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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
US Army
UBS
Colorcon
Fish and Richardson
Healthtrust
Citi
Cipla
Argus Health

Generated: September 20, 2018

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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 fifty-two approved drugs.

There are fifty-two US patents protecting MERCK SHARP DOHME drugs.

Summary for Merck Sharp Dohme
US Patents:52
Tradenames:41
Ingredients:33
NDAs:52

Drugs and US Patents for Merck Sharp Dohme

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;ORAL 202343-005 Sep 18, 2012 DISCN Yes No 6,699,871 ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Merck Sharp Dohme LIPTRUZET atorvastatin calcium; ezetimibe TABLET;ORAL 200153-001 May 3, 2013 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme ISENTRESS HD raltegravir potassium TABLET;ORAL 022145-002 May 26, 2017 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-001 Oct 7, 2011 DISCN Yes No 6,890,898 ➤ Try a Free Trial ➤ Try a Free Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 RX Yes No 7,326,708 ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for Merck Sharp Dohme

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme LOTRISONE betamethasone dipropionate; clotrimazole CREAM;TOPICAL 018827-001 Jul 10, 1984 3,705,172 ➤ Try a Free Trial
Merck Sharp Dohme DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-001 Jun 22, 2010 6,068,832 ➤ Try a Free Trial
Merck Sharp Dohme REBETOL ribavirin CAPSULE;ORAL 020903-001 Jun 3, 1998 5,767,097*PED ➤ Try a Free Trial
Merck Sharp Dohme PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER famotidine INJECTABLE;INJECTION 020249-001 Feb 18, 1994 4,283,408*PED ➤ Try a Free Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET, ORALLY DISINTEGRATING;ORAL 021312-002 Jul 14, 2005 5,607,697*PED ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for MERCK SHARP DOHME drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Orally Disintegrating Tablets 2.5 mg and 5 mg ➤ Subscribe 2006-06-21
➤ Subscribe Extended-release Capsules 50 mg/500 mg and 50 mg/1000 mg ➤ Subscribe 2012-03-16
➤ Subscribe Tablets 50 mg/12.5 mg and 100 mg/25 mg ➤ Subscribe 2004-05-24
➤ Subscribe Tablets 50 mg/500 mg and 50 mg/1000 mg ➤ Subscribe 2010-10-18
➤ Subscribe Tablets 100 mg/10 mg and 100 mg/40 mg ➤ Subscribe 2012-06-19
➤ Subscribe Topical Solution (Lotion) 0.10% ➤ Subscribe 2004-06-10
➤ Subscribe Tablets 50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mg ➤ Subscribe 2012-11-06
➤ Subscribe Tablets 400 mg ➤ Subscribe 2011-10-12
➤ Subscribe Delayed-release Tablets 100 mg ➤ Subscribe 2014-06-16
➤ Subscribe Tablets 5 mg ➤ Subscribe 2006-06-21
➤ Subscribe Nasal Spray 50 mcg/ Spray ➤ Subscribe 2009-08-07
➤ Subscribe Extended-release Tablets 100 mg/1000 mg ➤ Subscribe 2012-10-22
➤ Subscribe Tablets 100 mg/12.5 mL ➤ Subscribe 2006-04-04
➤ Subscribe Tablets 25 mg, 50 mg and 100 mg ➤ Subscribe 2010-10-18
➤ Subscribe Capsules 140 mg and 180 mg ➤ Subscribe 2008-03-24
➤ Subscribe Tablets 100 mg/10 mg and 100 mg/40 mg ➤ Subscribe 2012-06-25
➤ Subscribe Injection 1 g/vial ➤ Subscribe 2013-06-20
➤ Subscribe Oral Suspension 40 mg/mL ➤ Subscribe 2011-02-28
➤ Subscribe Injection 18 mg/mL, 16.7 mL vials ➤ Subscribe 2015-11-24
Premature patent expirations for MERCK SHARP DOHME

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
➤ Try a Free Trial ➤ Try a Free Trial

Non-Orange Book US 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
6,939,550 Stabilized antihistamine syrup ➤ Try a Free Trial
2,004,254,117 ➤ Try a Free Trial
9,044,424 Methods of regulating glucose metabolism, and reagents related thereto ➤ Try a Free Trial
7,592,316 Peptides as NS3-serine protease inhibitors of hepatitis C virus ➤ Try a Free Trial
8,440,668 Beta-amino heterocyclic dipeptidyl peptidase inhibitors for the treatment of type 2 diabetes ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Merck Sharp Dohme Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0160050 Estonia ➤ Try a Free Trial (93) SZ 65861 01, 01.04.2016 (93) CH 65861 01, 01.04.2016
2014000088 Germany ➤ Try a Free Trial PRODUCT NAME: EZETIMIB ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON IN KOMBINATION MIT ATORVASTATIN ODER PHARMAZEUTISCH ANNEHMBARE SALZE DAVON, INSBESONDERE ATORVASTATIN ALS ATORVASTATINCALCIUMTRIHYDRAT; NAT. REGISTRATION NO/DATE: 90223.00.00 20141113; FIRST REGISTRATION: FRANKREICH CIS: 6 928 917 6 20140912
C/GB01/012 United Kingdom ➤ Try a Free Trial PRODUCT NAME: DESLORATADINE AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/00/157/001-013 20010115; UK EU/1/00/158/001-013 20010115; UK EU/1/00/159/001-013 20010115; UK EU/1/00/160/001-013 20010115; UK EU/1/00/161/001-013 20010115
C0009 Belgium ➤ Try a Free Trial PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
C0030 France ➤ Try a Free Trial PRODUCT NAME: EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 32075 20060623; FIRST REGISTRATION: LI - 55783 01 20020607
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Mallinckrodt
Cipla
Cantor Fitzgerald
Covington
Express Scripts
Boehringer Ingelheim
Merck
Cerilliant

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