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Last Updated: October 19, 2019

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Purdue Pharma Company Profile

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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 ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014 RX Yes No 9,492,390   Start Trial   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-003 Nov 20, 2014 RX Yes No 10,369,109   Start Trial Y   Start Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-003 Apr 5, 2010 RX Yes No 9,763,933   Start Trial Y   Start Trial
Purdue Pharma Lp ADHANSIA XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212038-002 Feb 27, 2019 RX Yes No 10,111,839   Start Trial   Start Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-001 Apr 5, 2010 RX Yes No 10,130,591   Start Trial Y   Start Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014 RX Yes No 9,775,809   Start Trial Y   Start Trial
Purdue Pharma Lp ADHANSIA XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212038-004 Feb 27, 2019 RX Yes No 10,292,939   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

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 021306-002 Jun 30, 2010 6,344,211   Start Trial
Purdue Pharma Lp OXYCONTIN oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 022272-004 Apr 5, 2010 6,488,963   Start Trial
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-003 Sep 24, 2004 5,965,161   Start Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 RE41571   Start Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-002 Jun 30, 2010 5,240,711   Start Trial
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-002 Dec 30, 2008 5,591,452   Start Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 RE41408   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for PURDUE PHARMA drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ 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

Supplementary Protection Certificates for Purdue Pharma Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0566709 SPC/GB04/012 United Kingdom   Start Trial PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
2236132 92636 Luxembourg   Start Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
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
0566709 C300152 Netherlands   Start Trial PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
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
2236132 300714 Netherlands   Start Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
McKinsey
Colorcon
AstraZeneca
Express Scripts
Mallinckrodt

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