Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: December 9, 2019

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MERCK SHARP DOHME Company Profile

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

MERCK SHARP DOHME has fifty-two approved drugs.

There are forty-seven US patents protecting MERCK SHARP DOHME drugs. There is one tentative approval on MERCK SHARP DOHME drugs.

There are nine hundred and eighty-seven patent family members on MERCK SHARP DOHME drugs in sixty-seven countries and two hundred and twenty-nine supplementary protection certificates in eighteen countries.

Summary for MERCK SHARP DOHME
International Patents:987
US Patents:47
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 JANUVIA sitagliptin phosphate TABLET;ORAL 021995-001 Oct 16, 2006 RX Yes No 6,699,871   Start Trial Y Y   Start Trial
Merck Sharp Dohme PREVYMIS letermovir TABLET;ORAL 209939-002 Nov 8, 2017 RX Yes Yes   Start Trial   Start Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 RX Yes Yes 7,754,731*PED   Start Trial Y   Start Trial
Merck Sharp Dohme ISENTRESS raltegravir potassium TABLET;ORAL 022145-001 Oct 12, 2007 RX Yes Yes 7,169,780*PED   Start Trial Y   Start Trial
Merck Sharp Dohme JANUMET XR metformin hydrochloride; sitagliptin phosphate TABLET, EXTENDED RELEASE;ORAL 202270-003 Feb 2, 2012 RX Yes Yes 7,459,428   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for MERCK SHARP DOHME

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-002 Oct 16, 2006 7,459,428   Start Trial
Merck Sharp Dohme CLARINEX desloratadine TABLET;ORAL 021165-001 Dec 21, 2001 7,211,582*PED   Start Trial
Merck Sharp Dohme SINEMET carbidopa; levodopa TABLET;ORAL 017555-002 Approved Prior to Jan 1, 1982 3,830,827   Start Trial
Merck Sharp Dohme JANUVIA sitagliptin phosphate TABLET;ORAL 021995-003 Oct 16, 2006 6,303,661   Start Trial
Merck Sharp Dohme JUVISYNC simvastatin; sitagliptin phosphate TABLET;ORAL 202343-005 Sep 18, 2012 6,303,661   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for MERCK SHARP DOHME drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Oral Suspension 40 mg/mL ➤ Subscribe 2011-02-28
➤ Subscribe Injection 18 mg/mL, 16.7 mL vials ➤ Subscribe 2015-11-24
➤ 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
Premature patent expirations for MERCK SHARP DOHME

Expiration due to failure to pay maintenance fee

Patent Number Expiration Date
  Start Trial   Start Trial

Supplementary Protection Certificates for MERCK SHARP DOHME Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1622880 300933 Netherlands   Start Trial PRODUCT NAME: LETERMOVIR; REGISTRATION NO/DATE: EU/1/17/1245 20180110
2310095 CA 2016 00070 Denmark   Start Trial PRODUCT NAME: GRAZOPREVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/16/1119 20160726
1412357 07C0041 France   Start Trial PRODUCT 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
1084705 C300705 Netherlands   Start Trial PRODUCT NAME: SITAGLIPTINE; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
0480717 98C0025 Belgium   Start Trial PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Harvard Business School
AstraZeneca
Merck
Moodys
Baxter
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.