Dyloject Drug Patent Profile

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Which patents cover Dyloject, and when can generic versions of Dyloject launch?

Dyloject is a drug marketed by Javelin Pharms Inc and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-four patent family members in eleven countries.

The generic ingredient in DYLOJECT is diclofenac sodium. There are forty-seven drug master file entries for this compound. One hundred and twenty-five suppliers are listed for this compound. Additional details are available on the diclofenac sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dyloject

A generic version of Dyloject was approved as diclofenac sodium by ACTAVIS ELIZABETH on March 26^th, 1996.

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Summary for Dyloject

International Patents:	24
US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	121
Patent Applications:	3,851
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for Dyloject
DailyMed Link:	Dyloject at DailyMed

Drug patent expirations by year for Dyloject

Paragraph IV (Patent) Challenges for DYLOJECT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DYLOJECT	Injection	diclofenac sodium	37.5 mg/mL, 1 mL single-dose vials	022396	1	2015-12-15

US Patents and Regulatory Information for Dyloject

Dyloject is protected by one US patents.

Patents protecting Dyloject

Formulations of low dose diclofenac and beta-cyclodextrin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MANAGEMENT OF PAIN

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Javelin Pharms Inc	DYLOJECT	diclofenac sodium	SOLUTION;INTRAVENOUS	022396-001	Dec 23, 2014		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for Dyloject

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Javelin Pharms Inc	DYLOJECT	diclofenac sodium	SOLUTION;INTRAVENOUS	022396-001	Dec 23, 2014	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for Dyloject

See the table below for patents covering Dyloject around the world.

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Country	Patent Number	Title	Estimated Expiration
South Korea	20160033796	저 복용량의 디클로페낙 및 베타-사이클로덱스트린 제형 (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN)	⤷ Try a Trial
Japan	6265964		⤷ Try a Trial
Japan	2009531450		⤷ Try a Trial
China	101410123	Formulations of low dose diclofenac and beta-cyclodextrin	⤷ Try a Trial
Canada	2647348	FORMULATIONS DE DICLOFENAC ET DE CYCLODEXTRINE BETA A FAIBLEDOSAGE (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration