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Serving leading biopharmaceutical companies globally:

Teva
Fuji
Express Scripts
Chubb
Fish and Richardson
Novartis
Daiichi Sankyo
US Department of Justice
Colorcon
Accenture

Generated: November 22, 2017

DrugPatentWatch Database Preview

MERCK SHARP DOHME Company Profile

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

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 ninety-two supplementary protection certificates in fifteen countries.

Summary for 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
ISENTRESS
raltegravir potassium
TABLET, CHEWABLE;ORAL203045-001Dec 21, 2011RXYesNo► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 2012RXYesNo► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-002May 3, 2013DISCNYesNo► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
SINEMET CR
carbidopa; levodopa
TABLET, EXTENDED RELEASE;ORAL019856-001May 30, 1991ABRXYesYes► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
ASMANEX TWISTHALER
mometasone furoate
POWDER;INHALATION021067-002Feb 1, 2008RXYesNo► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
TEMODAR
temozolomide
POWDER;INTRAVENOUS022277-001Feb 27, 2009RXYesYes► Subscribe► SubscribeY ► Subscribe
Merck Sharp Dohme
REBETOL
ribavirin
CAPSULE;ORAL020903-002Jul 25, 2001ABRXYesYes► Subscribe► SubscribeY► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-002Feb 2, 2012RXYesNo► 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
HYZAAR
hydrochlorothiazide; losartan potassium
TABLET;ORAL020387-001Apr 28, 1995► Subscribe► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-001Oct 7, 2011► Subscribe► Subscribe
Merck Sharp Dohme
SINEMET
carbidopa; levodopa
TABLET;ORAL017555-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-001Feb 2, 2012► Subscribe► Subscribe
Merck Sharp Dohme
ASMANEX HFA
mometasone furoate
AEROSOL, METERED;INHALATION205641-002Apr 25, 2014► Subscribe► Subscribe
Merck Sharp Dohme
INVANZ
ertapenem sodium
INJECTABLE;INTRAMUSCULAR, IV (INFUSION)021337-001Nov 21, 2001► Subscribe► Subscribe
Merck Sharp Dohme
NASONEX
mometasone furoate
SPRAY, METERED;NASAL020762-001Oct 1, 1997► Subscribe► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-004May 3, 2013► Subscribe► Subscribe
Merck Sharp Dohme
ELOCON
mometasone furoate
LOTION;TOPICAL019796-001Mar 30, 1989► Subscribe► Subscribe
Merck Sharp Dohme
JANUMET XR
metformin hydrochloride; sitagliptin phosphate
TABLET, EXTENDED RELEASE;ORAL202270-003Feb 2, 2012► 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
9,200,088Sulfoalkyl ether cyclodextrin compositions► Subscribe
8,513,190Method of regulating glucose metabolism, and reagents related thereto► Subscribe
7,157,429Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,080,654Macrocyclic quinoxaline compounds as HCV NS3 protease inhibitors► Subscribe
9,090,661Inhibitors of hepatitis C virus replication► Subscribe
7,592,316Peptides as NS3-serine protease inhibitors of hepatitis C virus► Subscribe
6,803,357 Method of regulating glucose metabolism, and reagents related thereto► Subscribe
5,693,626 Tetrahydrofuran antifungals► Subscribe
5,710,154 Tetrahydrofuran antifungals► Subscribe
5,714,490 Tetrahydrofuran antifungals► 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
Hong Kong1173402► Subscribe
Norway20031574► Subscribe
Turkey9800146► Subscribe
Germany69616808► Subscribe
Hong Kong1211311► Subscribe
South Africa200405304► Subscribe
Japan5932929► Subscribe
Denmark2540350► Subscribe
World Intellectual Property Organization (WIPO)9938501► Subscribe
Portugal2089382► 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
0219Netherlands► Subscribe300219, 20141220, EXPIRES: 20191219
C/GB14/085United Kingdom► SubscribePRODUCT NAME: SAXAGLIPTIN; REGISTERED: UK EU/1/09/545/001-010 20091005
2008000046Germany► SubscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
1506211/02Switzerland► SubscribePRODUCT NAME: DAPAGLIFLOZIN + METFORMIN; REGISTRATION NO/DATE: SWISSMEDIC 65377 16.07.2015
50009Netherlands► SubscribePRODUCT NAME: LOSARTAN, DESGEWENST IN DE VORM VAN EEN AANVAARDBAAR ZOUT, IN HET BIJZONDER HET KALIUMZOUT; NAT. REGISTRATION NO/DATE: RVG 17617 19950314; FIRST REGISTRATION: SE 12209 19940902
128Luxembourg► SubscribePRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3, 7-DIHYDROPURIN-2, 6-DION, LES ENANTIOMERES ET LEURS SELS, EN PARTICULIER LA LINAGLIPTINE COMBINEE AVEC DU CHLORHYDRATE DE METFORMINE. LINAGLIPTINE
2016048Lithuania► SubscribePRODUCT NAME: ELBASVIRAS ARBA JO FARMACISKAI PRIIMTINOS DRUSKOS; NAT. REGISTRATION NO/DATE: CH/65861 01 20160401; FIRST REGISTRATION: EU/1/16/1119 20160722
/2008Austria► SubscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
0736030/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
2008 00010Denmark► 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 database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

UBS
Medtronic
Mallinckrodt
Baxter
Harvard Business School
QuintilesIMS
Johnson and Johnson
Cantor Fitzgerald
Dow
McKesson

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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