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Purdue Pharma Company Profile

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What is the competitive landscape for PURDUE PHARMA, and what generic alternatives to PURDUE PHARMA drugs are available?

PURDUE PHARMA has nine approved drugs.

There are seventy-five US patents protecting PURDUE PHARMA drugs.

Summary for Purdue Pharma

US Patents:	75
Tradenames:	9
Ingredients:	9
NDAs:	9
Patent Litigation for Purdue Pharma:	See patent lawsuits for Purdue Pharma
PTAB Cases with Purdue Pharma as petitioner:	See PTAB cases with Purdue Pharma as petitioner
PTAB Cases with Purdue Pharma as patent owner:	See PTAB cases with Purdue Pharma as patent owner

Drugs and US Patents for Purdue Pharma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purdue Pharma Lp	HYSINGLA	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-006	Nov 20, 2014		RX	Yes	No	8,551,520		Y
Purdue Pharma Lp	HYSINGLA	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014		RX	Yes	No	9,770,416		Y
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014		DISCN	Yes	No	9,345,701		Y
Purdue Pharma Lp	HYSINGLA	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014		RX	Yes	No	8,551,520		Y
Purdue Pharma Lp	HYSINGLA	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014		RX	Yes	No	9,095,615		Y

Expired US Patents for Purdue Pharma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-005	Jun 30, 2014	6,344,211
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-005	Jun 30, 2014	RE41408
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-001	Sep 24, 2004	6,706,281
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-001	Jun 30, 2010	5,968,547
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-003	Jun 30, 2010	6,344,211

Paragraph IV (Patent) Challenges for PURDUE PHARMA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	100 mg, 200 mg and 300 mg		2009-06-18
	Transdermal System	5 mcg/hr, 10 mcg/hr, and 20 mcg/hr		2013-06-06
	Extended-release Tablets	15 mg		2007-02-15
	Sublingual Tablets	1.75 mg and 3.5 mg		2012-04-10
	Transdermal System	15 mcg/hr		2013-12-16
	Extended-release Tablets	30 mg and 60 mg		2007-01-03

Non-Orange Book US Patents for Purdue Pharma

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,480,685	Abuse-resistant controlled-release opioid dosage form
7,514,100	Controlled release hydrocodone formulations
2,010,151,022
9,511,065	Pharmaceutical formulation containing irritant
8,999,961	Pharmaceutical formulation containing gelling agent

International Patents for Purdue Pharma Drugs

Country	Document Number	Estimated Expiration
China	102813654
Israel	240000
Brazil	PI0413361
Spain	2374717
New Zealand	548856

Supplementary Protection Certificates for Purdue Pharma Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2015000006	Germany		PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
0714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2015 00004	Denmark		PRODUCT NAME: ZOLPIDEM OG FARMACEUTISK ACCEPTABLE SALTE HERAF, HERUNDER ZOLPIDEMTARTRAT; NAT. REG. NO/DATE: 47607 OG 47608 20120719; FIRST REG. NO/DATE: (B BE424286 OG BE424295 20120718
292	Luxembourg		PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
00714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Purdue Frederick
• Purdue Gmp
• Purdue Pharma
• Purdue Pharma Lp