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Serving 500+ biopharmaceutical companies globally:

Dow
Merck
Julphar
Chubb
Covington
Farmers Insurance
Express Scripts
Novartis
Harvard Business School
Baxter

Generated: July 22, 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 four hundred and ninety-nine 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 Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-002Oct 7, 2011DISCNYesNo8,168,637► SubscribeY ► Subscribe
Merck Sharp Dohme
ISENTRESS
raltegravir potassium
POWDER;ORAL205786-001Dec 20, 2013RXYesYes7,754,731► SubscribeYY ► Subscribe
Merck Kgaa
NOVOTHYROX
levothyroxine sodium
TABLET;ORAL021292-012May 31, 2002DISCNNoNo► Subscribe► Subscribe
Merck Sharp Dohme
LIPTRUZET
atorvastatin calcium; ezetimibe
TABLET;ORAL200153-003May 3, 2013DISCNYesNoRE42461*PED► Subscribe ► Subscribe
Merck Sharp Dohme
JUVISYNC
simvastatin; sitagliptin phosphate
TABLET;ORAL202343-003Oct 7, 2011DISCNYesNo7,125,873► SubscribeY ► Subscribe
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Expired Patents for Merck

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck
EMEND
aprepitant
CAPSULE;ORAL021549-003Jun 30, 20066,048,859► Subscribe
Merck
PRINZIDE
hydrochlorothiazide; lisinopril
TABLET;ORAL019778-002Feb 16, 19894,472,380► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-002Apr 26, 20075,681,590*PED► Subscribe
Merck
FOSAMAX PLUS D
alendronate sodium; cholecalciferol
TABLET;ORAL021762-002Apr 26, 20076,090,410*PED► Subscribe
Merck
DOLOBID
diflunisal
TABLET;ORAL018445-001Apr 19, 19823,674,870► 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
6,544,967 Method for inhibiting bone resorption► Subscribe
7,674,790Processes of making and using pharmaceutical formulations of antineoplastic agents► Subscribe
6,803,357 Method of regulating glucose metabolism, and reagents related thereto► Subscribe
5,714,490 Tetrahydrofuran antifungals► Subscribe
5,512,570 Treatment of emesis with morpholine 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
Norway331428► Subscribe
Japan2014051533► Subscribe
Denmark0896538► Subscribe
Norway20013988► Subscribe
Ukraine108351► 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
C0010France► SubscribePRODUCT NAME: APREPITANT; REGISTRATION NO/DATE: EU/1/03/262/001 20031111
2014000071Germany► SubscribePRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, GESCHUETZT DURCH DAS GRUNDPATENT EP 1 506 211; REGISTRATION NO/DATE: EU/1/13/900 20140116
2006 00002Denmark► Subscribe
2016 00069Denmark► SubscribePRODUCT NAME: ELBASVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1119 20160726
/1997Austria► SubscribePRODUCT NAME: ATORVASTATIN CALCIUM; NAT. REGISTRATION NO/DATE: 1-21926, 1-21927, 1-21928 19970411; FIRST REGISTRATION: GB PL 00018/0240 - PL 00018/0242 19961107
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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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Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Farmers Insurance
Cerilliant
Citi
Argus Health
Teva
Daiichi Sankyo
US Army
McKinsey
Fuji

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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