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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Fuji
Farmers Insurance
Novartis
Express Scripts
Mallinckrodt
Healthtrust
McKinsey
Johnson and Johnson
Moodys

Generated: July 24, 2017

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-one US patents protecting PURDUE PHARMA drugs.

There are eight hundred and ninety-three patent family members on PURDUE PHARMA drugs in fifty-three countries.

Summary for Applicant: Purdue Pharma

Patents:71
Tradenames:9
Ingredients:9
NDAs:9
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;ORAL206627-002Nov 20, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-004Nov 20, 2014RXYesNo► Subscribe► Subscribe ► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-006Nov 20, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-001Nov 20, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-007Nov 20, 2014RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Purdue Pharma

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-001Apr 5, 2010► Subscribe► Subscribe
Purdue Pharma Lp
PALLADONE
hydromorphone hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021044-001Sep 24, 2004► Subscribe► Subscribe
Purdue Pharma Lp
BUTRANS
buprenorphine
FILM, EXTENDED RELEASE;TRANSDERMAL021306-002Jun 30, 2010► Subscribe► Subscribe
Purdue Pharma Lp
HYSINGLA
hydrocodone bitartrate
TABLET, EXTENDED RELEASE;ORAL206627-003Nov 20, 2014► Subscribe► Subscribe
Purdue Pharma Lp
OXYCONTIN
oxycodone hydrochloride
TABLET, EXTENDED RELEASE;ORAL022272-004Apr 5, 2010► Subscribe► Subscribe
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Paragraph IV activity for PURDUE PHARMA drugs

Drugname Dosage Strength Tradename Submissiondate
buprenorphine
Transdermal System15 mcg/hr
BUTRANS
12/16/2013
buprenorphine
Transdermal System5 mcg/hr, 10 mcg/hr, and 20 mcg/hr
BUTRANS
6/6/2013
zolpidem tartrate
Sublingual Tablets1.75 mg and 3.5 mg
INTERMEZZO
4/10/2012
tramadol hydrochloride
Extended-release Tablets100 mg, 200 mg and 300 mg
RYZOLT
6/18/2009
oxycodone hydrochloride
Extended-release Tablets15 mg
OXYCONTIN
2/15/2007
oxycodone hydrochloride
Extended-release Tablets30 mg and 60 mg
OXYCONTIN
1/3/2007

Non-Orange Book 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
8,097,431Methods and compositions for detecting steroids► Subscribe
8,323,889Process for the production of an abuse-proofed solid dosage form► Subscribe
8,337,888Pharmaceutical formulation containing gelling agent► Subscribe
8,999,961Pharmaceutical formulation containing gelling agent► Subscribe
7,129,248Process for preparing oxycodone hydrochloride having less than 25 ppm 14-hydroxycodeinone► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Purdue Pharma Drugs

Country Document Number Estimated Expiration
Tunisia2009000059► Subscribe
Malaysia146650► Subscribe
Japan5064209► Subscribe
African Regional IP Organization (ARIPO)2355► Subscribe
European Patent Office2292229► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Purdue Pharma Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00714Netherlands► SubscribePRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718
2015000006Germany► SubscribePRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718
636Luxembourg► SubscribePRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES
00619Netherlands► SubscribePRODUCT 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
2013 00052Denmark► SubscribePRODUCT NAME: KOMBINATION AF OXYCODON SOM KOMPONENT A OG NALOXON SOM KOMPONENT B, HERUNDER OXYCODONHYDROCHLORID OG NALOXONHYDROCHLORIDDIHYDRAT; NAT. REG. NO/DATE: 43673, 43674 20081117; FIRST REG. NO/DATE: DE 64537.00.00, 64538.00.00, 64540.00.00, 64541.00.00 20060530
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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

Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Johnson and Johnson
Moodys
Fuji
McKinsey
Julphar
Citi
Teva
Boehringer Ingelheim
Cerilliant

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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