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Last Updated: April 19, 2024

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 206627-001 Nov 20, 2014 AB RX Yes Yes 9,775,809 ⤷  Try a Trial Y ⤷  Try a Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014 AB RX Yes No 9,486,413 ⤷  Try a Trial Y ⤷  Try a Trial
Purdue Pharma INTERMEZZO zolpidem tartrate TABLET;SUBLINGUAL 022328-002 Nov 23, 2011 DISCN Yes No 8,252,809 ⤷  Try a Trial Y ⤷  Try a Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 AB RX Yes No 9,486,412 ⤷  Try a Trial Y ⤷  Try a Trial
Purdue Pharma Lp ADHANSIA XR methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 212038-004 Feb 27, 2019 DISCN Yes No 10,507,186 ⤷  Try a Trial Y ⤷  Try a 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 HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-002 Nov 20, 2014 9,056,052 ⤷  Try a Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010 RE41571 ⤷  Try a Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-005 Nov 20, 2014 9,669,023 ⤷  Try a Trial
Purdue Pharma Lp HYSINGLA ER hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-001 Nov 20, 2014 9,675,611 ⤷  Try a Trial
Purdue Pharma RYZOLT tramadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 021745-001 Dec 30, 2008 6,607,748 ⤷  Try a 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
0566709 SPC/GB04/012 United Kingdom ⤷  Try a Trial PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
1685839 92292 Luxembourg ⤷  Try a 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
2236132 CA 2015 00004 Denmark ⤷  Try a 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 92636 Luxembourg ⤷  Try a Trial PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2236132 122015000006 Germany ⤷  Try a 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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