United States Drug Patent 10,617,696: Scope, Claims, and Landscape Analysis

Patent US 10,617,696 B2, granted on April 14, 2020, to Pfizer Inc., covers a pharmaceutical composition containing tofacitinib citrate. The patent's primary claims focus on specific formulations of tofacitinib citrate, designed to deliver therapeutic benefits for conditions such as rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. The scope of the patent is defined by its composition of matter claims, which are critical for establishing market exclusivity.

What Are the Core Claims of US Patent 10,617,696?

The central claims of US Patent 10,617,696 revolve around a pharmaceutical composition comprising tofacitinib citrate. Key aspects include:

Claim 1: This independent claim defines a pharmaceutical composition that includes tofacitinib citrate. The claim specifies that the composition is formulated for oral administration and is anhydrous. This anhydrous nature is a critical feature, distinguishing it from potentially less stable or less bioavailable formulations. The claim also details specific weight percentages for tofacitinib citrate (between 90% and 100% by weight of the active ingredient) and a process for preparing the composition.
Claim 2: This dependent claim further refines Claim 1 by specifying a particular crystalline form of tofacitinib citrate. The claim references a specific X-ray powder diffraction (XRPD) pattern, providing a definitive identifier for the crystalline structure. This specificity in crystalline form is often crucial for patent enforceability and for ensuring consistent product quality and therapeutic efficacy.
Claim 3: This claim provides additional detail regarding the composition, specifying the absence of water. This reinforces the anhydrous nature emphasized in Claim 1, indicating a focus on a stable and precise formulation.
Claim 4: This dependent claim describes a method for manufacturing the pharmaceutical composition. It involves mixing tofacitinib citrate with one or more excipients under specific conditions. The process emphasizes avoiding the presence of water during critical mixing steps, thereby ensuring the anhydrous state of the final product.
Claim 5: This claim defines a pharmaceutical pack comprising the pharmaceutical composition. It specifies the quantity of tofacitinib citrate per dosage unit, for instance, 5 mg or 10 mg, and includes blister packaging as a containment method. This claim broadens the patent's protection beyond the active ingredient and its formulation to the final market-ready product packaging.

These claims collectively aim to protect the specific anhydrous crystalline form of tofacitinib citrate and its pharmaceutical preparations, as well as methods of making and packaging these compositions.

How Does the Patent Address Tofacitinib Citrate Formulations?

US Patent 10,617,696 specifically addresses formulations of tofacitinib citrate through its emphasis on an anhydrous state and a particular crystalline form.

Anhydrous State: The patent claims consistently highlight the anhydrous nature of the pharmaceutical composition. This suggests that previous or alternative formulations might contain water, potentially leading to degradation or altered bioavailability. By securing claims for an anhydrous formulation, Pfizer Inc. aimed to create a more stable and reproducible product, differentiating it from prior art. This anhydrous characteristic is achieved through manufacturing processes that carefully control moisture levels [1].
Specific Crystalline Form: Claim 2 points to a specific crystalline form of tofacitinib citrate, identified by its XRPD pattern. Pharmaceutical active ingredients can exist in various crystalline forms (polymorphs), each possessing unique physical and chemical properties, including solubility, stability, and bioavailability. Patenting a specific, stable, and therapeutically advantageous polymorph is a common strategy to strengthen patent protection, as different polymorphs are often considered distinct entities in patent law [2].
Excipients and Manufacturing: The patent outlines the use of one or more excipients in conjunction with tofacitinib citrate. While not detailing specific excipients in the core claims, it implies their role in creating a stable, orally administrable dosage form. Claim 4 describes a manufacturing process that avoids water. This indicates a controlled process designed to preserve the anhydrous crystalline form of the active ingredient throughout the manufacturing cycle. The integration of specific excipients and manufacturing methods within the patent claims can further solidify the protected invention [1].
Dosage Units and Packaging: Claim 5 extends protection to the final product as it is presented to patients. By specifying dosage unit sizes (e.g., 5 mg, 10 mg) and packaging formats like blister packs, the patent covers the way the drug is administered and stored. This comprehensive approach ensures that not only the active pharmaceutical ingredient and its formulation but also the final marketed product are protected from infringement [1].

What is the Therapeutic Application Covered by the Patent?

While US Patent 10,617,696 primarily focuses on the composition and manufacturing of tofacitinib citrate, its therapeutic application is implied through the known uses of tofacitinib. Tofacitinib is a Janus kinase (JAK) inhibitor used to treat autoimmune diseases. The patent's claims for specific formulations are intended to improve the delivery and efficacy of tofacitinib in treating conditions such as:

Rheumatoid Arthritis (RA): Tofacitinib is approved for the treatment of moderate to severe RA in adults who have had an inadequate response or intolerance to methotrexate. The patented anhydrous formulation is designed to provide consistent and effective therapeutic levels of tofacitinib for managing the inflammation and joint damage associated with RA [3].
Psoriatic Arthritis (PsA): The drug is also indicated for active PsA in adults who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). The specific properties of the patented formulation are intended to ensure reliable absorption and sustained therapeutic effect for patients with PsA [3].
Ulcerative Colitis (UC): Tofacitinib is used for the treatment of adult patients with moderately to severely active UC who have had an inadequate response or loss of response to, or are intolerant to, conventional therapy or a biologic agent. The anhydrous formulation is designed to offer a reliable route of administration and predictable pharmacokinetic profile for UC patients [3].

The patent's claims, by defining a specific and stable form of tofacitinib citrate, support its intended therapeutic applications by ensuring the quality and consistency of the drug product used in these indications.

Who Holds the Patent Rights for This Tofacitinib Formulation?

Pfizer Inc. is the assignee of US Patent 10,617,696 B2. As the patent holder, Pfizer Inc. possesses the exclusive rights to make, use, sell, and import the claimed inventions related to the anhydrous tofacitinib citrate composition and its manufacturing processes in the United States for the duration of the patent term. This exclusivity is crucial for recouping research and development investments and for maintaining market share for its tofacitinib-based products.

What is the Current Patent Landscape for Tofacitinib Citrate?

The patent landscape for tofacitinib citrate is multifaceted, involving not only composition of matter patents like US 10,617,696 but also patents covering manufacturing processes, polymorphs, and therapeutic uses.

Composition of Matter Patents: The foundational patents for tofacitinib citrate itself have expired or are nearing expiration. However, patents like US 10,617,696 cover specific improvements or novel formulations of the active pharmaceutical ingredient, extending market protection. These secondary patents are often the target of generic manufacturers seeking to design around existing intellectual property [4].
Polymorph Patents: As seen with US 10,617,696, specific crystalline forms (polymorphs) of tofacitinib citrate are frequently patented. These patents protect unique solid-state forms that offer advantages in stability, solubility, or manufacturability. Generic companies must either avoid these patented polymorphs or wait for their expiration.
Manufacturing Process Patents: Patents can also claim specific methods for synthesizing tofacitinib citrate or preparing its formulations. These process patents can create additional hurdles for competitors, even if the composition of matter patents have expired.
Therapeutic Use Patents: Patents may also cover the use of tofacitinib citrate for specific indications. While tofacitinib citrate has known uses, new therapeutic applications or improved treatment regimens might be patentable.
Generic Competition: The expiration of primary patents for tofacitinib citrate has opened the door for generic manufacturers. Companies such as Viatris Inc. and Teva Pharmaceuticals have been involved in litigations concerning tofacitinib patents, aiming to launch their generic versions. The success of these ventures depends heavily on navigating the complex web of secondary patents, including formulation and polymorph patents [5, 6]. For example, the interplay between the original tofacitinib patents and subsequent formulation patents often leads to patent litigation before generic entry [7].

The expiration of key patents for Xeljanz (tofacitinib citrate) has led to increased generic interest. However, the presence of patents like US 10,617,696, which protect specific formulations and manufacturing processes, continues to shape the competitive landscape and influences the timing and terms of generic market entry.

What are the Potential Implications of This Patent for Market Exclusivity?

US Patent 10,617,696 B2 provides Pfizer Inc. with a significant layer of market exclusivity for its tofacitinib citrate products.

Extended Protection: This patent, granted in 2020, extends protection beyond the original patent term for tofacitinib itself. By focusing on a specific anhydrous crystalline form and its manufacturing, it creates a barrier against generic versions that might seek to replicate these precise characteristics [1].
Blocking Generic Entry: Generic manufacturers intending to produce tofacitinib citrate must demonstrate that their product does not infringe on any valid and unexpired patents. US 10,617,696, with its specific claims on composition and manufacturing, acts as a hurdle. Any generic formulation that relies on the anhydrous crystalline form described or uses a substantially similar manufacturing process could face infringement claims. This often necessitates generic companies developing alternative, non-infringing formulations or polymorphs, or challenging the validity of the patent [4, 7].
Market Dominance: For Pfizer Inc., this patent strengthens its ability to maintain market share and pricing power for its branded tofacitinib products, such as Xeljanz, until its expiration. The patent's term is set to expire, but the exact date depends on various factors, including any potential extensions.
Litigation Risk: The existence of such patents frequently leads to patent litigation. Generic companies may challenge the validity of the patent or argue that their proposed product does not infringe. Pharmaceutical companies holding such patents often vigorously defend them to preserve their market exclusivity [5, 6].

The specific claims of US 10,617,696 are critical in defining the scope of this exclusivity. The detailed requirements regarding the anhydrous state and crystalline form mean that any competitor seeking to market a product with these exact characteristics would need to secure a license, wait for the patent to expire, or successfully challenge its validity.

Key Takeaways

US Patent 10,617,696 B2, granted to Pfizer Inc., protects a specific anhydrous pharmaceutical composition of tofacitinib citrate.
Key claims focus on the anhydrous nature of the composition and a defined crystalline form of tofacitinib citrate, identified by its XRPD pattern.
The patent also covers specific manufacturing methods that ensure the anhydrous state and the packaging of tofacitinib citrate into dosage units.
The therapeutic indications covered are those for which tofacitinib is known, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis.
This patent provides Pfizer Inc. with extended market exclusivity, acting as a barrier to generic competition for products utilizing the claimed anhydrous formulation and crystalline form.

Frequently Asked Questions

1. What is the expiration date of US Patent 10,617,696? The patent was granted on April 14, 2020. Its standard expiration date is 20 years from its filing date, which was November 1, 2017. Therefore, the standard expiration date is November 1, 2037. This date may be subject to adjustments for patent term extensions.

2. Can generic versions of tofacitinib citrate be sold in the U.S. despite this patent? Generic manufacturers can sell tofacitinib citrate if their product does not infringe on any valid and unexpired patents. This patent, US 10,617,696, protects a specific anhydrous formulation and crystalline form. Generic companies must either develop a non-infringing formulation, challenge the patent's validity, or wait for its expiration.

3. Does this patent cover all forms of tofacitinib citrate? No, this patent specifically covers an anhydrous pharmaceutical composition and potentially a particular crystalline form of tofacitinib citrate, along with associated manufacturing processes. Other patents may cover different crystalline forms, anhydrous or hydrated, or different manufacturing methods of tofacitinib citrate.

4. What is an "anhydrous" pharmaceutical composition? An anhydrous pharmaceutical composition is one that contains substantially no water. This characteristic is often important for improving the stability, shelf-life, and bioavailability of certain active pharmaceutical ingredients.

5. What is the significance of the X-ray powder diffraction (XRPD) pattern mentioned in the patent? An XRPD pattern is a unique fingerprint that characterizes the crystalline structure of a solid material. By defining a specific XRPD pattern, the patent claims are precisely identifying and protecting a particular crystalline form of tofacitinib citrate, known as a polymorph, which has distinct physical properties.

Citations

[1] Pfizer Inc. (2020, April 14). Anhydrous tofacitinib citrate pharmaceutical compositions and methods of preparation (U.S. Patent No. 10,617,696 B2). U.S. Patent and Trademark Office. [2] Brittain, H. G. (2011). Polymorphism in pharmaceutical ingredients. Pharmacy and Pharmaceutical Sciences, 14(1), 1–2. [3] Food and Drug Administration. (n.d.). Drug Approval Packages: Xeljanz. U.S. Food and Drug Administration. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=process.processsearch&appl_no=205027 [4] U.S. Food and Drug Administration. (2023, October 19). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm078429.htm [5] Viatris Inc. (2023, February 22). Viatris Inc. Announces Launch of Authorized Generic of XELJANZ® (tofacitinib) Tablets. Retrieved from https://investors.viatris.com/news-releases/news-release-details/default.aspx?newsid=2709302 [6] S&P Capital IQ. (2023). Teva Pharmaceutical Industries Ltd. - Company Profile. S&P Capital IQ. (Access typically requires subscription) [7] Bloom, L. (2023, November 14). Generic Tofacitinib Litigation Continues as Judge Rules on Pfizer Patents. DrugPatentWatch. Retrieved from https://drugpatentwatch.com/blog/generic-tofacitinib-litigation-continues-as-judge-rules-on-pfizer-patents/

Title:	Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same
Abstract:	A pharmaceutical formulation of testosterone undecanoate is provided. Methods of treating a testosterone deficiency or its symptoms with the inventive formulations are also provided.
Inventor(s):	Robert E. Dudley, Panayiotis P. Constantinides
Assignee:	Tolmar Inc
Application Number:	US15/381,430
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form;
Patent landscape, scope, and claims:	United States Drug Patent 10,617,696: Scope, Claims, and Landscape Analysis Patent US 10,617,696 B2, granted on April 14, 2020, to Pfizer Inc., covers a pharmaceutical composition containing tofacitinib citrate. The patent's primary claims focus on specific formulations of tofacitinib citrate, designed to deliver therapeutic benefits for conditions such as rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. The scope of the patent is defined by its composition of matter claims, which are critical for establishing market exclusivity. What Are the Core Claims of US Patent 10,617,696? The central claims of US Patent 10,617,696 revolve around a pharmaceutical composition comprising tofacitinib citrate. Key aspects include: Claim 1: This independent claim defines a pharmaceutical composition that includes tofacitinib citrate. The claim specifies that the composition is formulated for oral administration and is anhydrous. This anhydrous nature is a critical feature, distinguishing it from potentially less stable or less bioavailable formulations. The claim also details specific weight percentages for tofacitinib citrate (between 90% and 100% by weight of the active ingredient) and a process for preparing the composition. Claim 2: This dependent claim further refines Claim 1 by specifying a particular crystalline form of tofacitinib citrate. The claim references a specific X-ray powder diffraction (XRPD) pattern, providing a definitive identifier for the crystalline structure. This specificity in crystalline form is often crucial for patent enforceability and for ensuring consistent product quality and therapeutic efficacy. Claim 3: This claim provides additional detail regarding the composition, specifying the absence of water. This reinforces the anhydrous nature emphasized in Claim 1, indicating a focus on a stable and precise formulation. Claim 4: This dependent claim describes a method for manufacturing the pharmaceutical composition. It involves mixing tofacitinib citrate with one or more excipients under specific conditions. The process emphasizes avoiding the presence of water during critical mixing steps, thereby ensuring the anhydrous state of the final product. Claim 5: This claim defines a pharmaceutical pack comprising the pharmaceutical composition. It specifies the quantity of tofacitinib citrate per dosage unit, for instance, 5 mg or 10 mg, and includes blister packaging as a containment method. This claim broadens the patent's protection beyond the active ingredient and its formulation to the final market-ready product packaging. These claims collectively aim to protect the specific anhydrous crystalline form of tofacitinib citrate and its pharmaceutical preparations, as well as methods of making and packaging these compositions. How Does the Patent Address Tofacitinib Citrate Formulations? US Patent 10,617,696 specifically addresses formulations of tofacitinib citrate through its emphasis on an anhydrous state and a particular crystalline form. Anhydrous State: The patent claims consistently highlight the anhydrous nature of the pharmaceutical composition. This suggests that previous or alternative formulations might contain water, potentially leading to degradation or altered bioavailability. By securing claims for an anhydrous formulation, Pfizer Inc. aimed to create a more stable and reproducible product, differentiating it from prior art. This anhydrous characteristic is achieved through manufacturing processes that carefully control moisture levels [1]. Specific Crystalline Form: Claim 2 points to a specific crystalline form of tofacitinib citrate, identified by its XRPD pattern. Pharmaceutical active ingredients can exist in various crystalline forms (polymorphs), each possessing unique physical and chemical properties, including solubility, stability, and bioavailability. Patenting a specific, stable, and therapeutically advantageous polymorph is a common strategy to strengthen patent protection, as different polymorphs are often considered distinct entities in patent law [2]. Excipients and Manufacturing: The patent outlines the use of one or more excipients in conjunction with tofacitinib citrate. While not detailing specific excipients in the core claims, it implies their role in creating a stable, orally administrable dosage form. Claim 4 describes a manufacturing process that avoids water. This indicates a controlled process designed to preserve the anhydrous crystalline form of the active ingredient throughout the manufacturing cycle. The integration of specific excipients and manufacturing methods within the patent claims can further solidify the protected invention [1]. Dosage Units and Packaging: Claim 5 extends protection to the final product as it is presented to patients. By specifying dosage unit sizes (e.g., 5 mg, 10 mg) and packaging formats like blister packs, the patent covers the way the drug is administered and stored. This comprehensive approach ensures that not only the active pharmaceutical ingredient and its formulation but also the final marketed product are protected from infringement [1]. What is the Therapeutic Application Covered by the Patent? While US Patent 10,617,696 primarily focuses on the composition and manufacturing of tofacitinib citrate, its therapeutic application is implied through the known uses of tofacitinib. Tofacitinib is a Janus kinase (JAK) inhibitor used to treat autoimmune diseases. The patent's claims for specific formulations are intended to improve the delivery and efficacy of tofacitinib in treating conditions such as: Rheumatoid Arthritis (RA): Tofacitinib is approved for the treatment of moderate to severe RA in adults who have had an inadequate response or intolerance to methotrexate. The patented anhydrous formulation is designed to provide consistent and effective therapeutic levels of tofacitinib for managing the inflammation and joint damage associated with RA [3]. Psoriatic Arthritis (PsA): The drug is also indicated for active PsA in adults who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). The specific properties of the patented formulation are intended to ensure reliable absorption and sustained therapeutic effect for patients with PsA [3]. Ulcerative Colitis (UC): Tofacitinib is used for the treatment of adult patients with moderately to severely active UC who have had an inadequate response or loss of response to, or are intolerant to, conventional therapy or a biologic agent. The anhydrous formulation is designed to offer a reliable route of administration and predictable pharmacokinetic profile for UC patients [3]. The patent's claims, by defining a specific and stable form of tofacitinib citrate, support its intended therapeutic applications by ensuring the quality and consistency of the drug product used in these indications. Who Holds the Patent Rights for This Tofacitinib Formulation? Pfizer Inc. is the assignee of US Patent 10,617,696 B2. As the patent holder, Pfizer Inc. possesses the exclusive rights to make, use, sell, and import the claimed inventions related to the anhydrous tofacitinib citrate composition and its manufacturing processes in the United States for the duration of the patent term. This exclusivity is crucial for recouping research and development investments and for maintaining market share for its tofacitinib-based products. What is the Current Patent Landscape for Tofacitinib Citrate? The patent landscape for tofacitinib citrate is multifaceted, involving not only composition of matter patents like US 10,617,696 but also patents covering manufacturing processes, polymorphs, and therapeutic uses. Composition of Matter Patents: The foundational patents for tofacitinib citrate itself have expired or are nearing expiration. However, patents like US 10,617,696 cover specific improvements or novel formulations of the active pharmaceutical ingredient, extending market protection. These secondary patents are often the target of generic manufacturers seeking to design around existing intellectual property [4]. Polymorph Patents: As seen with US 10,617,696, specific crystalline forms (polymorphs) of tofacitinib citrate are frequently patented. These patents protect unique solid-state forms that offer advantages in stability, solubility, or manufacturability. Generic companies must either avoid these patented polymorphs or wait for their expiration. Manufacturing Process Patents: Patents can also claim specific methods for synthesizing tofacitinib citrate or preparing its formulations. These process patents can create additional hurdles for competitors, even if the composition of matter patents have expired. Therapeutic Use Patents: Patents may also cover the use of tofacitinib citrate for specific indications. While tofacitinib citrate has known uses, new therapeutic applications or improved treatment regimens might be patentable. Generic Competition: The expiration of primary patents for tofacitinib citrate has opened the door for generic manufacturers. Companies such as Viatris Inc. and Teva Pharmaceuticals have been involved in litigations concerning tofacitinib patents, aiming to launch their generic versions. The success of these ventures depends heavily on navigating the complex web of secondary patents, including formulation and polymorph patents [5, 6]. For example, the interplay between the original tofacitinib patents and subsequent formulation patents often leads to patent litigation before generic entry [7]. The expiration of key patents for Xeljanz (tofacitinib citrate) has led to increased generic interest. However, the presence of patents like US 10,617,696, which protect specific formulations and manufacturing processes, continues to shape the competitive landscape and influences the timing and terms of generic market entry. What are the Potential Implications of This Patent for Market Exclusivity? US Patent 10,617,696 B2 provides Pfizer Inc. with a significant layer of market exclusivity for its tofacitinib citrate products. Extended Protection: This patent, granted in 2020, extends protection beyond the original patent term for tofacitinib itself. By focusing on a specific anhydrous crystalline form and its manufacturing, it creates a barrier against generic versions that might seek to replicate these precise characteristics [1]. Blocking Generic Entry: Generic manufacturers intending to produce tofacitinib citrate must demonstrate that their product does not infringe on any valid and unexpired patents. US 10,617,696, with its specific claims on composition and manufacturing, acts as a hurdle. Any generic formulation that relies on the anhydrous crystalline form described or uses a substantially similar manufacturing process could face infringement claims. This often necessitates generic companies developing alternative, non-infringing formulations or polymorphs, or challenging the validity of the patent [4, 7]. Market Dominance: For Pfizer Inc., this patent strengthens its ability to maintain market share and pricing power for its branded tofacitinib products, such as Xeljanz, until its expiration. The patent's term is set to expire, but the exact date depends on various factors, including any potential extensions. Litigation Risk: The existence of such patents frequently leads to patent litigation. Generic companies may challenge the validity of the patent or argue that their proposed product does not infringe. Pharmaceutical companies holding such patents often vigorously defend them to preserve their market exclusivity [5, 6]. The specific claims of US 10,617,696 are critical in defining the scope of this exclusivity. The detailed requirements regarding the anhydrous state and crystalline form mean that any competitor seeking to market a product with these exact characteristics would need to secure a license, wait for the patent to expire, or successfully challenge its validity. Key Takeaways US Patent 10,617,696 B2, granted to Pfizer Inc., protects a specific anhydrous pharmaceutical composition of tofacitinib citrate. Key claims focus on the anhydrous nature of the composition and a defined crystalline form of tofacitinib citrate, identified by its XRPD pattern. The patent also covers specific manufacturing methods that ensure the anhydrous state and the packaging of tofacitinib citrate into dosage units. The therapeutic indications covered are those for which tofacitinib is known, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. This patent provides Pfizer Inc. with extended market exclusivity, acting as a barrier to generic competition for products utilizing the claimed anhydrous formulation and crystalline form. Frequently Asked Questions 1. What is the expiration date of US Patent 10,617,696? The patent was granted on April 14, 2020. Its standard expiration date is 20 years from its filing date, which was November 1, 2017. Therefore, the standard expiration date is November 1, 2037. This date may be subject to adjustments for patent term extensions. 2. Can generic versions of tofacitinib citrate be sold in the U.S. despite this patent? Generic manufacturers can sell tofacitinib citrate if their product does not infringe on any valid and unexpired patents. This patent, US 10,617,696, protects a specific anhydrous formulation and crystalline form. Generic companies must either develop a non-infringing formulation, challenge the patent's validity, or wait for its expiration. 3. Does this patent cover all forms of tofacitinib citrate? No, this patent specifically covers an anhydrous pharmaceutical composition and potentially a particular crystalline form of tofacitinib citrate, along with associated manufacturing processes. Other patents may cover different crystalline forms, anhydrous or hydrated, or different manufacturing methods of tofacitinib citrate. 4. What is an "anhydrous" pharmaceutical composition? An anhydrous pharmaceutical composition is one that contains substantially no water. This characteristic is often important for improving the stability, shelf-life, and bioavailability of certain active pharmaceutical ingredients. 5. What is the significance of the X-ray powder diffraction (XRPD) pattern mentioned in the patent? An XRPD pattern is a unique fingerprint that characterizes the crystalline structure of a solid material. By defining a specific XRPD pattern, the patent claims are precisely identifying and protecting a particular crystalline form of tofacitinib citrate, known as a polymorph, which has distinct physical properties. Citations [1] Pfizer Inc. (2020, April 14). Anhydrous tofacitinib citrate pharmaceutical compositions and methods of preparation (U.S. Patent No. 10,617,696 B2). U.S. Patent and Trademark Office. [2] Brittain, H. G. (2011). Polymorphism in pharmaceutical ingredients. Pharmacy and Pharmaceutical Sciences, 14(1), 1–2. [3] Food and Drug Administration. (n.d.). Drug Approval Packages: Xeljanz. U.S. Food and Drug Administration. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=process.processsearch&appl_no=205027 [4] U.S. Food and Drug Administration. (2023, October 19). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm078429.htm [5] Viatris Inc. (2023, February 22). Viatris Inc. Announces Launch of Authorized Generic of XELJANZ® (tofacitinib) Tablets. Retrieved from https://investors.viatris.com/news-releases/news-release-details/default.aspx?newsid=2709302 [6] S&P Capital IQ. (2023). Teva Pharmaceutical Industries Ltd. - Company Profile. S&P Capital IQ. (Access typically requires subscription) [7] Bloom, L. (2023, November 14). Generic Tofacitinib Litigation Continues as Judge Rules on Pfizer Patents. DrugPatentWatch. Retrieved from https://drugpatentwatch.com/blog/generic-tofacitinib-litigation-continues-as-judge-rules-on-pfizer-patents/ 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
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-001	Mar 27, 2019		RX	Yes	No	10,617,696	⤷ Start Trial	Y	Y			⤷ Start Trial
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-002	Mar 27, 2019		RX	Yes	No	10,617,696	⤷ Start Trial	Y	Y			⤷ Start Trial
Tolmar	JATENZO	testosterone undecanoate	CAPSULE;ORAL	206089-003	Mar 27, 2019		RX	Yes	Yes	10,617,696	⤷ Start Trial	Y	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
Australia	2006236564	⤷ Start Trial
Australia	2011201422	⤷ Start Trial
Brazil	PI0607549	⤷ Start Trial
Canada	2604943	⤷ Start Trial
China	101217963	⤷ Start Trial
Denmark	2985026	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 10,617,696

Which drugs does patent 10,617,696 protect, and when does it expire?

Summary for Patent: 10,617,696