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Serving 500+ biopharmaceutical companies globally:

McKesson
Daiichi Sankyo
Accenture
Fuji
Medtronic
Citi
Boehringer Ingelheim
Express Scripts
Julphar
Mallinckrodt

Generated: July 28, 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 forty-seven patent family members on MERCK SHARP DOHME drugs in sixty-nine countries.

Summary for Applicant: MERCK SHARP DOHME

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
SINEMET
carbidopa; levodopa
TABLET;ORAL017555-003Approved Prior to Jan 1, 1982ABRXYesNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
JANUMET
metformin hydrochloride; sitagliptin phosphate
TABLET;ORAL022044-001Mar 30, 2007RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
ISENTRESS HD
raltegravir potassium
TABLET;ORAL022145-002May 26, 2017RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
SINEMET
carbidopa; levodopa
TABLET;ORAL017555-001Approved Prior to Jan 1, 1982ABRXYesNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
CRIXIVAN
indinavir sulfate
CAPSULE;ORAL020685-003Mar 13, 1996RXYesNo► 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
ASMANEX TWISTHALER
mometasone furoate
POWDER;INHALATION021067-002Feb 1, 2008► Subscribe► Subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
TABLET, ORALLY DISINTEGRATING;ORAL021312-001Jun 26, 2002► Subscribe► Subscribe
Merck Sharp Dohme
SINEMET CR
carbidopa; levodopa
TABLET, EXTENDED RELEASE;ORAL019856-001May 30, 1991► Subscribe► Subscribe
Merck Sharp Dohme
SINEMET
carbidopa; levodopa
TABLET;ORAL017555-003Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Merck Sharp Dohme
CLARINEX D 24 HOUR
desloratadine; pseudoephedrine sulfate
TABLET, EXTENDED RELEASE;ORAL021605-001Mar 3, 2005► 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
6,495,167 Preparation of powder agglomerates► Subscribe
7,157,429Method of regulating glucose metabolism, and reagents related thereto► Subscribe
8,440,668Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of type 2 diabetes► Subscribe
7,244,721Peptides as NS3-serine protease inhibitors of hepatitis C virus► Subscribe
7,674,790Processes of making and using pharmaceutical formulations of antineoplastic agents► 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
Canada2329172► Subscribe
Israel203847► Subscribe
TaiwanI428138► Subscribe
Japan5158919► Subscribe
Japan2016166368► 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
2014026,C1506211Lithuania► SubscribePRODUCT NAME: DAPAGLIFLOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
C0041France► SubscribePRODUCT NAME: SITAGLIPTINE, EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET EN PARTICULIER LE PHOSPHATE DE SITAGLIPTINE MONOHYDRATE; REGISTRATION NO/DATE: EU/1/07/383/001 20070323
0160050 00207Estonia► SubscribePRODUCT NAME: ELBASVIIR;REG NO/DATE: EU/1/16/1119 26.07.2016
0160050Estonia► Subscribe(93) SZ 65861 01, 01.04.2016 (93) CH 65861 01, 01.04.2016
00756Netherlands► SubscribePRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN; NAT. REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MA117/01101 20150402
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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 500+ biopharmaceutical companies globally:

Chubb
Fuji
McKesson
Medtronic
Novartis
Baxter
Accenture
Boehringer Ingelheim
Queensland Health
Cerilliant

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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ISSN: 2162-2639

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