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Serving leading biopharmaceutical companies globally:

Citi
Johnson and Johnson
US Department of Justice
Cerilliant
Fuji
Express Scripts
Dow
Cipla
Fish and Richardson
Covington

Generated: December 11, 2017

DrugPatentWatch Database Preview

Celgene Company Profile

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What is the competitive landscape for CELGENE, and what generic alternatives to CELGENE drugs are available?

CELGENE has seven approved drugs.

There are fifty-four US patents protecting CELGENE drugs and there have been two Paragraph IV challenges on CELGENE drugs in the past three years.

There are six hundred and seventy-four patent family members on CELGENE drugs in fifty countries and twenty supplementary protection certificates in twelve countries.

Summary for Celgene

International Patents:674
US Patents:54
Tradenames:7
Ingredients:7
NDAs:7
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-003Jun 29, 2006RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
CelgeneTHALOMIDthalidomideCAPSULE;ORAL020785-002Jan 17, 2003RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-006Jun 5, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CelgenePOMALYSTpomalidomideCAPSULE;ORAL204026-001Feb 8, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CelgeneTHALOMIDthalidomideCAPSULE;ORAL020785-001Jul 16, 1998RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-005Dec 21, 2011RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-004Jun 29, 2006RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-001Dec 27, 2005RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-006Jun 5, 2013RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-002Dec 27, 2005RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Celgene

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-004Jun 29, 2006► Subscribe► Subscribe
CelgeneTHALOMIDthalidomideCAPSULE;ORAL020785-004Jan 10, 2007► Subscribe► Subscribe
CelgeneTHALOMIDthalidomideCAPSULE;ORAL020785-002Jan 17, 2003► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-001Dec 27, 2005► Subscribe► Subscribe
CelgenePOMALYSTpomalidomideCAPSULE;ORAL204026-003Feb 8, 2013► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-003Jun 29, 2006► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-004Jun 29, 2006► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-003Jun 29, 2006► Subscribe► Subscribe
CelgeneREVLIMIDlenalidomideCAPSULE;ORAL021880-005Dec 21, 2011► Subscribe► Subscribe
CelgeneTHALOMIDthalidomideCAPSULE;ORAL020785-003Jan 17, 2003► Subscribe► Subscribe
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Paragraph IV activity for CELGENE drugs

Drugname Dosage Strength Tradename Submissiondate
pomalidomideCapsules1 mg, 2 mg, 3 mg and 4 mgPOMALYST2/8/2017
lenalidomideCapsules2.5 mg and 20 mgREVLIMID7/12/2016
thalidomideCapsules150 mgTHALOMID2/3/2014
romidepsinInjection10 mg/vialISTODAX11/5/2013
lenalidomideCapsules5 mg, 10 mg and 15 mgREVLIMID8/30/2010
lenalidomideCapsules25 mgREVLIMID7/12/2010
thalidomideCapsules50 mg and 100 mgTHALOMID12/18/2006
thalidomideCapsules200 mgTHALOMID9/25/2006

Non-Orange Book Patents for Celgene

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
7,709,502Substituted 2-(2,6-dioxopiperidin-3-yl)-phthalimides and 1-oxoisoindolines► Subscribe
8,722,705Methods for treating diffuse large B-cell lymphoma with 3-(4-amino-1-OXO-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with second active agents► Subscribe
9,365,538Polymorphic forms of 3-(4-amino-1-oxo-1,3 dihydro-isoindol-2-yl)-piperidine-2,6-dione► Subscribe
9,433,606Solid forms comprising (+)-2-[1-(3-ethoxy-4-methoxyphenyl)-2-methylsulfonylethyl]-4-acetylaminoi- soindoline-1,3-dione, compositions thereof, and uses thereof► Subscribe
9,056,103Methods using 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione for treatment of certain leukemias► Subscribe
9,662,321Methods for treating newly diagnosed multiple myeloma with 3-(4-amino-1-OXO-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with second active agents► Subscribe
7,507,759Methods of using(+)-2-[1-(3-ethoxy-4methoxyphenyl)-2-methylsulfonylethyl]-- 4-acetylaminoisoindoline-1,3,-dione► Subscribe
9,050,324Methods for treating amyloidosis with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione► Subscribe
8,632,787Methods using immunomodulatory compounds for treatment of certain leukemias► Subscribe
9,155,730Methods for treating non-hodgkin's lymphoma with 3-(4-amino-1-oxo-1,3-dihydroisoindol-2-yl)-piperidine-2,6-dione in combination with a second active agent► 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 Celgene Drugs

Country Document Number Estimated Expiration
South Korea20120024938► Subscribe
World Intellectual Property Organization (WIPO)2004035064► Subscribe
Hong Kong1104968► Subscribe
Israel225792► Subscribe
China101683334► Subscribe
Norway20111536► Subscribe
Russian Federation2010137395► Subscribe
South Korea100793564► Subscribe
European Patent Office1752148► Subscribe
Hong Kong1203942► 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 Celgene Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0717Netherlands► SubscribePRODUCT NAME: POMALIDOMIDE EN FARMACEUTISCH AANVAARDBARE ZOUTEN, SOLVATEN, HYDRATEN OF STEREOISOMEREN DAARVAN; REGISTRATION NO/DATE: EU/1/13/850 20130805
2 50002-2015Slovakia► SubscribePRODUCT NAME: POMALIDOMID; REGISTRATION NO/DATE: EU/1/13/850/001 - EU/1/13/850/004 20130808
359Luxembourg► Subscribe91359, EXPIRES: 20220614
2015 00006Denmark► SubscribePRODUCT NAME: POMALIDOMID OG FARMACEUTISK ACCEPTABLE SALTE, SOLVATER, HYDRATER ELLER STEREOISOMERER HERAF; REG. NO/DATE: EU/1/13/850 20130805
2015000013Germany► SubscribePRODUCT NAME: POMALIDOMID UND SEINE PHARMAZEUTISCH AKZEPTABLEN SALZE, SOLVATE, HYDRATE ODER STEREOISOMERE (IMNOVID); REGISTRATION NO/DATE: EU/1/13/850 20130805
0150005 00140Estonia► SubscribePRODUCT NAME: POMALIDOMIID;REG NO/DATE: EU/1/13/850 08.08.2013
00358Netherlands► SubscribePRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
140Estonia► Subscribe
0925294/01Switzerland► SubscribePRODUCT NAME: LENALIDOMIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 57712 29.08.2007
C0036France► SubscribePRODUCT NAME: THALIDOMIDE; REGISTRATION NO/DATE: EU/1/08/443/001 20080416
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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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Serving leading biopharmaceutical companies globally:

US Department of Justice
Baxter
Moodys
Boehringer Ingelheim
Citi
Medtronic
Dow
Johnson and Johnson
Chinese Patent Office
Harvard Business School

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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