COLLEGIUM PHARM INC Company Profile

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COLLEGIUM PHARM INC has four approved drugs.

There are sixteen US patents protecting COLLEGIUM PHARM INC drugs.

There are two hundred and forty patent family members on COLLEGIUM PHARM INC drugs in thirty-one countries and twelve supplementary protection certificates in eleven 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
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	Aug 25, 2011		RX	Yes	No	8,536,130*PED	⤷ Sign Up			Y	⤷ Sign Up
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016		RX	Yes	No	8,557,291	⤷ Sign Up	Y			⤷ Sign Up
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-005	Apr 26, 2016		RX	Yes	Yes	7,399,488	⤷ Sign Up	Y			⤷ 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
Collegium Pharm Inc	NUCYNTA ER	tapentadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200533-002	Aug 25, 2011	8,309,060	⤷ Sign Up
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-002	Apr 26, 2016	9,248,195	⤷ Sign Up
Collegium Pharm Inc	XTAMPZA ER	oxycodone	CAPSULE, EXTENDED RELEASE;ORAL	208090-003	Apr 26, 2016	9,248,195	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Tablets	x50 mg, 75 mg, and 100 mg	➤ Subscribe	2012-11-20
➤ Subscribe	Oral Solution	20 mg/mL	➤ Subscribe	2013-12-20
➤ Subscribe	Oral Solution	20 mg/mL	➤ Subscribe	2013-12-30
➤ Subscribe	Extended-release Tablets	50 mg, 100 mg, 150 mg, 200 mg, and 250 mg	➤ Subscribe	2012-11-20

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1439829	C 2011 002	Romania	⤷ Sign Up	PRODUCT NAME: TAPENTADOL SAU O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: RO 3279/2011/01 - RO 3279/2011/22; DATE OF NATIONAL AUTHORISATION: 20110228; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): DE 75.046; DATE OF FIRST AUTHORISATION IN EEA: 20100819
1685839	92292	Luxembourg	⤷ Sign Up	PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
1439829	99 1-2011	Slovakia	⤷ Sign Up	PRODUCT NAME: TAPENTADOL; NAT. REGISTRATION NO/DATE: 65/0667-0674/10-S, 65/090-0697/10-S 20101012; FIRST REGISTRATION: DE 75043-75048.00.00, 76261-76270.00.00 20100819
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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