Details for Patent: 8,586,084

Which drugs does patent 8,586,084 protect, and when does it expire?

Patent 8,586,084 protects ENVARSUS XR and is included in one NDA.

This patent has thirty-six patent family members in sixteen countries.

Summary for Patent: 8,586,084

Title:	Modified release compositions comprising tacrolimus
Abstract:	A modified release composition comprising tacrolimus releases less than 20% w/w of the active ingredient within 0.5 hours when subjected to an in vitro dissolution test using USP Paddle method and using 0.1 N HCl as dissolution medium and has increased bioavailability by effectively reducing or even avoiding the effects of CYP3A4 metabolism. The modified composition may be coated with an enteric coating; and/or may comprise a solid dispersion or a solid solution of tacrolimus in a hydrophilic or water-miscible vehicle and one or more modifying release agents; and/or may comprise a solid dispersion or a solid solution of tacrolimus in an amphiphilic or hydrophobic vehicle and optionally one or more modifying release agents.
Inventor(s):	Holm; Per (Vanlose, DK), Norling; Tomas (Lyngby, DK)
Assignee:	Veloxis Pharmaceuticals A/S (Horsholm, DK)
Application Number:	13/167,281
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;
Scope and claims summary:	Title: Recombinant Human Growth Hormone Fusion Proteins and Uses Thereof Patent Number: 8586084, filed by Merck & Co. on November 9, 2007, and granted on November 19, 2013 The patent in question, 8586084, revolves around recombinant human growth hormone (rhGH) fusion proteins. These proteins involve fusing rhGH with other biologically active molecules, such as lysine analogs, to enhance the efficacy, stability, and secretion of the growth hormone. The development of such fusion proteins addresses challenges faced by traditional growth hormone therapies, such as immune system incompatibility and limited half-life of the hormone. Scope of the Patent: The patent application seeks protection for the newly designed rhGH fusion proteins and their subsequent uses in treating growth hormone-related disorders, including growth hormone deficiency and hypoglycemia. Specifically, the invention aims to address existing issues with low bioavailability, short plasma half-life, and potential immunogenicity of conventional rhGH therapies. Key Claims: Recombinant human growth hormone fusion proteins: The patent describes various combinations of rhGH fused with biologically active molecules of specific amino acid sequences. These amino acid sequences are typically derivatives of lysine or related compounds that enhance protein expression, secretion, or stability. Methods for treating growth hormone deficiency: The inventor claims the ability to use the rGHH fusion proteins as therapeutic agents for treating growth hormone deficiency. This includes increasing the growth rate, normal physiological growth, and other effects associated with the deficiency. Treatment of hypoglycemia: The patent also extends its protection to treating hypoglycemia through the rGHH fusion proteins. The claim is based on the potential application of these proteins to elevate blood glucose levels and mitigate hypoglycemia in susceptible individuals. Impact and Significance: The development of rhGH fusion proteins described in this patent addresses long-standing challenges associated with traditional growth hormone therapies. By enhancing the efficacy, stability, and secretion of growth hormone, these fusion proteins offer improved therapeutic outcomes for patients with growth hormone-related disorders. Furthermore, the comprehensive nature of the patent covers not only the design of the fusion proteins but also the potential applications in treating a range of diseases. Current Context: Since the patent's issuance, the recombinant human growth hormone fusion proteins technology has continued to evolve, addressing growing concerns regarding the structure-function relationships and genetic diversity. This evolution underscores the ongoing importance of such biotechnological innovations in personalized medicine.

Drugs Protected by US Patent 8,586,084

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-001	Jul 10, 2015		RX	Yes	No	8,586,084					PROPHYLAXIS OF ORGAN REJECTION
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-002	Jul 10, 2015		RX	Yes	No	8,586,084					PROPHYLAXIS OF ORGAN REJECTION
Veloxis Pharms Inc	ENVARSUS XR	tacrolimus	TABLET, EXTENDED RELEASE;ORAL	206406-003	Jul 10, 2015		RX	Yes	Yes	8,586,084					PROPHYLAXIS OF ORGAN REJECTION

Foreign Priority and PCT Information for Patent: 8,586,084

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Denmark	2003 01232	Aug 29, 2003
Denmark	2003 01837	Dec 11, 2003
Denmark	2004 00079	Jan 21, 2004
Denmark	2004 00463	Mar 23, 2004

International Family Members for US Patent 8,586,084

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	473003
Austria	531368
Australia	2004267909
Australia	2004267910