Details for New Drug Application (NDA): 206627

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NDA 206627 describes HYSINGLA ER, which is a drug marketed by Knoa Pharma and is included in one NDA. It is available from one supplier. There are nineteen patents protecting this drug and two Paragraph IV challenges. Additional details are available on the HYSINGLA ER profile page.

The generic ingredient in HYSINGLA ER is hydrocodone bitartrate. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the hydrocodone bitartrate profile page.

Summary for 206627

Tradename:	HYSINGLA ER
Applicant:	Knoa Pharma
Ingredient:	hydrocodone bitartrate
Patents:	19

Pharmacology for NDA: 206627

Mechanism of Action

Opioid Agonists

Medical Subject Heading (MeSH) Categories for 206627

Analgesics, Opioid

Antitussive Agents

Narcotics

Suppliers and Packaging for NDA: 206627

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627	NDA	Knoa Pharma LLC	59011-271	59011-271-60	60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-271-60)
HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627	NDA	Knoa Pharma LLC	59011-272	59011-272-60	60 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (59011-272-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	20MG
Approval Date:	Nov 20, 2014	TE:	AB	RLD:	Yes
Patent:	11,304,908	Patent Expiration:	Aug 24, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	11,304,909	Patent Expiration:	Aug 24, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE
Patent:	8,808,740	Patent Expiration:	Dec 21, 2031	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE

Expired US Patents for NDA 206627

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-005	Nov 20, 2014	9,675,611
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	8,647,667
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014	9,056,052
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014	9,023,401
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014	10,130,591
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	6,488,963
Knoa Pharma	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014	9,675,610

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