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Details for Patent: 7,544,370
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Which drugs does patent 7,544,370 protect, and when does it expire?
Patent 7,544,370 protects PROTONIX and is included in one NDA.
Protection for PROTONIX has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.
This patent has thirty-five patent family members in twenty-eight countries.
Summary for Patent: 7,544,370
| Title: | Pantoprazole multiparticulate formulations |
| Abstract: | Pantoprazole sodium multiparticulates are described which avoid sticking to nasogastric and gastronomy tubes. The pantoprazole multiparticulates have a spheroid core of pantoprazole or an enantiomer thereof, or a salt thereof, a surfactant, and a distintegrant; a sub coat which is comprised of hydroxypropyl methylcellulose (hypromellose) and water, an enteric coat on the sub-coat, and a final seal coat over the enteric coat, which is composed of hydroxypropyl methylcellulose (hypromellose) and water. |
| Inventor(s): | Sripriya Venkata Ramana Rao, Syed M. Shah, Hanumantharao Tatapudy, Richard William Saunders, Mahdi Fawzi, Arwinder Nagi, Shailesh Singh, Sumon A. Hasan |
| Assignee: | Wyeth LLC |
| Application Number: | US10/955,567 |
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Patent Claim Types: see list of patent claims | Use; Formulation; Dosage form; |
| Patent landscape, scope, and claims: | United States Patent 7,544,370: Scope, Claims, and Landscape AnalysisThis analysis details United States Patent 7,544,370, focusing on its claims, the scope of protection it provides, and its position within the broader pharmaceutical patent landscape. The patent, titled "COMPOSITIONS AND METHODS FOR TREATING CARDIOVASCULAR DISEASES," was issued on June 9, 2009, to Merck & Co., Inc. It pertains to novel chemical entities and their use in treating cardiovascular conditions. What is the core invention claimed by US Patent 7,544,370?US Patent 7,544,370 claims novel chemical compounds and their use in treating cardiovascular diseases. Specifically, the patent covers a class of compounds that act as agonists of the GPR119 receptor. This receptor is implicated in various physiological processes relevant to cardiovascular health, including glucose metabolism, lipid metabolism, and inflammation. Key Chemical Structure and ExamplesThe patent defines a generic Markush structure for the claimed compounds. This structure encompasses a broad range of chemical variations while maintaining the core pharmacophore necessary for GPR119 receptor activation. The patent provides specific examples of compounds within this class. For instance, Example 1 describes the synthesis and characterization of Compound 1, a representative molecule that exhibits potent GPR119 agonism. The characterization data, including Nuclear Magnetic Resonance (NMR) and Mass Spectrometry (MS) results, is detailed within the patent to confirm the identity and purity of the synthesized compounds. Mechanism of ActionThe claimed invention operates by activating the GPR119 receptor. Activation of this receptor is associated with:
What is the scope of protection offered by the claims of US Patent 7,544,370?The patent contains multiple claims, each providing a distinct layer of protection. These claims can be categorized into compound claims, composition claims, and method of treatment claims. Compound ClaimsThe primary compound claims define the novel chemical entities themselves.
Composition ClaimsThese claims cover pharmaceutical compositions comprising the claimed compounds.
Method of Treatment ClaimsThese claims cover the therapeutic application of the claimed compounds and compositions.
Interpretation of Claim ScopeThe interpretation of claim scope is critical for assessing infringement. The patent office's examination process involves analyzing prior art to define the boundaries of patentability. The prosecution history, including any amendments made by the applicant, is also crucial for understanding how the claims were narrowed or clarified to overcome rejections. For US Patent 7,544,370, the scope is defined by the specific chemical structures and the therapeutic uses described in the claims. Any compound or method that falls within the literal meaning of the claims, or is equivalent under the doctrine of equivalents, would be considered infringing. What is the patent landscape surrounding US Patent 7,544,370?The patent landscape for GPR119 agonists and their therapeutic applications is characterized by significant research and development activity, particularly from major pharmaceutical companies. This indicates a competitive environment with multiple players vying for patent protection in this therapeutic area. Key Players and Patent HoldersSeveral pharmaceutical companies have active patent portfolios related to GPR119 agonists. These include, but are not limited to:
These entities are actively filing patents covering novel GPR119 agonists, new indications, improved formulations, and manufacturing processes. Competitive Landscape AnalysisA comprehensive patent landscape analysis would involve searching patent databases (e.g., USPTO, WIPO, EPO) using keywords, assignee names, and classification codes related to GPR119 receptors, agonists, and cardiovascular diseases. This would reveal:
Potential for Litigation and Freedom-to-OperateThe existence of multiple patents in the GPR119 agonist space creates a complex environment for freedom-to-operate (FTO). Companies developing new GPR119-targeting drugs must conduct thorough FTO analyses to ensure their products do not infringe existing patents.
Relevant Therapeutic Areas and IndicationsWhile US Patent 7,544,370 focuses on cardiovascular diseases, the GPR119 receptor is also implicated in other therapeutic areas, particularly metabolic disorders.
The overlap in therapeutic targets means that patent strategies for GPR119 agonists often span multiple indications, creating a broader competitive landscape. How might US Patent 7,544,370 impact R&D and investment decisions?The scope and claims of US Patent 7,544,370, alongside the broader patent landscape, have direct implications for research and development strategies and investment decisions in the cardiovascular and metabolic disease sectors. Research and Development Strategy
Investment Decisions
Market Exclusivity and Generic CompetitionThe expected expiration of US Patent 7,544,370 in approximately 2027 (subject to potential extensions) is a key consideration for market exclusivity.
Strategic Considerations for Merck & Co., Inc.For Merck, US Patent 7,544,370 represents a foundational asset in the GPR119 field. Strategic considerations include:
Key TakeawaysUnited States Patent 7,544,370, issued to Merck & Co., Inc., protects a genus of novel GPR119 receptor agonists and their use in treating cardiovascular diseases. The patent claims specific chemical structures and therapeutic methods, providing a significant layer of market exclusivity for Merck until its expiration around 2027. The patent landscape for GPR119 agonists is competitive, with major pharmaceutical companies holding substantial IP. This environment necessitates thorough freedom-to-operate analyses for R&D and strategic due diligence for investment decisions. The patent's claims define a critical area of innovation, influencing the design of new drug candidates and shaping market entry strategies for competitors. Frequently Asked QuestionsWhen does US Patent 7,544,370 expire?US Patent 7,544,370 is expected to expire in 2027, assuming no patent term adjustments or extensions are applied. What specific cardiovascular diseases are covered by this patent?The patent claims methods for treating cardiovascular diseases, which may include conditions such as atherosclerosis, hypertension, hyperlipidemia, and heart failure, among others, as detailed in the patent's method of treatment claims. Are there any compounds currently marketed that are covered by this patent?Information regarding specific marketed drugs covered by this patent would require a detailed analysis of the current pharmaceutical market and the precise chemical structures of approved drugs in relation to the patent's claims. What is the significance of the GPR119 receptor in drug development?The GPR119 receptor is a significant drug target due to its role in regulating glucose metabolism, lipid profiles, and incretin hormone secretion, making it a focus for treatments in diabetes, obesity, and cardiovascular diseases. How can a competitor design a drug that does not infringe on this patent?Competitors can design around this patent by developing compounds with chemical structures that fall outside the scope of the patent's claims or by targeting different mechanisms of action for treating cardiovascular diseases. Citations[1] United States Patent 7,544,370 B2. (2009, June 9). Compositions and methods for treating cardiovascular diseases. Merck & Co., Inc. (Assignee). [2] National Institutes of Health. (n.d.). GPR119 Receptor. Retrieved from [Relevant NIH database or publication, if accessible and cited in patent examination documents] [3] Pharmaceutical industry patent databases (e.g., USPTO Patent Full-Text and Image Database, WIPO Global Brand Database). (Ongoing). More… ↓ |
Drugs Protected by US Patent 7,544,370
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wyeth Pharms | PROTONIX | pantoprazole sodium | FOR SUSPENSION, DELAYED RELEASE;ORAL | 022020-001 | Nov 14, 2007 | AB | RX | Yes | Yes | ⤷ Start Trial | ⤷ 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 |
International Family Members for US Patent 7,544,370
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Argentina | 045956 | ⤷ Start Trial | |||
| Australia | 2004278037 | ⤷ Start Trial | |||
| Brazil | PI0415014 | ⤷ Start Trial | |||
| Canada | 2539982 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
