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Serving 500+ biopharmaceutical companies globally:

McKesson
Mallinckrodt
Chinese Patent Office
Harvard Business School
Cerilliant
QuintilesIMS
Farmers Insurance
UBS
Cipla
Merck

Generated: September 26, 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 ten patent family members on MERCK drugs in seventy countries.

Summary for Applicant: Merck

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
ALDORIL 15
hydrochlorothiazide; methyldopa
TABLET;ORAL013402-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Merck
COLBENEMID
colchicine; probenecid
TABLET;ORAL012383-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
STROMECTOL
ivermectin
TABLET;ORAL050742-002Oct 8, 1998ABRXYesYes► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-001Oct 16, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
POWDER;ORAL205786-001Dec 20, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Merck Kgaa
NOVOTHYROX
levothyroxine sodium
TABLET;ORAL021292-002May 31, 2002DISCNNoNo► Subscribe► Subscribe► Subscribe
Merck Sharp Dohme
JANUVIA
sitagliptin phosphate
TABLET;ORAL021995-002Oct 16, 2006RXYesNo► Subscribe► Subscribe ► Subscribe
Merck Sharp Dohme
ISENTRESS HD
raltegravir potassium
TABLET;ORAL022145-002May 26, 2017RXYesNo► Subscribe► SubscribeY► Subscribe
Merck
HYDROCORTONE
hydrocortisone acetate
INJECTABLE;INJECTION008228-004Approved Prior to Jan 1, 1982DISCNNoNo► 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
CLARINEX
desloratadine
TABLET, ORALLY DISINTEGRATING;ORAL021312-001Jun 26, 2002► Subscribe► Subscribe
Merck Sharp Dohme
ASMANEX TWISTHALER
mometasone furoate
POWDER;INHALATION021067-001Mar 30, 2005► Subscribe► Subscribe
Merck Sharp Dohme
CLARINEX
desloratadine
TABLET, ORALLY DISINTEGRATING;ORAL021312-002Jul 14, 2005► Subscribe► Subscribe
Merck Sharp Dohme
SINEMET CR
carbidopa; levodopa
TABLET, EXTENDED RELEASE;ORAL019856-001May 30, 1991► Subscribe► Subscribe
Merck
PRINIVIL
lisinopril
TABLET;ORAL019558-001Dec 29, 1987► Subscribe► Subscribe
Merck And Co Inc
FOSAMAX
alendronate sodium
TABLET;ORAL020560-002Sep 29, 1995► Subscribe► Subscribe
Merck Sharp Dohme
DULERA
formoterol fumarate; mometasone furoate
AEROSOL, METERED;INHALATION022518-002Jun 22, 2010► Subscribe► Subscribe
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-002Mar 26, 2003► Subscribe► Subscribe
Merck Sharp Dohme
TEMODAR
temozolomide
CAPSULE;ORAL021029-005Oct 19, 2006► Subscribe► Subscribe
Merck Sharp Dohme
COZAAR
losartan potassium
TABLET;ORAL020386-002Apr 14, 1995► 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
7,829,530Method of regulating glucose metabolism, and reagents related thereto► Subscribe
9,750,822Sulfoalkyl ether cyclodextrin compositions► Subscribe
7,012,066Peptides as NS3-serine protease inhibitors of hepatitis C virus► Subscribe
5,693,626 Tetrahydrofuran antifungals► Subscribe
6,132,758 Stabilized antihistamine syrup► Subscribe
6,495,167 Preparation of powder agglomerates► Subscribe
9,200,088Sulfoalkyl ether cyclodextrin compositions► Subscribe
8,440,668Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of type 2 diabetes► Subscribe
5,780,467 Morpholine compounds are prodrugs useful as tachykinin receptor antagonists► 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 Drugs

Country Document Number Estimated Expiration
Australia681753► Subscribe
Spain2288807► Subscribe
CroatiaP970201► Subscribe
MexicoPA04003932► Subscribe
China1190955► Subscribe
Czech Republic288241► Subscribe
TaiwanI344463► Subscribe
Serbia52534► Subscribe
Iceland8357► Subscribe
Argentina101429► 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
C0118France► SubscribePRODUCT NAME: ATORVASTATINE CALCIQUE TRIHYDRATE; REGISTRATION NO/DATE IN FRANCE: NL 21960 DU 19970321; REGISTRATION NO/DATE AT EEC: PL 00018/0240 DU 19961107
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
00569Netherlands► SubscribePRODUCT NAME: LINAGLIPTINE, DESGEWENST IN DE VORM VAN EEN ZOUT, IN COMBINATIE MET METFORMINEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/12/780/001-028 20120720
C/GB99/043United Kingdom► SubscribePRODUCT NAME: DORZOLAMIDE OR AN OPHTHALMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY DORZOLAMIDE HYDROCHOLORIDE, PLUS TIMOLOL OR AN OPHTHAMOLOGICALLY ACCEPTABLE SALT THEREOF, PREFERABLY TIMOLOL MALEATE; REGISTERED: DK 19045 19980306; UK PL 00025/0373 19980804
5006-2008Slovakia► SubscribePRODUCT NAME: SITAGLIPTIN A METFORMIN; NAT. REG.NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REG.:CH 58450 01-03 20080408
00340Netherlands► SubscribePRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
9Finland► Subscribe
2012022Lithuania► SubscribePRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
3Finland► Subscribe
222Luxembourg► Subscribe91222, EXPIRES: 20200824
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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:

Fuji
Chinese Patent Office
Moodys
Chubb
UBS
Express Scripts
Cipla
Cerilliant
Medtronic
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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ISSN: 2162-2639

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