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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Argus Health
Express Scripts
Farmers Insurance
Moodys
Chinese Patent Office
Healthtrust
AstraZeneca
Teva

Generated: September 20, 2018

DrugPatentWatch Database Preview

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.

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 ➤ Try a Free Trial Y ➤ Try a Free Trial
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 RX Yes No 9,770,416 ➤ Try a Free Trial Y ➤ Try a Free Trial
Purdue Pharma Lp TARGINIQ naloxone hydrochloride; oxycodone hydrochloride TABLET, EXTENDED RELEASE;ORAL 205777-003 Jul 23, 2014 DISCN Yes No 9,345,701 ➤ Try a Free Trial Y ➤ Try a Free Trial
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-004 Nov 20, 2014 RX Yes No 8,551,520 ➤ Try a Free Trial Y ➤ Try a Free Trial
Purdue Pharma Lp HYSINGLA hydrocodone bitartrate TABLET, EXTENDED RELEASE;ORAL 206627-007 Nov 20, 2014 RX Yes No 9,095,615 ➤ Try a Free Trial Y ➤ Try a Free 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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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 ➤ Try a Free Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-005 Jun 30, 2014 RE41408 ➤ Try a Free Trial
Purdue Pharma Lp PALLADONE hydromorphone hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 021044-001 Sep 24, 2004 6,706,281 ➤ Try a Free Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-001 Jun 30, 2010 5,968,547 ➤ Try a Free Trial
Purdue Pharma Lp BUTRANS buprenorphine FILM, EXTENDED RELEASE;TRANSDERMAL 021306-003 Jun 30, 2010 6,344,211 ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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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 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 and 60 mg ➤ Subscribe 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 ➤ Try a Free Trial
7,514,100 Controlled release hydrocodone formulations ➤ Try a Free Trial
2,010,151,022 ➤ Try a Free Trial
9,511,065 Pharmaceutical formulation containing irritant ➤ Try a Free Trial
8,999,961 Pharmaceutical formulation containing gelling agent ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Purdue Pharma Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2015000006 Germany ➤ Try a Free 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
0714 Netherlands ➤ Try a Free Trial 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 ➤ Try a Free 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
292 Luxembourg ➤ Try a Free 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
00714 Netherlands ➤ Try a Free Trial PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
McKesson
Merck
Express Scripts
Deloitte
Teva
AstraZeneca
US Army
Medtronic

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