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Serving leading biopharmaceutical companies globally:

Express Scripts
Chubb
Covington
Fish and Richardson
Farmers Insurance
Medtronic
Deloitte
Accenture
Argus Health
McKinsey

Generated: October 20, 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-eight patent family members on MERCK SHARP DOHME drugs in sixty-nine countries and one hundred and eighty-nine supplementary protection certificates in fifteen countries.

Summary for Applicant: Merck Sharp Dohme

International Patents:1058
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 Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-003Oct 7, 2011DISCNYesNo► Subscribe► SubscribeYY ► Subscribe
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 2005ABRXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-002Oct 7, 2011DISCNYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
POWDER;ORAL205786-001Dec 20, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
BELSOMRA
suvorexant
TABLET;ORAL204569-002Aug 13, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
DIPROLENE AF
betamethasone dipropionate
CREAM, AUGMENTED;TOPICAL019555-001Apr 27, 1987ABRXYesYes► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
BELSOMRA
suvorexant
TABLET;ORAL204569-003Aug 13, 2014RXYesNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Merck Sharp Dohme
ASMANEX HFA
mometasone furoate
AEROSOL, METERED;INHALATION205641-002Apr 25, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-002Oct 7, 2011DISCNYesNo► Subscribe► Subscribe ► 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 Dohme
LOTRISONE
betamethasone dipropionate; clotrimazole
CREAM;TOPICAL018827-001Jul 10, 1984► Subscribe► Subscribe
Merck Sharp Dohme
HYZAAR
hydrochlorothiazide; losartan potassium
TABLET;ORAL020387-002Nov 10, 1998► Subscribe► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-001Oct 16, 2006► Subscribe► Subscribe
Merck Sharp Dohme
CRIXIVAN
indinavir sulfate
CAPSULE;ORAL020685-003Mar 13, 1996► Subscribe► Subscribe
Merck Sharp Dohme
INVANZ
ertapenem sodium
INJECTABLE;INTRAMUSCULAR, IV (INFUSION)021337-001Nov 21, 2001► Subscribe► Subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
TABLET, ORALLY DISINTEGRATING;ORAL021312-002Jul 14, 2005► Subscribe► Subscribe
Merck Sharp Dohme
CELESTONE SOLUSPAN
betamethasone acetate; betamethasone sodium phosphate
INJECTABLE;INJECTION014602-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Merck Sharp Dohme
COZAAR
losartan potassium
TABLET;ORAL020386-002Apr 14, 1995► Subscribe► Subscribe
Merck Sharp Dohme
DIPROLENE
betamethasone dipropionate
LOTION, AUGMENTED;TOPICAL019716-001Aug 1, 1988► Subscribe► Subscribe
Merck Sharp Dohme
SINEMET
carbidopa; levodopa
TABLET;ORAL017555-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Paragraph IV activity for MERCK SHARP DOHME drugs

Drugname Dosage Strength Tradename Submissiondate
posaconazole
Injection18 mg/mL, 16.7 mL vials
NOXAFIL
11/24/2015
posaconazole
Delayed-release Tablets100 mg
NOXAFIL
6/16/2014
ertapenem
Injection1 g/vial
INVANZ
6/20/2013
sitagliptin phosphate and simvastatin
Tablets50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mg
JUVISYNC
11/6/2012
sitagliptin phosphate and metformin hydrochloride
Extended-release Tablets100 mg/1000 mg
JANUMET XR
10/22/2012
sitagliptin and simvastatin phosphate
Tablets100 mg/10 mg and 100 mg/40 mg
JUVISYNC
6/25/2012
sitagliptin and simvastatin phosphate
Tablets100 mg/10 mg and 100 mg/40 mg
JUVISYNC
6/19/2012
sitagliptin phosphate and metformin hydrochloride
Extended-release Capsules50 mg/500 mg and 50 mg/1000 mg
JANUMET XR
3/16/2012
raltegravir
Tablets400 mg
ISENTRESS
10/12/2011
posaconazole
Oral Suspension40 mg/mL
NOXAFIL
2/28/2011
sitagliptin phosphate
Tablets25 mg, 50 mg and 100 mg
JANUVIA
10/18/2010
sitagliptin phosphate and metformin hydrochloride
Tablets50 mg/500 mg and 50 mg/1000 mg
JANUMET
10/18/2010
mometasone furoate
Nasal Spray50 mcg/ Spray
NASONEX
8/7/2009
temozolomide
Capsules140 mg and 180 mg
TEMODAR
3/24/2008
desloratadine
Tablets5 mg
CLARINEX
6/21/2006
desloratadine
Orally Disintegrating Tablets2.5 mg and 5 mg
CLARINEX
6/21/2006
losartan potassium and hydrochlorothiazide
Tablets100 mg/12.5 mL
HYZAAR
4/4/2006
mometasone furoate
Topical Solution (Lotion)0.10%
ELOCON
6/10/2004
losartan potassium and hydrochlorothiazide
Tablets50 mg/12.5 mg and 100 mg/25 mg
HYZAAR
5/24/2004

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
5,714,490 Tetrahydrofuran antifungals► Subscribe
9,044,424Methods of regulating glucose metabolism, and reagents related thereto► Subscribe
8,318,669Method of regulating glucose metabolism, and reagents related thereto► Subscribe
7,157,429Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,076,335Processes of making pharmaceutical formulations of antineoplastic agents► Subscribe
5,693,626 Tetrahydrofuran antifungals► Subscribe
7,635,773Sulfoalkyl ether cyclodextrin compositions► Subscribe
7,687,073Preparation of powder agglomerates► Subscribe
7,829,530Method of regulating glucose metabolism, and reagents related thereto► Subscribe
7,592,316Peptides as NS3-serine protease inhibitors of hepatitis C virus► 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
Hungary0401740► Subscribe
Brazil0307802► Subscribe
Argentina027034► Subscribe
Luxembourg91382► Subscribe
Germany122008000001► Subscribe
Japan2009051860► Subscribe
MexicoPA00012957► Subscribe
Poland188917► Subscribe
Denmark1110543► Subscribe
Portugal1819700► 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
1084705/05Switzerland► SubscribePRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: SWISSMEDIC 62955 21.11.2013
00095Netherlands► SubscribePRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
00709Netherlands► SubscribePRODUCT NAME: ALOGLIPTIN; REGISTRATION NO/DATE: EU/1/13/844/001-027 20130919
0160050 00207Estonia► SubscribePRODUCT NAME: ELBASVIIR;REG NO/DATE: EU/1/16/1119 26.07.2016
2014043Lithuania► SubscribePRODUCT NAME: SAXAGLIPTINUM; REGISTRATION NO/DATE: EU/1/09/545/001-015 20091001
2008 00021Denmark► Subscribe
2007 00030Denmark► Subscribe
382Luxembourg► Subscribe91382, EXPIRES: 20220424
C/GB05/010United Kingdom► SubscribePRODUCT NAME: EZETIMIBE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH SIMVASTATIN; REGISTERED: DE 58874.00.00 20040402; DE 58874.01.00 20040402; DE 58874.02.00 20040402; DE 58874.03.00 20040402; DE 58878.00.00 20040402; DE 58878.01.00 20040402; DE 58878.02.00 20040402; DE 58878.03.00 20040402; DE 58866.00.00 20040402; DE 58866.01.00 20040402; DE 58866.02.00 20040402; DE 58866.03.00 20040402; DE 58870.00.00 20040402; DE 58870.01.00 20040402; DE 58870.02.00 20040402; DE 58870.03.00 20040402; UK PL 19945/0003 20041118; UK PL 19945/0004 20041118; UK PL 19945/0005 20041118; UK PL 19945/0006 20041118; UK PL 19945/0007 20041118; UK PL 19945/0008 20041118; UK PL 19945/0009 200411
2014044Lithuania► SubscribePRODUCT NAME: LINAGLIPTINUM; REGISTRATION NO/DATE: EU/1/11/707/001-011 20110824
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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 leading biopharmaceutical companies globally:

Teva
Deloitte
QuintilesIMS
Healthtrust
UBS
McKinsey
Cipla
Express Scripts
Fuji
Federal Trade Commission

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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