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Generated: July 24, 2017
What is the competitive landscape for PURDUE PHARMA, and what generic alternatives to PURDUE PHARMA drugs are available?
PURDUE PHARMA has nine approved drugs.| 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;ORAL | 206627-002 | Nov 20, 2014 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Purdue Pharma Lp | HYSINGLA | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-004 | Nov 20, 2014 | RX | Yes | No | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Purdue Pharma Lp | HYSINGLA | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-006 | Nov 20, 2014 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Purdue Pharma Lp | HYSINGLA | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-001 | Nov 20, 2014 | RX | Yes | Yes | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
Purdue Pharma Lp | HYSINGLA | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-007 | Nov 20, 2014 | RX | Yes | No | ► Subscribe | ► Subscribe | Y | ► Subscribe | |||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-001 | Apr 5, 2010 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Purdue Pharma Lp | PALLADONE | hydromorphone hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021044-001 | Sep 24, 2004 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Purdue Pharma Lp | BUTRANS | buprenorphine | FILM, EXTENDED RELEASE;TRANSDERMAL | 021306-002 | Jun 30, 2010 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Purdue Pharma Lp | HYSINGLA | hydrocodone bitartrate | TABLET, EXTENDED RELEASE;ORAL | 206627-003 | Nov 20, 2014 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Purdue Pharma Lp | OXYCONTIN | oxycodone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 022272-004 | Apr 5, 2010 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
buprenorphine | Transdermal System | 15 mcg/hr | BUTRANS | 12/16/2013 |
buprenorphine | Transdermal System | 5 mcg/hr, 10 mcg/hr, and 20 mcg/hr | BUTRANS | 6/6/2013 |
zolpidem tartrate | Sublingual Tablets | 1.75 mg and 3.5 mg | INTERMEZZO | 4/10/2012 |
tramadol hydrochloride | Extended-release Tablets | 100 mg, 200 mg and 300 mg | RYZOLT | 6/18/2009 |
oxycodone hydrochloride | Extended-release Tablets | 15 mg | OXYCONTIN | 2/15/2007 |
oxycodone hydrochloride | Extended-release Tablets | 30 mg and 60 mg | OXYCONTIN | 1/3/2007 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,097,431 | Methods and compositions for detecting steroids | ► Subscribe | |||||||||||||||||||||||||||
| 8,323,889 | Process for the production of an abuse-proofed solid dosage form | ► Subscribe | |||||||||||||||||||||||||||
| 8,337,888 | Pharmaceutical formulation containing gelling agent | ► Subscribe | |||||||||||||||||||||||||||
| 8,999,961 | Pharmaceutical formulation containing gelling agent | ► Subscribe | |||||||||||||||||||||||||||
| 7,129,248 | Process 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tunisia | 2009000059 | ► Subscribe | |||||||||||||||||||||||||||
| Malaysia | 146650 | ► Subscribe | |||||||||||||||||||||||||||
| Japan | 5064209 | ► Subscribe | |||||||||||||||||||||||||||
| African Regional IP Organization (ARIPO) | 2355 | ► Subscribe | |||||||||||||||||||||||||||
| European Patent Office | 2292229 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 00714 | Netherlands | ► Subscribe | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NAT. REGISTRATION NO/DATE: RVG 108438 - 439 20130624; FIRST REGISTRATION: BE424286BE424295 2012180718 | ||||||||||||||||||||||||||
| 2015000006 | Germany | ► Subscribe | 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 | ||||||||||||||||||||||||||
| 636 | Luxembourg | ► Subscribe | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES | ||||||||||||||||||||||||||
| 00619 | Netherlands | ► Subscribe | PRODUCT 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 00052 | Denmark | ► Subscribe | PRODUCT 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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Serving 500+ biopharmaceutical companies globally:
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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