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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-six US patents protecting PURDUE PHARMA drugs.

There are nine hundred and sixteen patent family members on PURDUE PHARMA drugs in fifty-four countries and eleven supplementary protection certificates in five countries.

Summary for Purdue Pharma

International Patents:	916
US Patents:	76
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	206627-002	Nov 20, 2014		RX	Yes	No	9,572,804		Y
Purdue Pharma Lp	HYSINGLA	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014		RX	Yes	No	9,486,413		Y
Purdue Pharma Lp	HYSINGLA	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014		RX	Yes	No	9,763,933		Y
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-007	Apr 5, 2010		RX	Yes	No	9,763,933		Y
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-004	Apr 5, 2010		RX	Yes	No	9,522,919		Y	Y
Purdue Pharma Lp	HYSINGLA	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-007	Nov 20, 2014		RX	Yes	No	9,750,703		Y

Expired US Patents for Purdue Pharma

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-004	Sep 24, 2004	5,958,452
Purdue Pharma Lp	HYSINGLA	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-003	Nov 20, 2014	6,488,963
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014	8,673,355
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-003	Jul 23, 2014	8,822,487
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-001	Jun 30, 2010	5,968,547
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-002	Apr 5, 2010	6,488,963

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

International Patents for Purdue Pharma Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	2314589
Australia	2003262463
Hong Kong	1072366
Austria	9952
Portugal	2070538
South Korea	101197919

Supplementary Protection Certificates for Purdue Pharma Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1685839	122013000082	Germany		PRODUCT NAME: KOMBINATION VON OXYCODON ALS KOMPONENTE A UND NALOXON ALS KOMPONENTE B IN ALLEN DEM SCHUTZ DES GRUNDPATENTS UNTERLIEGENDEN FORMEN; REGISTRATION NO/DATE: 64537.00.00 64538.00.00 64540.00.00 64541.00.00 73083.00.00 73084.00.00 73085.00.00 73086.00.00 20060530
1685839	C300619	Netherlands		PRODUCT NAME: EEN COMBINATIE VAN OXYCODON ALS COMPONENT A EN NALOXON ALS COMPONENT B IN ALLE VORMEN ZOALS DEZE DOOR HET BASIS OCTROOI ONDER BESCHERMING WORDEN GESTELD; REGISTRATION NO/DATE: 64537.00.00 64538.00.00 64540.00.00 64541.00.00 20060530
2236132	300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
2236132	CA 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
2236132	C300714	Netherlands		PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
0566709	SPC/GB04/012	United Kingdom		PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925

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