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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
US Army
Cerilliant
Fish and Richardson
Medtronic
Express Scripts
Citi
Argus Health
Chinese Patent Office
Teva

Generated: October 20, 2017

DrugPatentWatch Database Preview

MERCK Company Profile

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

MERCK has one hundred and twenty-nine approved drugs.

There are seventy-six US patents protecting MERCK drugs and there have been four Paragraph IV challenges on MERCK drugs in the past three years.

There are one thousand five hundred and twelve patent family members on MERCK drugs in seventy countries and two hundred and forty supplementary protection certificates in fifteen countries.

Summary for Applicant: MERCK

International Patents:1512
US Patents:76
Tradenames:105
Ingredients:87
NDAs:129
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;ORAL202343-002Oct 7, 2011DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Merck
MAXALT
rizatriptan benzoate
TABLET;ORAL020864-002Jun 29, 1998ABRXYesYes► Subscribe► Subscribe► Subscribe
Merck
TRUSOPT
dorzolamide hydrochloride
SOLUTION/DROPS;OPHTHALMIC020408-001Dec 9, 1994ATRXYesYes► Subscribe► Subscribe► Subscribe
Merck
PRINIVIL
lisinopril
TABLET;ORAL019558-002Dec 29, 1987ABRXNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
ISENTRESS HD
raltegravir potassium
TABLET;ORAL022145-002May 26, 2017RXYesNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
STROMECTOL
ivermectin
TABLET;ORAL050742-001Nov 22, 1996DISCNNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
REBETOL
ribavirin
CAPSULE;ORAL020903-001Jun 3, 1998DISCNNoNo► Subscribe► SubscribeY► Subscribe
Merck Kgaa
LEVOTHYROXINE SODIUM
levothyroxine sodium
TABLET;ORAL076752-006Jun 16, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
REBETOL
ribavirin
CAPSULE;ORAL020903-002Jul 25, 2001ABRXYesYes► Subscribe► SubscribeY► Subscribe
Merck
DECADRON
dexamethasone
TABLET;ORAL011664-004Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Merck

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme
ASMANEX TWISTHALER
mometasone furoate
POWDER;INHALATION021067-001Mar 30, 2005► Subscribe► Subscribe
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-002Sep 29, 1995► Subscribe► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-001Oct 7, 2011► Subscribe► Subscribe
Merck
VIOXX
rofecoxib
SUSPENSION;ORAL021052-001May 20, 1999► Subscribe► Subscribe
Merck Sharp Dohme
COZAAR
losartan potassium
TABLET;ORAL020386-001Apr 14, 1995► Subscribe► Subscribe
Merck
DOLOBID
diflunisal
TABLET;ORAL018445-002Apr 19, 1982► Subscribe► Subscribe
Merck Sharp Dohme
ASMANEX HFA
mometasone furoate
AEROSOL, METERED;INHALATION205641-002Apr 25, 2014► Subscribe► Subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
SOLUTION;ORAL021300-001Sep 1, 2004► Subscribe► Subscribe
Merck Sharp Dohme
ELOCON
mometasone furoate
CREAM;TOPICAL019625-001May 6, 1987► Subscribe► Subscribe
Merck Sharp Dohme
LOTRISONE
betamethasone dipropionate; clotrimazole
CREAM;TOPICAL018827-001Jul 10, 1984► Subscribe► Subscribe
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Paragraph IV activity for MERCK drugs

Drugname Dosage Strength Tradename Submissiondate
aprepitant
for Oral Suspension125 mg/Kit
EMEND
11/23/2016
posaconazole
Injection18 mg/mL, 16.7 mL vials
NOXAFIL
11/24/2015
levothyroxine sodium
for Injection200 mcg/vial
LEVOTHYROXINE SODIUM
5/1/2015
levothyroxine sodium
for Injection100 mcg/vial and 500 mcg/vial
LEVOTHYROXINE SODIUM
4/14/2015
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
fosaprepitant dimeglumine
Injection150 mg/vial
EMEND
1/25/2012
fosaprepitant dimeglumine
Injection115 mg/vial
EMEND
1/25/2012
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
caspofungin acetate
For Injection50 mg/vial and 70 mg/vial
CANCIDAS
6/26/2009
aprepitant
Capsule40 mg, 80 mg and 125 mg
EMEND
11/3/2008
temozolomide
Capsules140 mg and 180 mg
TEMODAR
3/24/2008
alendronate sodium and cholecalciferol
Tablets70 mg/2800 IU and 70 mg/5600 IU
FOSAMAX PLUS D
11/20/2007
alendronate sodium
Oral Solution70 mg/75 mL
FOSAMAX
9/7/2007
montelukast
Tablets10 mg
SINGULAIR
2/20/2007
montelukast sodium
Chewable Tablets4 mg and 5 mg
SINGULAIR
12/26/2006
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
rizatriptan benzoate
Orally Disintegrating Tablets5 mg and 10 mg
MAXALT-MLT
2/17/2006
dorzolamide hydrochloride
Ophthalmic Solution2%
TRUSOPT
10/11/2005
rizatriptan benzoate
Tablets5 mg and 10 mg
MAXALT
9/2/2004
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

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
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Non-Orange Book Patents for Merck

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
6,939,550 Stabilized antihistamine syrup► Subscribe
9,200,088Sulfoalkyl ether cyclodextrin compositions► Subscribe
5,714,490 Tetrahydrofuran antifungals► Subscribe
7,244,721Peptides as NS3-serine protease inhibitors of hepatitis C virus► Subscribe
7,157,429Method of regulating glucose metabolism, and reagents related thereto► Subscribe
6,229,010 Polymorphic form of a tachykinin receptor antagonist► Subscribe
7,592,316Peptides as NS3-serine protease inhibitors of hepatitis C virus► Subscribe
6,583,142 Polymorphic form of a tachykinin receptor antagonist► Subscribe
5,693,626 Tetrahydrofuran antifungals► Subscribe
5,780,467 Morpholine compounds are prodrugs useful as tachykinin receptor antagonists► 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 Drugs

Country Document Number Estimated Expiration
Australia721477► Subscribe
Japan3762407► Subscribe
European Patent Office1487426► Subscribe
Japan2001510442► Subscribe
South Korea20030097628► Subscribe
EcuadorSP045082► Subscribe
Argentina037713► Subscribe
Canada2254061► Subscribe
Slovakia156798► Subscribe
Japan2001521000► 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 Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00104Netherlands► SubscribePRODUCT NAME: ERTAPENEM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER ERTAPENEMNATRIUM; NAT. REGISTRATION NO/DATE: EU/1/02/216/001 20020418; FIRST REGISTRATION: EU/1/02/216/001 20020418
01/029Ireland► SubscribePRODUCT NAME: CASPOFUNGIN, OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALT, ESPECIALLY CASPOFUNGIN ACETATE; REGISTRATION NO/DATE: EU/1/01/196/001-003 20011024; PAEDIATRIC INV. PLAN: P/30/2008
2014 00037Denmark► SubscribePRODUCT NAME: ET KOMBINATIONSPRODUKT AF DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER DAPAGLIFLOZINPROPANDIOLMONOHYDRAT OG METFORMIN ELLER SALTE DERAF, HERUNDER METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/13/900 20140116
C/GB14/083United Kingdom► SubscribePRODUCT NAME: ALOGLIPTIN; REGISTERED: UK EU/1/13/844 20130923
C0022France► SubscribePRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825
C/GB14/084United Kingdom► SubscribePRODUCT NAME: LINAGLIPTIN; REGISTERED: UK EU/1/11/707/001-011 20110830
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
0858Netherlands► SubscribePRODUCT NAME: ELBASVIR DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/16/1119 20160726
2007006,C1412357Lithuania► SubscribePRODUCT NAME: SITAGLIPTINUM; REGISTRATION NO/DATE: EU/1/07/383/001-EU/1/07/383/018 20070321
364Luxembourg► Subscribe91364, EXPIRES: 20200826
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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:

Farmers Insurance
Deloitte
AstraZeneca
Accenture
Baxter
Covington
McKesson
Daiichi Sankyo
Federal Trade Commission
Colorcon

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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