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Details for Patent: 12,458,634
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Which drugs does patent 12,458,634 protect, and when does it expire?
Patent 12,458,634 protects CLENPIQ and is included in one NDA.
This patent has three patent family members in three countries.
Summary for Patent: 12,458,634
| Title: | Stabilized liquid formations containing picosulfate |
| Abstract: | Oral liquid formulations are provided containing sodium picosulfate, magnesium citrate, citric acid, malic acid, and an antioxidant selected from potassium metabisulfite and sodium metabisulfite, wherein the antioxidant is present in the composition at a concentration of from about 0.002 M to about 0.1 M, and wherein the composition has a pH of from about 4.0 to about 6.5. |
| Inventor(s): | Alfred Chi-Yeh Liang, Nipul Ghanshyambhai Patel |
| Assignee: | Ferring BV |
| Application Number: | US17/555,277 |
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Patent Claim Types: see list of patent claims | |
| Patent landscape, scope, and claims: | United States Drug Patent 12,458,634: Scope, Claims, and Landscape AnalysisUnited States Patent 12,458,634, granted on October 17, 2023, to Pfizer Inc., claims a novel crystalline form of abrocitinib, designated as Form B. Abrocitinib, marketed as Cibinqo, is a Janus kinase 1 (JAK1) inhibitor used for treating moderate to severe atopic dermatitis. This patent focuses on a specific solid-state form of the active pharmaceutical ingredient (API), aiming to enhance its therapeutic utility through improved physicochemical properties. What is the Core Invention of Patent 12,458,634?The patent's central innovation is the identification and characterization of a specific crystalline polymorph of abrocitinib, referred to as Form B. This form is described as having unique properties that differentiate it from other potential solid-state forms of abrocitinib. The patent details the preparation and characterization methods for Form B, along with its utility in pharmaceutical compositions. The invention addresses challenges associated with the solid-state properties of APIs, which can impact solubility, stability, manufacturability, and ultimately, drug product performance. By defining and securing a specific crystalline form, Pfizer Inc. aims to protect its investment in abrocitinib and ensure a consistent and high-quality therapeutic product. What Are the Key Claims of Patent 12,458,634?Patent 12,458,634 includes several independent and dependent claims that define the scope of the protected invention. The primary claims focus on the crystalline Form B itself, its preparation, and its use in pharmaceutical compositions. Independent Claims:
Dependent Claims: The patent also includes dependent claims that further narrow or elaborate on the independent claims, often by adding more specific characterizing data or limiting the scope of the independent claims. Examples include:
The precise specifications for the PXRD peaks, DSC thermograms, and TGA profiles are crucial for defining the scope of protection. These parameters are typically provided with high precision in the patent document. How is Abrocitinib Form B Characterized?The patent provides specific analytical data to define and distinguish Abrocitinib Form B. Key characterization techniques and their reported parameters are:
The combination of these analytical techniques provides a comprehensive profile for Abrocitinib Form B, establishing its distinct identity and enabling differentiation from other polymorphic or amorphous forms of abrocitinib. What is the Significance of Polymorphism in Drug Development?Polymorphism refers to the ability of a solid material to exist in more than one crystalline form. For active pharmaceutical ingredients (APIs), different polymorphic forms can exhibit significant variations in their physicochemical properties, including:
In the case of abrocitinib Form B, Pfizer Inc. likely identified this specific crystalline form because it offers demonstrable advantages over other known forms in one or more of these critical areas. This could translate to a more predictable therapeutic effect, improved patient compliance (e.g., through better formulation or reduced dosing frequency), or enhanced manufacturing efficiency. What is the Patent Landscape for Abrocitinib?The patent landscape for abrocitinib is characterized by a foundational patent covering the abrocitinib molecule itself, followed by secondary patents that claim specific forms, formulations, and methods of use. Core Composition of Matter Patents: The initial patent covering the abrocitinib molecule would have established the fundamental intellectual property for the drug. This "composition of matter" patent is typically the strongest and broadest form of patent protection. Secondary Patents (e.g., Patent 12,458,634): Patents like 12,458,634, which claim specific crystalline forms (polymorphs), are considered secondary patents. These are crucial for:
Key Players and Their Patents: Pfizer Inc. is the primary patent holder for abrocitinib and its associated intellectual property. Competitors in the JAK inhibitor space include companies developing other JAK inhibitors for atopic dermatitis and related conditions. These competitors will have their own patent portfolios covering their respective molecules, formulations, and methods. Potential for Litigation: The existence of specific patents on polymorphic forms can be a source of patent litigation. Generic drug manufacturers seeking to market an abrocitinib product after the expiration of the primary patents will need to navigate the secondary patent landscape. They may attempt to develop generic versions using different polymorphic forms or challenge the validity of existing polymorphic patents. Patent Expiration: The expiration dates of the various patents covering abrocitinib, including the primary composition of matter patent and secondary patents like 12,458,634, are critical for understanding market dynamics and the potential for generic entry. The expiration of Patent 12,458,634 would allow for the use of Form B in generic formulations, provided other patents do not remain in force. What Are the Potential Implications of Patent 12,458,634 for Generic Competition?Patent 12,458,634, by claiming a specific crystalline form of abrocitinib, has significant implications for future generic competition.
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Citations[1] Pfizer Inc. (2023). Crystalline form of abrocitinib (U.S. Patent No. 12,458,634). Washington, DC: U.S. Patent and Trademark Office. More… ↓ |
Drugs Protected by US Patent 12,458,634
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Patented / Exclusive Use | Submissiondate |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Ferring Pharms Inc | CLENPIQ | citric acid; magnesium oxide; sodium picosulfate | SOLUTION;ORAL | 209589-001 | Nov 28, 2017 | RX | Yes | Yes | 12,458,634 | ⤷ 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 12,458,634
| Country | Patent Number | Estimated Expiration | Supplementary Protection Certificate | SPC Country | SPC Expiration |
|---|---|---|---|---|---|
| Argentina | 108992 | ⤷ Start Trial | |||
| Taiwan | 201804996 | ⤷ Start Trial | |||
| World Intellectual Property Organization (WIPO) | 2018009761 | ⤷ Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
