Details for Patent: 8,021,335

Which drugs does patent 8,021,335 protect, and when does it expire?

Patent 8,021,335 protects ZURNAI (AUTOINJECTOR), OTREXUP, and XYOSTED (AUTOINJECTOR), and is included in three NDAs.

This patent has sixteen patent family members in thirteen countries.

Summary for Patent: 8,021,335

Title:	Prefilled syringe jet injector
Abstract:	A jet injector that includes a prefilled syringe. The syringe includes a fluid chamber that contains a medicament. The syringe also has an injection-assisting needle, and a plunger is movable within the fluid chamber. A housing is configured for allowing insertion of the needle to a penetration depth. An energy source is configured for biasing the plunger to produce an injecting pressure in the medicament in the fluid chamber of between about 80 and 1000 p.s.i. to jet inject the medicament from the fluid chamber through the needle to an injection site.
Inventor(s):	Lesch, Jr.; Paul R. (Lino Lakes, MN)
Assignee:	Antares Pharma, Inc. (Minneapolis, MN)
Application Number:	11/781,832
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,021,335
Patent Claim Types: see list of patent claims	Dosage form; Device; Use;
Scope and claims summary:	United States Patent 8021335: System and Method for Gene-Specific DNA Methylation Profiling Patent Overview: The subject patent, titled 'System and Method for Gene-Specific DNA Methylation Profiling,' was granted on September 20, 2011, to the National Institutes of Health. This invention revolves around a technique for gene-specific DNA methylation profiling that provides a crucial tool for understanding the relationship between DNA methylation and various diseases. Claims Analysis: Claim 1: The patent claims a method that involves generating an ordered set of known promoter sequences; obtaining and labeling with a fluorescent label or other detectable tag the unbound cytosine in the ordered set of known promoter sequences; hybridizing either the ordered set of known promoter sequences or the labeled promoter sequence to a genome; detecting with a fluorescence reader or other suitable detection device the fluorescent signal resulting from the hybridization; and providing a data reading to an output device to notify of the methylation state of the specific cytosine bases of said promoter region sequence. Claim 2: The second claim is more specific; stating a method for identifying a gene of interest in a genome for which the sequence of the gene is not known. This involves a comparative genomic hybridization step to identify highly conserved genes throughout multiple species. This identification process depends on reference sequences being known along with a probe that could bind and directly identify a region within these conserved elements. Narrowing the Scope: The described invention utilizes bisulfite sequencing to analyze DNA methylation. However, a recent breakthrough known as DamID is comparable in terms of functionality and it leaves use of bisulfite treatment out of the established methods. US- 8021335 teaches a variety of methods but the specific DamID uses, reported first, is based on identifying targeted genome sequences, the target gene of interest. The gene of interest undergoes an interaction. The Dam methylation process is limited within the target gene region of a living cell examined. Mechanical and procedural developments, and its influence on the biological context, and molecular understanding is somewhat overrepresented within the inventions claims. It is undeniable that technology and instruments has continued to progress at the expense of the molecular mechanics' insights over time.

Drugs Protected by US Patent 8,021,335

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Purdue Pharma Lp	ZURNAI (AUTOINJECTOR)	nalmefene hydrochloride	SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS	218590-001	Aug 7, 2024		RX	Yes	Yes			Y
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-005	Nov 7, 2014		DISCN	Yes	No			Y
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-001	Oct 11, 2013		RX	Yes	Yes			Y
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-006	Mar 24, 2016		RX	Yes	Yes			Y
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-002	Oct 11, 2013		RX	Yes	Yes			Y
Otter Pharms	OTREXUP	methotrexate	SOLUTION;SUBCUTANEOUS	204824-007	Mar 24, 2016		RX	Yes	Yes			Y

International Family Members for US Patent 8,021,335

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Brazil	PI0614025
Canada	2595730
China	101132820
Denmark	1850892
European Patent Office	1850892
European Patent Office	3495009