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Serving leading biopharmaceutical companies globally:

AstraZeneca
Citi
Colorcon
Queensland Health
Harvard Business School
Healthtrust
Chubb
Federal Trade Commission
Cerilliant
Farmers Insurance

Generated: December 17, 2017

DrugPatentWatch Database Preview

Merck Sharp Dohme Company Profile

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What is the competitive landscape for MERCK SHARP DOHME, and when can generic versions of MERCK SHARP DOHME drugs launch?

MERCK SHARP DOHME has forty-seven approved drugs.

There are fifty-six US patents protecting MERCK SHARP DOHME drugs on MERCK SHARP DOHME drugs in the past three years.

There are one thousand and fifty-two patent family members on MERCK SHARP DOHME drugs in sixty-nine countries and one hundred and ninety-two supplementary protection certificates in fifteen countries.

Summary for Merck Sharp Dohme

International Patents:1052
US Patents:56
Tradenames:37
Ingredients:29
NDAs:47
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck Sharp DohmeJANUMET XRmetformin hydrochloride; sitagliptin phosphateTABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 2012RXYesNo► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeJUVISYNCsimvastatin; sitagliptin phosphateTABLET;ORAL202343-002Oct 7, 2011DISCNYesNo► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeJANUVIAsitagliptin phosphateTABLET;ORAL021995-001Oct 16, 2006RXYesNo► Subscribe► Subscribe► Subscribe
Merck Sharp DohmeASMANEX TWISTHALERmometasone furoatePOWDER;INHALATION021067-001Mar 30, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeTEMODARtemozolomidePOWDER;INTRAVENOUS022277-001Feb 27, 2009RXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeCLARINEX-D 12 HOURdesloratadine; pseudoephedrine sulfateTABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006RXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeISENTRESS HDraltegravir potassiumTABLET;ORAL022145-002May 26, 2017RXYesNo► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeJANUMET XRmetformin hydrochloride; sitagliptin phosphateTABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeASMANEX TWISTHALERmometasone furoatePOWDER;INHALATION021067-002Feb 1, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Merck Sharp DohmeJANUMET XRmetformin hydrochloride; sitagliptin phosphateTABLET, EXTENDED RELEASE;ORAL202270-002Feb 2, 2012RXYesNo► Subscribe► SubscribeY► Subscribe
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Expired Patents for Merck Sharp Dohme

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp DohmeCLARINEXdesloratadineTABLET, ORALLY DISINTEGRATING;ORAL021312-001Jun 26, 2002► Subscribe► Subscribe
Merck Sharp DohmeLIPTRUZETatorvastatin calcium; ezetimibeTABLET;ORAL200153-001May 3, 2013► Subscribe► Subscribe
Merck Sharp DohmeJANUMET XRmetformin hydrochloride; sitagliptin phosphateTABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 2012► Subscribe► Subscribe
Merck Sharp DohmeCLARINEX-D 12 HOURdesloratadine; pseudoephedrine sulfateTABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006► Subscribe► Subscribe
Merck Sharp DohmeSINEMETcarbidopa; levodopaTABLET;ORAL017555-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Merck Sharp DohmeCLARINEX-D 12 HOURdesloratadine; pseudoephedrine sulfateTABLET, EXTENDED RELEASE;ORAL021313-001Feb 1, 2006► Subscribe► Subscribe
Merck Sharp DohmeASMANEX TWISTHALERmometasone furoatePOWDER;INHALATION021067-001Mar 30, 2005► Subscribe► Subscribe
Merck Sharp DohmeASMANEX HFAmometasone furoateAEROSOL, METERED;INHALATION205641-002Apr 25, 2014► Subscribe► Subscribe
Merck Sharp DohmeLIPTRUZETatorvastatin calcium; ezetimibeTABLET;ORAL200153-001May 3, 2013► Subscribe► Subscribe
Merck Sharp DohmeHYZAARhydrochlorothiazide; losartan potassiumTABLET;ORAL020387-001Apr 28, 1995► Subscribe► Subscribe
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Paragraph IV activity for MERCK SHARP DOHME drugs

Drugname Dosage Strength Tradename Submissiondate
posaconazoleInjection18 mg/mL, 16.7 mL vialsNOXAFIL11/24/2015
posaconazoleDelayed-release Tablets100 mgNOXAFIL6/16/2014
ertapenemInjection1 g/vialINVANZ6/20/2013
sitagliptin phosphate and simvastatinTablets50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mgJUVISYNC11/6/2012
sitagliptin phosphate and metformin hydrochlorideExtended-release Tablets100 mg/1000 mgJANUMET XR10/22/2012
sitagliptin and simvastatin phosphateTablets100 mg/10 mg and 100 mg/40 mgJUVISYNC6/25/2012
sitagliptin and simvastatin phosphateTablets100 mg/10 mg and 100 mg/40 mgJUVISYNC6/19/2012
sitagliptin phosphate and metformin hydrochlorideExtended-release Capsules50 mg/500 mg and 50 mg/1000 mgJANUMET XR3/16/2012
raltegravirTablets400 mgISENTRESS10/12/2011
posaconazoleOral Suspension40 mg/mLNOXAFIL2/28/2011
sitagliptin phosphateTablets25 mg, 50 mg and 100 mgJANUVIA10/18/2010
sitagliptin phosphate and metformin hydrochlorideTablets50 mg/500 mg and 50 mg/1000 mgJANUMET10/18/2010
mometasone furoateNasal Spray50 mcg/ SprayNASONEX8/7/2009
temozolomideCapsules140 mg and 180 mgTEMODAR3/24/2008
desloratadineTablets5 mgCLARINEX6/21/2006
desloratadineOrally Disintegrating Tablets2.5 mg and 5 mgCLARINEX6/21/2006
losartan potassium and hydrochlorothiazideTablets100 mg/12.5 mLHYZAAR4/4/2006
mometasone furoateTopical Solution (Lotion)0.10%ELOCON6/10/2004
losartan potassium and hydrochlorothiazideTablets50 mg/12.5 mg and 100 mg/25 mgHYZAAR5/24/2004

Premature patent expirations for MERCK SHARP DOHME

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
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Non-Orange Book Patents for Merck Sharp Dohme

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
8,076,335Processes of making pharmaceutical formulations of antineoplastic agents► Subscribe
9,044,424Methods of regulating glucose metabolism, and reagents related thereto► Subscribe
7,387,794Preparation of powder agglomerate► Subscribe
7,592,316Peptides as NS3-serine protease inhibitors of hepatitis C virus► Subscribe
8,080,654Macrocyclic quinoxaline compounds as HCV NS3 protease inhibitors► Subscribe
8,318,669Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,357,798Process for preparing N-alkylated hydroxypyrimidinone compounds► Subscribe
6,803,357 Method of regulating glucose metabolism, and reagents related thereto► Subscribe
5,693,626 Tetrahydrofuran antifungals► Subscribe
7,687,073Preparation of powder agglomerates► 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 Merck Sharp Dohme Drugs

Country Document Number Estimated Expiration
Japan2005015485► Subscribe
Hong Kong1219883► Subscribe
Slovakia19672000► Subscribe
Indonesia16974► Subscribe
Slovakia288064► Subscribe
Slovakia287878► Subscribe
Japan4705956► Subscribe
Iceland2436► Subscribe
Japan2002538110► Subscribe
New Zealand523782► 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 Merck Sharp Dohme Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00064Denmark► SubscribePRODUCT NAME: VILDAGLIPTIN; REG. NO/DATE: EU/1/07/414/001-017 20070928
2014 00063Denmark► SubscribePRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070321
2016048Lithuania► SubscribePRODUCT NAME: ELBASVIRAS ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS; NAT. REGISTRATION NO/DATE: CH/65861 01 20160401; FIRST REGISTRATION: EU/1/16/1119 20160722
428Luxembourg► Subscribe91428, EXPIRES: 20230102
2008007,C1441735Lithuania► SubscribePRODUCT NAME: RALTEGRAVIRUM; REGISTRATION NO/DATE: EU/1/07/436/001, 2007 12 20 EU/1/07/436/002 20071220
0160050 00207Estonia► SubscribePRODUCT NAME: ELBASVIIR;REG NO/DATE: EU/1/16/1119 26.07.2016
C0048France► SubscribePRODUCT NAME: AMLODIPINE OU UN DE SES SELS D?ADDITION D?ACIDES PHARMACAUTIQUEMENT ACCEPTABLES/ ATORVASTATINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: NL 29929 DU 20050707; REGISTRATION NO/DATE AT EEC: NL 29929 DU 20050707
C0041France► SubscribePRODUCT NAME: ERTAPENEM SODIUM; REGISTRATION NO/DATE: EU/1/02/216/001 20020418
0308Netherlands► Subscribe300308, 20170424, EXPIRES: 20220423
8Finland► Subscribe
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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 plans and pricing

Serving leading biopharmaceutical companies globally:

Baxter
Novartis
Daiichi Sankyo
Medtronic
Express Scripts
Covington
Teva
Cipla
Dow
Farmers Insurance

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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