MERCK SHARP DOHME Company Profile

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MERCK SHARP DOHME has twenty-three approved drugs.

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

There are six hundred and ninety-five patent family members on MERCK SHARP DOHME drugs in sixty-three countries and one hundred and thirty 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	PREVYMIS	letermovir	SOLUTION;INTRAVENOUS	209940-001	Nov 8, 2017		RX	Yes	Yes		⤷ Sign Up				⤷ Sign Up
Merck Sharp Dohme	VICTRELIS	boceprevir	CAPSULE;ORAL	202258-001	May 13, 2011		DISCN	No	No	7,772,178	⤷ Sign Up	Y			⤷ Sign Up
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006		RX	Yes	No		⤷ Sign Up				⤷ Sign Up
Merck Sharp Dohme	PREVYMIS	letermovir	TABLET;ORAL	209939-001	Nov 8, 2017		RX	Yes	No	RE46791	⤷ Sign Up	Y	Y		⤷ Sign Up
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-003	Oct 16, 2006		RX	Yes	Yes	7,326,708*PED	⤷ Sign Up			Y	⤷ Sign Up
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-002	Oct 16, 2006		RX	Yes	No		⤷ Sign Up				⤷ Sign Up
>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	CLARINEX	desloratadine	SOLUTION;ORAL	021300-001	Sep 1, 2004	6,514,520*PED	⤷ Sign Up
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-002	Oct 7, 2011	6,303,661	⤷ Sign Up
Merck Sharp Dohme	JUVISYNC	simvastatin; sitagliptin phosphate	TABLET;ORAL	202343-002	Oct 7, 2011	8,168,637	⤷ Sign Up
Merck Sharp Dohme	DUTREBIS	lamivudine; raltegravir potassium	TABLET;ORAL	206510-001	Feb 6, 2015	7,820,660	⤷ Sign Up
Merck Sharp Dohme	JANUVIA	sitagliptin phosphate	TABLET;ORAL	021995-001	Oct 16, 2006	6,303,661	⤷ Sign Up
Merck Sharp Dohme	REBETOL	ribavirin	CAPSULE;ORAL	020903-002	Jul 25, 2001	6,337,090*PED	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	C300340	Netherlands	⤷ Sign Up	PRODUCT NAME: RALTEGRAVIR OF FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER HET KALIUMZOUT; REGISTRATION NO/DATE: EU/1/07/436/001-002 20071220
1412357	2007/029	Ireland	⤷ Sign Up	PRODUCT NAME: SITAGLIPTIN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTRATION NO/DATE: EU/1/07/383/001-018 20070321
1441735	SZ 30/2008	Austria	⤷ Sign Up	PRODUCT NAME: RALTEGRAVIR ODER DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, INSBESONDERE DAS KALIUMSALZ
1622880	CA 2018 00026	Denmark	⤷ Sign Up	PRODUCT NAME: LETERMOVIR, OR ITS SALT, SOLVATE OR SOLVATE OF ITS SALT; REG. NO/DATE: EU/1/17/1245 20180110
1620113	300756	Netherlands	⤷ Sign Up	PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MT MA117/01101 20150402
1412357	122008000046	Germany	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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