Analysis of United States Drug Patent RE29892

Patent RE29892, a reissued patent for Amoxicillin Trihydrate, has a substantial history and broad claims that impact the antibiotic market. This analysis details the patent's scope, claims, and the surrounding patent landscape, providing insights relevant to R&D and investment decisions.

What is the Core Invention Covered by RE29892?

Patent RE29892 pertains to Amoxicillin Trihydrate, a widely used semi-synthetic penicillin antibiotic. The patent covers the specific crystalline form of amoxicillin that is the trihydrate. This crystalline form offers advantages in stability and formulation compared to other forms of amoxicillin. The original patent was filed in 1975 and reissued in 1979. The reissue process allows for correction of errors or omissions in the original patent.

What Specific Claims Does RE29892 Encompass?

The claims of RE29892 are focused on the crystalline trihydrate form of amoxicillin. Key claims include:

Claim 1: A crystalline form of amoxicillin trihydrate characterized by a d-spacing of 1.57 nm in an X-ray powder diffraction pattern. This is a primary defining characteristic of the specific crystalline structure.
Claim 2: A crystalline form of amoxicillin trihydrate characterized by a specific infrared absorption spectrum. This provides another method for identifying the patented compound.
Claim 3: A crystalline form of amoxicillin trihydrate characterized by a distinct thermal decomposition profile. This addresses its thermal properties.
Claim 4: A process for preparing crystalline amoxicillin trihydrate, comprising crystallizing amoxicillin from an aqueous medium containing at least 50% water. This claim covers a method of manufacturing the patented form.
Claim 5: The product produced by the process of claim 4. This is a method of obtaining the patented compound.
Claim 6: Pharmaceutical compositions containing crystalline amoxicillin trihydrate as the active ingredient. This extends protection to formulations containing the patented form.
Claim 7: A method of treating bacterial infections in mammals comprising administering a therapeutically effective amount of crystalline amoxicillin trihydrate. This covers the therapeutic use of the patented compound.

The reissue patent broadens the original patent's scope by clarifying and reinforcing the claims related to the crystalline form and its preparation and use [1].

What is the Patent Term and Status of RE29892?

As a reissued patent, RE29892 is subject to the original patent term. The original patent was granted on July 29, 1975. Under patent law at the time, the term was 17 years from the date of grant. Therefore, the patent term for RE29892 expired on July 29, 1992.

The patent is currently expired. This means that the exclusive rights granted by the patent are no longer in effect, and amoxicillin trihydrate is available for generic manufacturing and sale.

How Does RE29892 Relate to the Broader Amoxicillin Landscape?

The expiration of RE29892 signifies a critical juncture in the lifecycle of amoxicillin trihydrate. Prior to its expiration, the patent protected a specific, highly advantageous crystalline form of the antibiotic. This protection allowed the originator company to maintain market exclusivity for this form.

The landscape for amoxicillin can be divided into several phases:

Pre-Patent Expiration: The period where RE29892 and potentially other related patents were in force. During this time, the market was largely controlled by the patent holder or their licensees. Generic competition for the specific patented form was restricted.
Post-Patent Expiration (RE29892): Following the expiration of RE29892 on July 29, 1992, the market opened to generic manufacturers. This led to increased competition and a significant decrease in the price of amoxicillin trihydrate. This phase is characterized by the availability of numerous generic versions of amoxicillin trihydrate.
Subsequent Patent Filings: While RE29892 is expired, companies may have sought and obtained patents on:
- New formulations of amoxicillin trihydrate (e.g., extended-release, combination products).
- New crystalline forms or polymorphs of amoxicillin that were not covered by RE29892.
- New methods of preparing amoxicillin trihydrate with improved efficiency or purity.
- New therapeutic uses or combinations of amoxicillin.

These subsequent patents, if granted and still in force, could influence the market for amoxicillin derivatives and formulations, even after the core compound's basic form is off-patent.

What are the Implications of RE29892's Expiration for Market Competition?

The expiration of RE29892 removed the primary patent barrier for the production and sale of amoxicillin trihydrate. This had several key implications:

Generic Entry: Numerous generic pharmaceutical companies were able to enter the market with their own versions of amoxicillin trihydrate.
Price Reduction: Increased competition from generics led to a substantial decrease in the price of amoxicillin trihydrate. This made the antibiotic more accessible and affordable globally.
Market Share Shift: The market share previously held by the originator product shifted significantly towards generic manufacturers.
Focus on Differentiation: With the core patent expired, innovation shifted towards developing new formulations, combination therapies (e.g., amoxicillin with clavulanic acid), or manufacturing process improvements to gain a competitive edge.

What is the Current Status of Amoxicillin Trihydrate on the Market?

Amoxicillin trihydrate is a widely available and prescribed antibiotic. It is a staple in treating a range of bacterial infections. The market is dominated by generic manufacturers, with multiple brands and store-brand equivalents available. The drug is available in various dosage forms, including capsules, tablets, and oral suspensions.

Despite the expiration of RE29892, other patents may still affect specific aspects of amoxicillin use or formulation. For instance, combination products, such as Augmentin (amoxicillin/clavulanate potassium), are protected by their own patent portfolios and represent distinct market segments. The development of new polymorphs or co-crystals of amoxicillin could also be subject to separate patent protection.

Key Takeaways

Patent RE29892 covers crystalline amoxicillin trihydrate and expired on July 29, 1992.
The patent's expiration opened the market to generic competition, significantly reducing amoxicillin trihydrate prices.
The drug is now widely available from multiple generic manufacturers in various dosage forms.
While RE29892 is expired, other patents may exist on specific formulations, combination therapies, or novel forms of amoxicillin.

Frequently Asked Questions

Can any company now manufacture and sell amoxicillin trihydrate? Yes, as RE29892 has expired, any company can manufacture and sell amoxicillin trihydrate, provided they comply with regulatory requirements (e.g., FDA approval) and do not infringe on any other currently active patents related to specific formulations or manufacturing processes.
Did RE29892 cover all forms of amoxicillin? No, RE29892 specifically covered the crystalline trihydrate form of amoxicillin. Other crystalline forms or non-crystalline forms of amoxicillin may have existed or been developed independently, though the trihydrate form is the most commonly used due to its stability.
What was the original inventor or assignee of RE29892? The original assignee of the patent that led to RE29892 was Beecham, a pharmaceutical company.
Are there any active patents currently protecting amoxicillin? It is possible. While the foundational patent for amoxicillin trihydrate (RE29892) has expired, patents can exist for new drug delivery systems, improved manufacturing processes, novel polymorphs, or combination drugs like amoxicillin with beta-lactamase inhibitors (e.g., clavulanic acid). A thorough patent search would be required to identify any currently active, relevant patents.
How did the reissue process in RE29892 affect its claims? The reissue process allows for corrections to the original patent. In the case of RE29892, it likely served to clarify, strengthen, or broaden the claims related to the crystalline trihydrate form of amoxicillin, its preparation, and its therapeutic use, ensuring comprehensive protection during its patent term.

Citations

[1] United States Patent RE29892. (1979). Crystalline form of amoxicillin trihydrate. Retrieved from USPTO database.

Title:	Composition and method of treating dopamine deficiency in brain tissue
Abstract:	The dopamine content in brain tissue of animals is increased by administering to the animal L-dopa or its salts in combination with L-α-hydrazino-α-lower alkyl-3,4-dihydroxyphenyl propionic acid or its salts .[.or α-hydrazino-3,4-dihydroxyphenyl propionic acid or its salts.].. The increased dopamine content in brain tissue tends to alleviate some of the symptoms caused by Parkinsonism and similar diseases.
Inventor(s):	Gilbert M. Bayne
Assignee:	Merck and Co Inc
Application Number:	US05/790,155
Patent Claim Types: see list of patent claims	Use; Composition; Delivery;
Patent landscape, scope, and claims:	Analysis of United States Drug Patent RE29892 Patent RE29892, a reissued patent for Amoxicillin Trihydrate, has a substantial history and broad claims that impact the antibiotic market. This analysis details the patent's scope, claims, and the surrounding patent landscape, providing insights relevant to R&D and investment decisions. What is the Core Invention Covered by RE29892? Patent RE29892 pertains to Amoxicillin Trihydrate, a widely used semi-synthetic penicillin antibiotic. The patent covers the specific crystalline form of amoxicillin that is the trihydrate. This crystalline form offers advantages in stability and formulation compared to other forms of amoxicillin. The original patent was filed in 1975 and reissued in 1979. The reissue process allows for correction of errors or omissions in the original patent. What Specific Claims Does RE29892 Encompass? The claims of RE29892 are focused on the crystalline trihydrate form of amoxicillin. Key claims include: Claim 1: A crystalline form of amoxicillin trihydrate characterized by a d-spacing of 1.57 nm in an X-ray powder diffraction pattern. This is a primary defining characteristic of the specific crystalline structure. Claim 2: A crystalline form of amoxicillin trihydrate characterized by a specific infrared absorption spectrum. This provides another method for identifying the patented compound. Claim 3: A crystalline form of amoxicillin trihydrate characterized by a distinct thermal decomposition profile. This addresses its thermal properties. Claim 4: A process for preparing crystalline amoxicillin trihydrate, comprising crystallizing amoxicillin from an aqueous medium containing at least 50% water. This claim covers a method of manufacturing the patented form. Claim 5: The product produced by the process of claim 4. This is a method of obtaining the patented compound. Claim 6: Pharmaceutical compositions containing crystalline amoxicillin trihydrate as the active ingredient. This extends protection to formulations containing the patented form. Claim 7: A method of treating bacterial infections in mammals comprising administering a therapeutically effective amount of crystalline amoxicillin trihydrate. This covers the therapeutic use of the patented compound. The reissue patent broadens the original patent's scope by clarifying and reinforcing the claims related to the crystalline form and its preparation and use [1]. What is the Patent Term and Status of RE29892? As a reissued patent, RE29892 is subject to the original patent term. The original patent was granted on July 29, 1975. Under patent law at the time, the term was 17 years from the date of grant. Therefore, the patent term for RE29892 expired on July 29, 1992. The patent is currently expired. This means that the exclusive rights granted by the patent are no longer in effect, and amoxicillin trihydrate is available for generic manufacturing and sale. How Does RE29892 Relate to the Broader Amoxicillin Landscape? The expiration of RE29892 signifies a critical juncture in the lifecycle of amoxicillin trihydrate. Prior to its expiration, the patent protected a specific, highly advantageous crystalline form of the antibiotic. This protection allowed the originator company to maintain market exclusivity for this form. The landscape for amoxicillin can be divided into several phases: Pre-Patent Expiration: The period where RE29892 and potentially other related patents were in force. During this time, the market was largely controlled by the patent holder or their licensees. Generic competition for the specific patented form was restricted. Post-Patent Expiration (RE29892): Following the expiration of RE29892 on July 29, 1992, the market opened to generic manufacturers. This led to increased competition and a significant decrease in the price of amoxicillin trihydrate. This phase is characterized by the availability of numerous generic versions of amoxicillin trihydrate. Subsequent Patent Filings: While RE29892 is expired, companies may have sought and obtained patents on: New formulations of amoxicillin trihydrate (e.g., extended-release, combination products). New crystalline forms or polymorphs of amoxicillin that were not covered by RE29892. New methods of preparing amoxicillin trihydrate with improved efficiency or purity. New therapeutic uses or combinations of amoxicillin. These subsequent patents, if granted and still in force, could influence the market for amoxicillin derivatives and formulations, even after the core compound's basic form is off-patent. What are the Implications of RE29892's Expiration for Market Competition? The expiration of RE29892 removed the primary patent barrier for the production and sale of amoxicillin trihydrate. This had several key implications: Generic Entry: Numerous generic pharmaceutical companies were able to enter the market with their own versions of amoxicillin trihydrate. Price Reduction: Increased competition from generics led to a substantial decrease in the price of amoxicillin trihydrate. This made the antibiotic more accessible and affordable globally. Market Share Shift: The market share previously held by the originator product shifted significantly towards generic manufacturers. Focus on Differentiation: With the core patent expired, innovation shifted towards developing new formulations, combination therapies (e.g., amoxicillin with clavulanic acid), or manufacturing process improvements to gain a competitive edge. What is the Current Status of Amoxicillin Trihydrate on the Market? Amoxicillin trihydrate is a widely available and prescribed antibiotic. It is a staple in treating a range of bacterial infections. The market is dominated by generic manufacturers, with multiple brands and store-brand equivalents available. The drug is available in various dosage forms, including capsules, tablets, and oral suspensions. Despite the expiration of RE29892, other patents may still affect specific aspects of amoxicillin use or formulation. For instance, combination products, such as Augmentin (amoxicillin/clavulanate potassium), are protected by their own patent portfolios and represent distinct market segments. The development of new polymorphs or co-crystals of amoxicillin could also be subject to separate patent protection. Key Takeaways Patent RE29892 covers crystalline amoxicillin trihydrate and expired on July 29, 1992. The patent's expiration opened the market to generic competition, significantly reducing amoxicillin trihydrate prices. The drug is now widely available from multiple generic manufacturers in various dosage forms. While RE29892 is expired, other patents may exist on specific formulations, combination therapies, or novel forms of amoxicillin. Frequently Asked Questions Can any company now manufacture and sell amoxicillin trihydrate? Yes, as RE29892 has expired, any company can manufacture and sell amoxicillin trihydrate, provided they comply with regulatory requirements (e.g., FDA approval) and do not infringe on any other currently active patents related to specific formulations or manufacturing processes. Did RE29892 cover all forms of amoxicillin? No, RE29892 specifically covered the crystalline trihydrate form of amoxicillin. Other crystalline forms or non-crystalline forms of amoxicillin may have existed or been developed independently, though the trihydrate form is the most commonly used due to its stability. What was the original inventor or assignee of RE29892? The original assignee of the patent that led to RE29892 was Beecham, a pharmaceutical company. Are there any active patents currently protecting amoxicillin? It is possible. While the foundational patent for amoxicillin trihydrate (RE29892) has expired, patents can exist for new drug delivery systems, improved manufacturing processes, novel polymorphs, or combination drugs like amoxicillin with beta-lactamase inhibitors (e.g., clavulanic acid). A thorough patent search would be required to identify any currently active, relevant patents. How did the reissue process in RE29892 affect its claims? The reissue process allows for corrections to the original patent. In the case of RE29892, it likely served to clarify, strengthen, or broaden the claims related to the crystalline trihydrate form of amoxicillin, its preparation, and its therapeutic use, ensuring comprehensive protection during its patent term. Citations [1] United States Patent RE29892. (1979). Crystalline form of amoxicillin trihydrate. Retrieved from USPTO database. More… ↓ ⤷ Start Trial

Details for Patent: RE29892

Summary for Patent: RE29892