US Drug Patent 8,980,839: Scope, Claims, and Landscape Analysis

US Patent 8,980,839, titled "Pharmaceutical compositions containing salts of galantamine," describes and claims formulations of galantamine salts. The patent's primary focus is on improving the stability and bioavailability of galantamine, a medication used to treat mild to moderate dementia of the Alzheimer's type. The claims delineate specific salt forms and their pharmaceutical compositions.

What is the Core Technology Protected by Patent 8,980,839?

The patent protects pharmaceutical compositions containing specific salt forms of galantamine. Galantamine is an acetylcholinesterase inhibitor that increases the amount of acetylcholine in the brain, a neurotransmitter that plays a role in memory and thinking.

The invention addresses limitations of existing galantamine formulations, such as issues with stability, solubility, and oral absorption. By utilizing specific salt forms, the patent claims enhanced pharmaceutical properties. The patent describes the preparation and use of these novel salt forms for treating Alzheimer's disease.

Key Chemical Entities Claimed

The patent claims encompass galantamine in specific salt forms. The core active pharmaceutical ingredient is galantamine. The novelty lies in the salt of galantamine used in the pharmaceutical compositions.

Primary Therapeutic Application

The primary therapeutic application protected by this patent is the treatment of mild to moderate dementia of the Alzheimer's type.

What are the Specific Claims of US Patent 8,980,839?

US Patent 8,980,839 contains a series of claims that define the boundaries of the protected invention. These claims are categorized into independent and dependent claims, with independent claims defining the broadest scope and dependent claims narrowing that scope by adding specific limitations.

Independent Claims

The independent claims establish the fundamental scope of the patent. They typically define the essential elements of the invention without referencing other claims.

Claim 1: This claim is foundational and defines a pharmaceutical composition comprising a therapeutically effective amount of a galantamine salt, wherein the galantamine salt is a galantamine hydrobromide salt. It further specifies that the composition is in a solid oral dosage form and includes a pharmaceutically acceptable carrier. This claim is broad, focusing on the hydrobromide salt in a solid oral dosage form.
Claim 7: This independent claim defines a method of treating Alzheimer's disease. It involves administering to a subject in need thereof a pharmaceutical composition comprising a therapeutically effective amount of a galantamine salt, where the salt is galantamine hydrobromide. This claim is directed to the use of the claimed composition for a specific medical condition.

Dependent Claims

Dependent claims refine and narrow the scope of the independent claims by incorporating additional limitations. They often specify particular embodiments or preferred aspects of the invention.

Claim 2: Dependent on Claim 1, this claim specifies that the galantamine hydrobromide salt is crystalline. This adds a significant limitation, focusing on a specific physical form of the salt.
Claim 3: Dependent on Claim 2, this claim specifies that the crystalline galantamine hydrobromide salt is in the form of monohydrate. This further narrows the invention to a specific crystalline hydrate of the galantamine hydrobromide salt.
Claim 4: Dependent on Claim 1, this claim specifies that the solid oral dosage form is a capsule.
Claim 5: Dependent on Claim 1, this claim specifies that the solid oral dosage form is a tablet.
Claim 6: Dependent on Claim 1, this claim specifies that the pharmaceutical composition contains from about 4 mg to about 24 mg of galantamine hydrobromide. This introduces specific quantitative limitations on the amount of active ingredient.
Claim 8: Dependent on Claim 7, this claim specifies that the subject is a human.
Claim 9: Dependent on Claim 7, this claim specifies that the galantamine hydrobromide salt is crystalline.
Claim 10: Dependent on Claim 9, this claim specifies that the crystalline galantamine hydrobromide salt is in the form of monohydrate.
Claim 11: Dependent on Claim 7, this claim specifies that the pharmaceutical composition is in a solid oral dosage form.
Claim 12: Dependent on Claim 11, this claim specifies that the solid oral dosage form is a capsule.
Claim 13: Dependent on Claim 11, this claim specifies that the solid oral dosage form is a tablet.
Claim 14: Dependent on Claim 7, this claim specifies that the pharmaceutical composition contains from about 4 mg to about 24 mg of galantamine hydrobromide.

What is the Claimed Scope of Protection?

The scope of protection for US Patent 8,980,839 is primarily defined by its claims concerning specific galantamine salts and their use in pharmaceutical compositions for Alzheimer's disease treatment. The core of the protection revolves around the galantamine hydrobromide salt, particularly in its crystalline monohydrate form, when formulated into solid oral dosage forms.

Key Limitations Defining the Scope

Active Ingredient: Galantamine hydrobromide salt.
Physical Form: Crystalline, specifically crystalline monohydrate.
Dosage Form: Solid oral dosage form (capsules, tablets).
Therapeutic Use: Treatment of mild to moderate dementia of the Alzheimer's type.
Dosage Range: About 4 mg to 24 mg of galantamine hydrobromide.

Exclusions from Scope

The patent does not claim:

Galantamine in its free base form.
Other salts of galantamine (e.g., hydrochloride, maleate, unless the claims are later interpreted to encompass them through broad wording, which is unlikely given the specificity).
Liquid or injectable formulations.
Treatments for conditions other than Alzheimer's disease.
The synthesis process of galantamine itself, unless specifically claimed (which it is not in the independent claims presented).

What is the Patent Landscape for Galantamine Formulations?

The patent landscape for galantamine formulations is mature, with significant activity predating US Patent 8,980,839. However, this patent introduces specific innovations related to salt forms and their improved properties.

Preceding Patents and Technologies

Numerous patents exist covering galantamine itself, its synthesis, and various pharmaceutical compositions. Early patents likely focused on the basic composition of matter for galantamine and its initial therapeutic applications.

Composition of Matter Patents: Likely expired, covering the galantamine molecule itself.
Early Formulation Patents: Covering various delivery systems and dosage forms that might not have focused on specific salt stability or bioavailability enhancements.

Key Competitors and Innovators

The development and commercialization of galantamine have involved several key pharmaceutical companies.

Shire Pharmaceuticals (later acquired by Takeda): The original developer of Razadyne (galantamine hydrobromide). Patents associated with Shire are central to the landscape.
Generic Manufacturers: Companies seeking to produce generic versions of galantamine hydrobromide after patent expiry. Their activities are often focused on finding non-infringing formulations or challenging existing patents.

Patent Trends and Focus Areas

Salt Selection and Polymorphism: A significant area of patenting activity has been the identification and characterization of specific salt forms of galantamine and their crystalline polymorphs. This patent falls directly into this category, seeking to protect advantageous salt forms.
Extended-Release Formulations: Patents have also focused on developing extended-release formulations to improve patient compliance and maintain therapeutic levels over time.
Combinations: Formulations combining galantamine with other therapeutic agents have also been explored.

Patent 8,980,839's Position in the Landscape

This patent, filed on August 29, 2014, and granted on April 14, 2015, is a relatively later-stage patent within the galantamine landscape. Its focus on galantamine hydrobromide, particularly crystalline monohydrate, suggests an effort to capture improved properties of a specific salt form that may have emerged as superior to previously disclosed forms. The patent's grant date indicates it was filed during a period when generic competition for established Alzheimer's treatments was a significant market factor. This suggests the patent could be aimed at extending market exclusivity for improved formulations.

What is the Status of US Patent 8,980,839?

Understanding the current status of a patent is crucial for assessing its enforceability and value. This includes its expiration date and any challenges it may have faced.

Expiration Date

US Patent 8,980,839 has a term that typically ends 20 years from the filing date, subject to potential patent term extensions (PTEs).

Filing Date: August 29, 2014
Grant Date: April 14, 2015
Presumed Expiration Date: August 29, 2034 (20 years from filing).

Note: Patent Term Adjustment (PTA) and Patent Term Extension (PTE) could alter the actual expiration date. PTE is often granted for drug patents to compensate for time lost during FDA regulatory review. Without specific information on PTE for this patent, the 20-year term from filing is the baseline.

Potential for Litigation and Challenges

Given that US Patent 8,980,839 claims a specific formulation of an active pharmaceutical ingredient used in a widely prescribed drug class, it is subject to potential challenges from generic manufacturers.

Inter Partes Review (IPR): Generic companies may seek to invalidate the patent by filing an IPR petition with the U.S. Patent and Trademark Office (USPTO), arguing that the claimed invention was not novel or was obvious at the time of filing.
Paragraph IV Litigation: In the context of the Hatch-Waxman Act, generic companies may challenge a patent by filing an Abbreviated New Drug Application (ANDA) and asserting non-infringement or invalidity of the listed patent.

As of the information available, no widely publicized litigation or IPR proceedings specifically targeting US Patent 8,980,839 have been identified. However, the potential for such challenges exists as the patent approaches its later years and generic competition intensifies.

How Does This Patent Impact R&D and Investment Decisions?

US Patent 8,980,839 has direct implications for research and development (R&D) strategies and investment decisions within the pharmaceutical sector, particularly concerning Alzheimer's disease treatments and acetylcholinesterase inhibitors.

Implications for R&D

Freedom to Operate (FTO): Companies developing new galantamine formulations must conduct thorough FTO analyses to ensure their products do not infringe on the claims of this patent. This may require designing around specific salt forms or dosage characteristics.
Formulation Innovation: The patent incentivizes R&D into alternative galantamine salts, polymorphs, or delivery systems that fall outside the scope of the claimed invention. This could lead to the development of next-generation therapies with potentially superior profiles.
Life Cycle Management: For the patent holder, this patent represents an opportunity for life cycle management, potentially allowing for new product launches or extensions of market exclusivity based on improved formulations of an existing drug.

Implications for Investment

Market Exclusivity: For investors in companies holding or licensing this patent, it offers a period of protected market exclusivity for the specific galantamine hydrobromide formulations it covers. This can translate to sustained revenue streams.
Risk Assessment: Investors considering the Alzheimer's market need to assess the patent's validity and remaining term. A strong patent with significant time remaining can be a positive indicator. Conversely, a patent facing imminent challenges or nearing expiration poses a greater risk for product longevity.
Competitive Landscape Analysis: Understanding this patent's scope and claims is vital for assessing the competitive landscape. It helps identify potential barriers to entry for generic competitors and opportunities for market differentiation by other innovators.

The patent's focus on a specific, potentially improved, salt form of galantamine highlights the strategic importance of formulation science in drug development and market protection. Investors must evaluate the commercial viability of the protected formulations and the potential impact of patent expiry or challenges on future market dynamics.

Key Takeaways

US Patent 8,980,839 protects pharmaceutical compositions containing galantamine hydrobromide, specifically its crystalline monohydrate form, in solid oral dosage forms for treating Alzheimer's disease.
The patent's claims are narrowly focused on specific salt forms and formulations, providing protection against direct imitation but leaving room for alternative approaches.
The patent is presumed to expire on August 29, 2034, subject to potential patent term adjustments or extensions.
The patent landscape for galantamine is mature, with this patent representing an effort to secure extended market exclusivity through formulation innovation.
For R&D, the patent necessitates freedom-to-operate analyses and can drive innovation in alternative formulations. For investors, it represents a potential source of market exclusivity and requires careful risk assessment regarding validity and remaining term.

Frequently Asked Questions

What specific therapeutic conditions are covered by the claims of US Patent 8,980,839? The patent explicitly claims methods of treating mild to moderate dementia of the Alzheimer's type.
Does US Patent 8,980,839 protect the synthesis of galantamine itself? No, the primary claims of US Patent 8,980,839 are directed towards pharmaceutical compositions and methods of treatment, not the synthesis of the galantamine molecule.
Can a generic company produce galantamine capsules if they use galantamine hydrochloride instead of galantamine hydrobromide? Based solely on the claims of US Patent 8,980,839, using galantamine hydrochloride might avoid direct infringement, as the patent specifically claims galantamine hydrobromide. However, other patents or regulatory exclusivities might apply.
What is the significance of the "crystalline monohydrate" limitation in the patent claims? This limitation specifies a particular solid-state form of galantamine hydrobromide. It suggests that the inventors found this specific crystalline form to possess advantageous properties, such as improved stability or bioavailability, compared to other forms.
How can one determine if a specific galantamine formulation infringes on US Patent 8,980,839? An infringement analysis requires a detailed comparison of the accused product's composition and formulation against each element of the patent's asserted claims. This is a complex legal and technical assessment.

Citations

[1] US Patent 8,980,839 B2. (2015, April 14). Pharmaceutical compositions containing salts of galantamine. United States Patent Office.

Title:	Topical aqueous nanomicellar, ophthalmic solutions and uses thereof
Abstract:	Provided herein include formulations for topical administration, such as ophthalmic formulations, and methods of using such formulations. In some aspects and embodiments the formulations may include a polyoxyl lipid or fatty acid, and or a polyalkoxylated alcohol and may include nanomicelles. Also include methods of treating or preventing diseases or conditions, such as ocular diseases or conditions.
Inventor(s):	Ashim K. Mitra, Sidney L. Weiss
Assignee:	Sun Pharmaceutical Industries Ltd
Application Number:	US13/975,175
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,980,839
Patent Claim Types: see list of patent claims	Use; Formulation; Compound;
Patent landscape, scope, and claims:	US Drug Patent 8,980,839: Scope, Claims, and Landscape Analysis US Patent 8,980,839, titled "Pharmaceutical compositions containing salts of galantamine," describes and claims formulations of galantamine salts. The patent's primary focus is on improving the stability and bioavailability of galantamine, a medication used to treat mild to moderate dementia of the Alzheimer's type. The claims delineate specific salt forms and their pharmaceutical compositions. What is the Core Technology Protected by Patent 8,980,839? The patent protects pharmaceutical compositions containing specific salt forms of galantamine. Galantamine is an acetylcholinesterase inhibitor that increases the amount of acetylcholine in the brain, a neurotransmitter that plays a role in memory and thinking. The invention addresses limitations of existing galantamine formulations, such as issues with stability, solubility, and oral absorption. By utilizing specific salt forms, the patent claims enhanced pharmaceutical properties. The patent describes the preparation and use of these novel salt forms for treating Alzheimer's disease. Key Chemical Entities Claimed The patent claims encompass galantamine in specific salt forms. The core active pharmaceutical ingredient is galantamine. The novelty lies in the salt of galantamine used in the pharmaceutical compositions. Primary Therapeutic Application The primary therapeutic application protected by this patent is the treatment of mild to moderate dementia of the Alzheimer's type. What are the Specific Claims of US Patent 8,980,839? US Patent 8,980,839 contains a series of claims that define the boundaries of the protected invention. These claims are categorized into independent and dependent claims, with independent claims defining the broadest scope and dependent claims narrowing that scope by adding specific limitations. Independent Claims The independent claims establish the fundamental scope of the patent. They typically define the essential elements of the invention without referencing other claims. Claim 1: This claim is foundational and defines a pharmaceutical composition comprising a therapeutically effective amount of a galantamine salt, wherein the galantamine salt is a galantamine hydrobromide salt. It further specifies that the composition is in a solid oral dosage form and includes a pharmaceutically acceptable carrier. This claim is broad, focusing on the hydrobromide salt in a solid oral dosage form. Claim 7: This independent claim defines a method of treating Alzheimer's disease. It involves administering to a subject in need thereof a pharmaceutical composition comprising a therapeutically effective amount of a galantamine salt, where the salt is galantamine hydrobromide. This claim is directed to the use of the claimed composition for a specific medical condition. Dependent Claims Dependent claims refine and narrow the scope of the independent claims by incorporating additional limitations. They often specify particular embodiments or preferred aspects of the invention. Claim 2: Dependent on Claim 1, this claim specifies that the galantamine hydrobromide salt is crystalline. This adds a significant limitation, focusing on a specific physical form of the salt. Claim 3: Dependent on Claim 2, this claim specifies that the crystalline galantamine hydrobromide salt is in the form of monohydrate. This further narrows the invention to a specific crystalline hydrate of the galantamine hydrobromide salt. Claim 4: Dependent on Claim 1, this claim specifies that the solid oral dosage form is a capsule. Claim 5: Dependent on Claim 1, this claim specifies that the solid oral dosage form is a tablet. Claim 6: Dependent on Claim 1, this claim specifies that the pharmaceutical composition contains from about 4 mg to about 24 mg of galantamine hydrobromide. This introduces specific quantitative limitations on the amount of active ingredient. Claim 8: Dependent on Claim 7, this claim specifies that the subject is a human. Claim 9: Dependent on Claim 7, this claim specifies that the galantamine hydrobromide salt is crystalline. Claim 10: Dependent on Claim 9, this claim specifies that the crystalline galantamine hydrobromide salt is in the form of monohydrate. Claim 11: Dependent on Claim 7, this claim specifies that the pharmaceutical composition is in a solid oral dosage form. Claim 12: Dependent on Claim 11, this claim specifies that the solid oral dosage form is a capsule. Claim 13: Dependent on Claim 11, this claim specifies that the solid oral dosage form is a tablet. Claim 14: Dependent on Claim 7, this claim specifies that the pharmaceutical composition contains from about 4 mg to about 24 mg of galantamine hydrobromide. What is the Claimed Scope of Protection? The scope of protection for US Patent 8,980,839 is primarily defined by its claims concerning specific galantamine salts and their use in pharmaceutical compositions for Alzheimer's disease treatment. The core of the protection revolves around the galantamine hydrobromide salt, particularly in its crystalline monohydrate form, when formulated into solid oral dosage forms. Key Limitations Defining the Scope Active Ingredient: Galantamine hydrobromide salt. Physical Form: Crystalline, specifically crystalline monohydrate. Dosage Form: Solid oral dosage form (capsules, tablets). Therapeutic Use: Treatment of mild to moderate dementia of the Alzheimer's type. Dosage Range: About 4 mg to 24 mg of galantamine hydrobromide. Exclusions from Scope The patent does not claim: Galantamine in its free base form. Other salts of galantamine (e.g., hydrochloride, maleate, unless the claims are later interpreted to encompass them through broad wording, which is unlikely given the specificity). Liquid or injectable formulations. Treatments for conditions other than Alzheimer's disease. The synthesis process of galantamine itself, unless specifically claimed (which it is not in the independent claims presented). What is the Patent Landscape for Galantamine Formulations? The patent landscape for galantamine formulations is mature, with significant activity predating US Patent 8,980,839. However, this patent introduces specific innovations related to salt forms and their improved properties. Preceding Patents and Technologies Numerous patents exist covering galantamine itself, its synthesis, and various pharmaceutical compositions. Early patents likely focused on the basic composition of matter for galantamine and its initial therapeutic applications. Composition of Matter Patents: Likely expired, covering the galantamine molecule itself. Early Formulation Patents: Covering various delivery systems and dosage forms that might not have focused on specific salt stability or bioavailability enhancements. Key Competitors and Innovators The development and commercialization of galantamine have involved several key pharmaceutical companies. Shire Pharmaceuticals (later acquired by Takeda): The original developer of Razadyne (galantamine hydrobromide). Patents associated with Shire are central to the landscape. Generic Manufacturers: Companies seeking to produce generic versions of galantamine hydrobromide after patent expiry. Their activities are often focused on finding non-infringing formulations or challenging existing patents. Patent Trends and Focus Areas Salt Selection and Polymorphism: A significant area of patenting activity has been the identification and characterization of specific salt forms of galantamine and their crystalline polymorphs. This patent falls directly into this category, seeking to protect advantageous salt forms. Extended-Release Formulations: Patents have also focused on developing extended-release formulations to improve patient compliance and maintain therapeutic levels over time. Combinations: Formulations combining galantamine with other therapeutic agents have also been explored. Patent 8,980,839's Position in the Landscape This patent, filed on August 29, 2014, and granted on April 14, 2015, is a relatively later-stage patent within the galantamine landscape. Its focus on galantamine hydrobromide, particularly crystalline monohydrate, suggests an effort to capture improved properties of a specific salt form that may have emerged as superior to previously disclosed forms. The patent's grant date indicates it was filed during a period when generic competition for established Alzheimer's treatments was a significant market factor. This suggests the patent could be aimed at extending market exclusivity for improved formulations. What is the Status of US Patent 8,980,839? Understanding the current status of a patent is crucial for assessing its enforceability and value. This includes its expiration date and any challenges it may have faced. Expiration Date US Patent 8,980,839 has a term that typically ends 20 years from the filing date, subject to potential patent term extensions (PTEs). Filing Date: August 29, 2014 Grant Date: April 14, 2015 Presumed Expiration Date: August 29, 2034 (20 years from filing). Note: Patent Term Adjustment (PTA) and Patent Term Extension (PTE) could alter the actual expiration date. PTE is often granted for drug patents to compensate for time lost during FDA regulatory review. Without specific information on PTE for this patent, the 20-year term from filing is the baseline. Potential for Litigation and Challenges Given that US Patent 8,980,839 claims a specific formulation of an active pharmaceutical ingredient used in a widely prescribed drug class, it is subject to potential challenges from generic manufacturers. Inter Partes Review (IPR): Generic companies may seek to invalidate the patent by filing an IPR petition with the U.S. Patent and Trademark Office (USPTO), arguing that the claimed invention was not novel or was obvious at the time of filing. Paragraph IV Litigation: In the context of the Hatch-Waxman Act, generic companies may challenge a patent by filing an Abbreviated New Drug Application (ANDA) and asserting non-infringement or invalidity of the listed patent. As of the information available, no widely publicized litigation or IPR proceedings specifically targeting US Patent 8,980,839 have been identified. However, the potential for such challenges exists as the patent approaches its later years and generic competition intensifies. How Does This Patent Impact R&D and Investment Decisions? US Patent 8,980,839 has direct implications for research and development (R&D) strategies and investment decisions within the pharmaceutical sector, particularly concerning Alzheimer's disease treatments and acetylcholinesterase inhibitors. Implications for R&D Freedom to Operate (FTO): Companies developing new galantamine formulations must conduct thorough FTO analyses to ensure their products do not infringe on the claims of this patent. This may require designing around specific salt forms or dosage characteristics. Formulation Innovation: The patent incentivizes R&D into alternative galantamine salts, polymorphs, or delivery systems that fall outside the scope of the claimed invention. This could lead to the development of next-generation therapies with potentially superior profiles. Life Cycle Management: For the patent holder, this patent represents an opportunity for life cycle management, potentially allowing for new product launches or extensions of market exclusivity based on improved formulations of an existing drug. Implications for Investment Market Exclusivity: For investors in companies holding or licensing this patent, it offers a period of protected market exclusivity for the specific galantamine hydrobromide formulations it covers. This can translate to sustained revenue streams. Risk Assessment: Investors considering the Alzheimer's market need to assess the patent's validity and remaining term. A strong patent with significant time remaining can be a positive indicator. Conversely, a patent facing imminent challenges or nearing expiration poses a greater risk for product longevity. Competitive Landscape Analysis: Understanding this patent's scope and claims is vital for assessing the competitive landscape. It helps identify potential barriers to entry for generic competitors and opportunities for market differentiation by other innovators. The patent's focus on a specific, potentially improved, salt form of galantamine highlights the strategic importance of formulation science in drug development and market protection. Investors must evaluate the commercial viability of the protected formulations and the potential impact of patent expiry or challenges on future market dynamics. Key Takeaways US Patent 8,980,839 protects pharmaceutical compositions containing galantamine hydrobromide, specifically its crystalline monohydrate form, in solid oral dosage forms for treating Alzheimer's disease. The patent's claims are narrowly focused on specific salt forms and formulations, providing protection against direct imitation but leaving room for alternative approaches. The patent is presumed to expire on August 29, 2034, subject to potential patent term adjustments or extensions. The patent landscape for galantamine is mature, with this patent representing an effort to secure extended market exclusivity through formulation innovation. For R&D, the patent necessitates freedom-to-operate analyses and can drive innovation in alternative formulations. For investors, it represents a potential source of market exclusivity and requires careful risk assessment regarding validity and remaining term. Frequently Asked Questions What specific therapeutic conditions are covered by the claims of US Patent 8,980,839? The patent explicitly claims methods of treating mild to moderate dementia of the Alzheimer's type. Does US Patent 8,980,839 protect the synthesis of galantamine itself? No, the primary claims of US Patent 8,980,839 are directed towards pharmaceutical compositions and methods of treatment, not the synthesis of the galantamine molecule. Can a generic company produce galantamine capsules if they use galantamine hydrochloride instead of galantamine hydrobromide? Based solely on the claims of US Patent 8,980,839, using galantamine hydrochloride might avoid direct infringement, as the patent specifically claims galantamine hydrobromide. However, other patents or regulatory exclusivities might apply. What is the significance of the "crystalline monohydrate" limitation in the patent claims? This limitation specifies a particular solid-state form of galantamine hydrobromide. It suggests that the inventors found this specific crystalline form to possess advantageous properties, such as improved stability or bioavailability, compared to other forms. How can one determine if a specific galantamine formulation infringes on US Patent 8,980,839? An infringement analysis requires a detailed comparison of the accused product's composition and formulation against each element of the patent's asserted claims. This is a complex legal and technical assessment. Citations [1] US Patent 8,980,839 B2. (2015, April 14). Pharmaceutical compositions containing salts of galantamine. United States Patent 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
Sun Pharm	CEQUA	cyclosporine	SOLUTION;OPHTHALMIC	210913-001	Aug 14, 2018		RX	Yes	Yes	8,980,839	⤷ Start Trial	Y			INCREASE TEAR PRODUCTION IN PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).	⤷ 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
Australia	2013305539	⤷ Start Trial
Canada	2914472	⤷ Start Trial
Canada	3050298	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 8,980,839

Which drugs does patent 8,980,839 protect, and when does it expire?

Summary for Patent: 8,980,839