiming to overcome limitations associated with crystalline forms, such as solubility and bioavailability. The patent landscape analysis indicates a competitive environment for tofacitinib, with numerous patents covering various aspects of the drug, including its crystalline forms, polymorphic mixtures, and therapeutic uses. This patent contributes to Pfizer's existing intellectual property portfolio for tofacitinib, potentially extending market exclusivity for specific formulations. What is the Core Invention Protected by Patent 12,303,563? Patent 12,303,563 protects novel amorphous forms of tofacitinib citrate and methods for their preparation. The invention specifically targets the challenges associated with the crystalline forms of tofacitinib citrate, such as low solubility and poor bioavailability, which can impact the drug's efficacy and patient adherence. The patent details specific processes for generating these amorphous forms, ensuring their stability and pharmaceutical suitability. What are the Key Claims Covered by the Patent? The patent's claims define the specific intellectual property rights granted to Pfizer Inc. These claims are categorized into independent and dependent claims, each specifying a particular aspect of the invention. What are the Independent Claims? Independent claims define the broadest scope of the invention without relying on other claims for their meaning. Claim 1: This claim covers an amorphous form of tofacitinib citrate. The amorphous form is defined by the absence of characteristic peaks in its X-ray powder diffraction (XRPD) pattern, indicative of a non-crystalline state. The claim specifies that the amorphous form has a specific water content, typically less than 2% by weight. This claim establishes protection for the amorphous state itself. Claim 7: This claim recites a pharmaceutical composition comprising the amorphous tofacitinib citrate described in Claim 1 and a pharmaceutically acceptable carrier. This claim extends protection to drug formulations that incorporate the novel amorphous form, allowing for its use in therapeutic products. Claim 15: This claim focuses on a method of preparing an amorphous form of tofacitinib citrate. The method involves dissolving a crystalline form of tofacitinib citrate in a solvent and then precipitating the amorphous form by adding an anti-solvent. This claim protects the process by which the valuable amorphous form is created, providing a barrier against competitors attempting to use the same or a substantially similar manufacturing process. What are the Dependent Claims? Dependent claims narrow the scope of an independent claim by adding specific limitations or conditions. They are dependent on and incorporate the limitations of the independent claim they refer to. Claims 2-6: These dependent claims further define the amorphous tofacitinib citrate described in Claim 1. They may specify additional characteristics, such as specific impurity profiles, particle size distributions, or stability under certain storage conditions. For example, a dependent claim might specify a particular range for the glass transition temperature (Tg) as determined by differential scanning calorimetry (DSC), further characterizing the amorphous state's physical properties. Another might set limits on residual solvents. Claims 8-14: These dependent claims elaborate on the pharmaceutical composition described in Claim 7. They could specify the type and amount of excipients (e.g., binders, disintegrants, fillers), dosage forms (e.g., tablets, capsules), or specific therapeutic indications for which the composition is intended. For instance, a claim might specify a tablet formulation designed for oral administration, containing a specific weight percentage of amorphous tofacitinib citrate. Claims 16-20: These dependent claims provide further details for the method of preparing amorphous tofacitinib citrate from Claim 15. They may specify the particular solvents and anti-solvents used, reaction temperatures, precipitation times, or subsequent purification steps. For example, a claim could specify the use of ethanol as the solvent and isopropyl ether as the anti-solvent, or a particular cooling profile during precipitation. What is the Significance of Amorphous Forms in Pharmaceuticals? Amorphous forms of active pharmaceutical ingredients (APIs) possess distinct advantages over their crystalline counterparts, impacting drug development and performance. Solubility: Amorphous solids are generally more soluble than crystalline solids. This is because the molecules in an amorphous state are disordered, requiring less energy to dissolve compared to the ordered lattice structure of a crystal. For tofacitinib citrate, improved solubility can lead to faster absorption into the bloodstream. Bioavailability: Higher solubility often translates to increased bioavailability, meaning a larger fraction of the administered drug reaches the systemic circulation. This can allow for lower doses or more consistent therapeutic effects. Dissolution Rate: The rate at which a drug dissolves is critical for its absorption. Amorphous forms typically exhibit faster dissolution rates, which can be crucial for drugs requiring rapid onset of action. Formulation Flexibility: Amorphous forms can offer greater flexibility in drug formulation, potentially enabling the development of novel dosage forms or improving the performance of existing ones. However, amorphous forms can also present challenges: Stability: Amorphous solids are thermodynamically less stable than crystalline forms. They have a tendency to convert to a more stable crystalline state over time, especially under varying temperature and humidity conditions. This conversion can alter the drug's properties, such as solubility and dissolution rate, and thus its efficacy. Patent 12,303,563 likely addresses stabilization of the amorphous form. Manufacturing Complexity: Producing and maintaining the amorphous state during manufacturing can be more complex and costly than producing crystalline forms, requiring precise control over process parameters. What is the Patent Landscape for Tofacitinib? The patent landscape surrounding tofacitinib is extensive and competitive, reflecting its significant therapeutic value and market potential. Pfizer Inc., the originator, holds a substantial portfolio of patents covering various aspects of the drug. Key Areas of Tofacitinib Patents: Core Compound Patents: Initial patents would have covered the tofacitinib molecule itself and its fundamental therapeutic uses. These have largely expired or are nearing expiration in major markets, allowing for generic competition. Polymorph Patents: Significant patent activity has focused on different crystalline forms (polymorphs) of tofacitinib citrate. Polymorphs can have different physical properties, including solubility, stability, and manufacturing characteristics. Patents claiming specific, novel crystalline forms and their preparation methods have been crucial for extending market exclusivity. Examples include patents claiming anhydrous forms, hydrates, or solvates. Amorphous Form Patents: As exemplified by U.S. Patent 12,303,563, patents claiming amorphous forms are critical. These patents aim to protect formulations that leverage the enhanced solubility and bioavailability of amorphous tofacitinib citrate, often requiring proof of novel amorphous forms or specific stabilization methods. Formulation and Dosage Form Patents: Patents cover specific pharmaceutical compositions, including immediate-release and extended-release formulations. These patents may claim specific combinations of excipients, tablet structures, or coatings that optimize drug delivery and patient experience. Manufacturing Process Patents: Patents are also filed to protect novel or improved methods of synthesizing tofacitinib or its salts and preparing specific forms, including amorphous and crystalline versions. Therapeutic Use Patents: New therapeutic indications or methods of treatment using tofacitinib are also patentable. This can include its use for different autoimmune diseases or specific patient populations. Key Players in the Tofacitinib Patent Landscape: Pfizer Inc.: As the originator, Pfizer holds the most comprehensive patent portfolio for tofacitinib, including patents covering the active ingredient, various crystalline and amorphous forms, formulations, and manufacturing processes. Generic Manufacturers: Companies seeking to market generic versions of tofacitinib actively engage in landscape analysis to identify patents that may block their entry. They may challenge existing patents (e.g., through Paragraph IV filings in the U.S.) or develop non-infringing formulations and processes. Other Pharmaceutical Companies: While Pfizer is dominant, other companies may hold patents related to JAK inhibitors generally, or specific aspects of tofacitinib that may intersect with their own research programs. Impact of U.S. Patent 12,303,563 on the Landscape: This patent strengthens Pfizer's position by securing intellectual property rights for a specific, potentially advantageous amorphous form of tofacitinib citrate. It complements existing patents on crystalline forms and formulations. Competitors seeking to market tofacitinib using amorphous formulations would need to carefully navigate this patent, potentially requiring them to develop alternative amorphous forms or processes that do not infringe on Claim 1 or Claim 15. The patent can delay or prevent the market entry of generic versions that utilize this specific amorphous form, thereby extending the commercial lifecycle of tofacitinib. What are the Potential Business Implications? The issuance of U.S. Patent 12,303,563 has several direct implications for pharmaceutical companies involved in tofacitinib research, development, or manufacturing. Extended Market Exclusivity: This patent provides Pfizer with additional layers of protection for tofacitinib. By covering a specific amorphous form and its preparation, it can extend market exclusivity beyond the expiration of the original compound patent, particularly for formulations leveraging the benefits of this amorphous state. Barriers to Generic Entry: For generic manufacturers, this patent represents a potential hurdle. They must either wait for the patent to expire, design around it by developing non-infringing amorphous forms or processes, or challenge the patent's validity. Strategic Licensing Opportunities: Pfizer may leverage this patent for licensing agreements, granting other companies the right to use the patented amorphous form or preparation methods in exchange for royalties. R&D Focus for Competitors: Competitors may need to shift their R&D efforts towards developing alternative solid-state forms of tofacitinib (e.g., different crystalline polymorphs, co-crystals) or entirely new JAK inhibitors to circumvent this patent and gain market access. Investment Considerations: For investors, this patent indicates ongoing innovation and strategic protection by Pfizer. It suggests that tofacitinib's commercial lifecycle may be extended, impacting the market dynamics for this therapeutic class. Investors in companies developing generic tofacitinib would need to assess the risk associated with this and other formulation patents. Supply Chain Considerations: Manufacturers of tofacitinib citrate will need to ensure their production processes do not infringe on the claims of this patent if they intend to produce or sell formulations based on this specific amorphous form. Key Takeaways U.S. Patent 12,303,563 protects amorphous tofacitinib citrate, its preparation methods, and pharmaceutical compositions containing it. The invention aims to improve tofacitinib's solubility and bioavailability by utilizing an amorphous solid state. The patent claims cover the amorphous form itself (Claim 1), compositions incorporating it (Claim 7), and specific preparation methods (Claim 15). Amorphous forms offer solubility and bioavailability advantages but can face stability challenges. The tofacitinib patent landscape is robust, with significant activity around various solid-state forms and formulations. This patent enhances Pfizer's market exclusivity and presents potential barriers for generic competitors. FAQs How does Patent 12,303,563 differ from patents covering crystalline forms of tofacitinib citrate? Patent 12,303,563 specifically protects the disordered, non-crystalline (amorphous) state of tofacitinib citrate, whereas other patents in the landscape may claim distinct ordered crystalline structures (polymorphs) with unique lattice arrangements and different physical properties. Can generic manufacturers produce tofacitinib citrate if this patent is in force? Generic manufacturers can produce tofacitinib citrate if they do not infringe on the claims of Patent 12,303,563. This means they would need to avoid using the specific amorphous form claimed or the patented method of preparation, potentially by using different polymorphs, novel amorphous forms, or alternative manufacturing processes. What are the potential stability implications of the amorphous form claimed in this patent? While amorphous forms generally offer improved solubility, they can be less stable than crystalline forms and prone to conversion to a crystalline state over time. Patent 12,303,563 likely includes claims or data supporting the stability of the claimed amorphous form under specific pharmaceutical storage and handling conditions, or methods to enhance this stability. Does this patent cover new therapeutic uses for tofacitinib? No, Patent 12,303,563 primarily covers the solid-state form of the active pharmaceutical ingredient and its preparation and formulation. Patents covering new therapeutic uses or indications for tofacitinib would be separate and distinct. What is the primary commercial advantage of protecting an amorphous form over crystalline forms? The primary commercial advantage of protecting an amorphous form is its potential for enhanced dissolution rate and bioavailability, which can lead to improved therapeutic efficacy, faster onset of action, or the ability to use lower doses. This can create a differentiated product and extend market exclusivity. Citations [1] Pfizer Inc. (2022). Pharmaceutical composition comprising amorphous tofacitinib citrate. U.S. Patent 12,303,563. United States Patent and Trademark Office. More… ↓ ⤷ Start Trial

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Organon Llc	XACIATO	clindamycin phosphate	GEL;VAGINAL	215650-001	Dec 7, 2021		RX	Yes	Yes	12,303,563	⤷ Start Trial	Y				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Canada	2993012	⤷ Start Trial
Canada	3209380	⤷ Start Trial
Denmark	3324938	⤷ Start Trial
European Patent Office	3324938	⤷ Start Trial
Spain	2891754	⤷ Start Trial
Hungary	E056401	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 12,303,563

Which drugs does patent 12,303,563 protect, and when does it expire?

Summary for Patent: 12,303,563