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Purdue Pharma Company Profile

PURDUE PHARMA has ten approved drugs.

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

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

International Patents:	934
US Patents:	85
Tradenames:	10
Ingredients:	10
NDAs:	10
Patent Litigation for Purdue Pharma:	See patent lawsuits for Purdue Pharma
PTAB Cases with Purdue Pharma as patent owner:	See PTAB cases with Purdue Pharma as patent owner

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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
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-006	Apr 5, 2010		RX	Yes	No	10,675,278	Start Trial	Y			Start Trial
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014		RX	Yes	Yes	9,289,391	Start Trial	Y			Start Trial
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-004	Nov 20, 2014		RX	Yes	No	9,872,837	Start Trial	Y			Start Trial
Purdue Pharma Lp	ADHANSIA XR	methylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	212038-004	Feb 27, 2019		RX	Yes	No	10,111,839	Start Trial				Start Trial
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-001	Nov 20, 2014		RX	Yes	Yes	9,669,024	Start Trial	Y			Start Trial
Purdue Pharma Lp	OXYCONTIN	oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	022272-003	Apr 5, 2010		RX	Yes	No	8,309,060	Start Trial	Y			Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma Lp	BUTRANS	buprenorphine	FILM, EXTENDED RELEASE;TRANSDERMAL	021306-001	Jun 30, 2010	6,344,211	Start Trial
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-002	Sep 24, 2004	5,958,452	Start Trial
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-001	Jul 23, 2014	6,696,066	Start Trial
Purdue Pharma Lp	TARGINIQ	naloxone hydrochloride; oxycodone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	205777-002	Jul 23, 2014	6,277,384	Start Trial
Purdue Pharma Lp	PALLADONE	hydromorphone hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	021044-002	Sep 24, 2004	6,743,442	Start Trial
Purdue Pharma Lp	HYSINGLA ER	hydrocodone bitartrate	TABLET, EXTENDED RELEASE;ORAL	206627-002	Nov 20, 2014	6,488,963	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Sublingual Tablets	1.75 mg and 3.5 mg	➤ Subscribe	2012-04-10
➤ Subscribe	Transdermal System	15 mcg/hr	➤ Subscribe	2013-12-16
➤ Subscribe	Extended-release Tablets	30 mg, 40 mg, 80 mg, and 100 mg	➤ Subscribe	2015-05-08
➤ Subscribe	Extended-release Tablets	30 mg and 60 mg	➤ Subscribe	2007-01-03
➤ Subscribe	Extended-release Tablets	100 mg, 200 mg and 300 mg	➤ Subscribe	2009-06-18
➤ Subscribe	Transdermal System	5 mcg/hr, 10 mcg/hr, and 20 mcg/hr	➤ Subscribe	2013-06-06
➤ Subscribe	Extended-release Tablets	20 mg, 60 mg, and 120 mg	➤ Subscribe	2015-04-15
➤ Subscribe	Extended-release Tablets	15 mg	➤ Subscribe	2007-02-15

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Country	Patent Number	Estimated Expiration
Spain	2417335	Start Trial
World Intellectual Property Organization (WIPO)	2005016314	Start Trial
Finland	U20070322	Start Trial
South Korea	100840393	Start Trial
European Patent Office	2932964	Start Trial
Taiwan	I538699	Start Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0566709	SPC/GB04/012	United Kingdom	Start Trial	PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
2236132	C300714	Netherlands	Start Trial	PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2236132	CA 2015 00004	Denmark	Start Trial	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	122015000006	Germany	Start Trial	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
0566709	C300152	Netherlands	Start Trial	PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
1685839	92292	Luxembourg	Start Trial	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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