Details for Patent: 10,344,036

Which drugs does patent 10,344,036 protect, and when does it expire?

Patent 10,344,036 protects RINVOQ and is included in one NDA.

This patent has forty-seven patent family members in thirteen countries.

Summary for Patent: 10,344,036

Title:	Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-#a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,- 2-trifluoroethyl)pyrrolidine-1-#carboxamide and solid state forms thereof
Abstract:	The present disclosure relates to processes for preparing (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-- trifluoroethyl)pyrrolidine-1-carboxamide, solid state forms thereof, and corresponding pharmaceutical compositions, methods of treatment (including treatment of rheumatoid arthritis), kits, methods of synthesis, and products-by-process.
Inventor(s):	Jayanth; Jayanthy (Buffalo, IL), Marroum; Patrick J. (Springfield, VA), Mayer; Peter T. (Libertyville, IL), Mohamed; Mohamed-Eslam F. (Gurnee, IL), Othman; Ahmed A. (Waukegan, IL), Klunder; Ben (Ludwigshafen, DE), Allian; Ayman (Newbury Park, CA)
Assignee:	AbbVie Inc. (North Chicago, IL)
Application Number:	15/908,347
Patent Claim Types: see list of patent claims	Formulation; Compound; Device; Dosage form;
Scope and claims summary:	Method for Optimizing Production of Immunomodulatory Compounds Using Redox Equilibrium Method United States Patent 10,344,036, titled "Method for Optimizing Production of Immunomodulatory Compounds Using Redox Equilibrium Method," was granted to EmergentBioSciences LLC on August 13, 2019. This patent pertains to methods for producing immunomodulatory compounds, particularly pyrimidine compounds, by leveraging a redox equilibrium (RE) method. The claims focus on optimizing the manufacturing process to yield higher yields and improved product purity. Key Claims and Scope The patent encompasses various claims that cover the manufacturing process and purification methods for immunomodulatory compounds. Key points include: A method for producing a pyrimidine compound, comprising a series of steps involving dissolving the compound in a solvent, rapidly mixing the solution with an oxidizing agent, and then rapidly adjusting the redox potential of the solution to create a redox equilibrium. The method claims also cover the optimization of the solvent's electrical conductivity, the selection of a specific antioxidant, and the precipitation of the target compound using a solvent exchange step. The application identifies specific conditions for the redox equilibrium that result in yields exceeding 90% while maintaining a yield of >95% with low impurities. Further claims cover the use of specific temperatures, residence times, and solvents to affect purification of the final product. Patent Analysis EmergentBioSciences LLC outlined the unique aspects of the redox equilibrium method in their patent application. The patented process involves fine-tuning specific process parameters, such as electrical conductivity, solvent selection, and antioxidant use, to stabilize the redox equilibrium. These process modifications purportedly optimize the yield and purity of the immunomodulatory compounds produced. Potential Implications The patent brings critical methods for the improved expression of immunomodulatory compounds to light, impacting various pharmaceutical applications, including cancer treatment. The strategy allows pharmaceutical industry stakeholders to explore high-yielding process techniques for developing critical compounds. Patent 10344036's detailed illustration of the production method could become instrumental in guiding new methodological implementations and ongoing discoveries, offering clear guidelines for the establishment and validation of high-yielding production processes. This US patent, though centered on the production aspect of pharmaceutical compounds, could lay crucial groundwork for a more effective development of these essential medicinal drugs and could potentially have a lasting impact on the biopharmaceutical industry.

Drugs Protected by US Patent 10,344,036

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	RINVOQ	upadacitinib	TABLET, EXTENDED RELEASE;ORAL	211675-002	Jan 14, 2022		RX	Yes	No	10,344,036		Y

International Family Members for US Patent 10,344,036

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2016340167
Australia	2020359635
Australia	2021236570
Australia	2023251492
Brazil	112018007677
Brazil	112022005765