Merck Sharp Dohme Company Profile

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MERCK SHARP DOHME has twenty-three approved drugs.

There are twenty-five US patents protecting MERCK SHARP DOHME drugs.

There are six hundred and ninety patent family members on MERCK SHARP DOHME drugs in sixty-three countries and one hundred and twenty-seven supplementary protection certificates in nineteen countries.

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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		⤷ Try a Trial				⤷ Try a Trial
Merck Sharp Dohme	NOXAFIL	posaconazole	TABLET, DELAYED RELEASE;ORAL	205053-001	Nov 25, 2013	AB	RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006		RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Merck Sharp Dohme	NOXAFIL	posaconazole	SOLUTION;INTRAVENOUS	205596-001	Mar 13, 2014	AP	RX	Yes	Yes		⤷ Try a Trial				⤷ Try a Trial
Merck Sharp Dohme	VERQUVO	vericiguat	TABLET;ORAL	214377-001	Jan 19, 2021		RX	Yes	No	9,604,948	⤷ Try a Trial	Y	Y		⤷ Try a 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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-004	Sep 18, 2012	7,078,381	⤷ Try a Trial
Merck Sharp Dohme	PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER	famotidine	INJECTABLE;INJECTION	020249-001	Feb 18, 1994	4,283,408*PED	⤷ Try a Trial
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015	7,820,660	⤷ Try a Trial
Merck Sharp Dohme	TEMODAR	temozolomide	CAPSULE;ORAL	021029-003	Aug 11, 1999	5,260,291*PED	⤷ Try a Trial
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-001	Jun 3, 1998	6,472,373*PED	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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	Tablets	100 mg/10 mg and 100 mg/40 mg	➤ Subscribe	2012-06-19
➤ Subscribe	Tablets	50 mg/10 mg, 50 mg/20 mg, and 50 mg/40 mg	➤ Subscribe	2012-11-06
➤ Subscribe	Capsules	140 mg and 180 mg	➤ Subscribe	2008-03-24
➤ Subscribe	Delayed-release Tablets	100 mg	➤ Subscribe	2014-06-16
➤ Subscribe	Tablets	5 mg	➤ Subscribe	2006-06-21
➤ Subscribe	Tablets	25 mg, 50 mg and 100 mg	➤ Subscribe	2010-10-18
➤ Subscribe	Tablets	100 mg/10 mg and 100 mg/40 mg	➤ Subscribe	2012-06-25

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1084705	CR 2014 00063	Denmark	⤷ Try a Trial	PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070323
1084705	CA 2014 00063	Denmark	⤷ Try a Trial	PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070321
1412357	122008000046	Germany	⤷ Try a Trial	PRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE SITAGLIPTINPHOSPHAT- MONOHYDRAT, IN KOMBINATION MIT METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716 FIRST REGISTRATION: CH/LI 58450 01 58450 02 58450 03 20080408
1441735	08C0026	France	⤷ Try a Trial	PRODUCT NAME: RALTEGRAVIR POTASSIUM; REGISTRATION NO/DATE: EU/1/07/436/001 20080102
1622880	C 2018 027	Romania	⤷ Try a Trial	PRODUCT NAME: LETERMOVIR SAU SAREA SA, SOLVATUL SAU, SAU SOLVATUL SARII SALE; NATIONAL AUTHORISATIONNUMBER: EU/1/17/1245; DATE OF NATIONAL AUTHORISATION: 20180108; NUMBER OF FIRST AUTHORISATION IN EU ROPEAN ECONOMIC AREA (EEA): EU/1/17/1245; DATE OF FIRST AUTHORISATION IN EEA: 20180108
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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