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Last Updated: December 13, 2024

Collegium Pharm Inc Company Profile


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Summary for Collegium Pharm Inc
International Patents:240
US Patents:16
Tradenames:3
Ingredients:2
NDAs:4

Drugs and US Patents for Collegium Pharm Inc

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 XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-001 Apr 26, 2016 RX Yes No 8,449,909 ⤷  Sign Up Y ⤷  Sign Up
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-001 Nov 20, 2008 RX Yes No ⤷  Sign Up ⤷  Sign Up
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 Nov 20, 2008 RX Yes No 7,994,364*PED ⤷  Sign Up Y ⤷  Sign Up
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-001 Aug 25, 2011 RX Yes No 11,344,512*PED ⤷  Sign Up Y ⤷  Sign Up
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-002 Apr 26, 2016 RX Yes No 8,758,813 ⤷  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

Expired US Patents for Collegium Pharm Inc

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 11,007,156 ⤷  Sign Up
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-002 Nov 20, 2008 RE39593 ⤷  Sign Up
Collegium Pharm Inc NUCYNTA tapentadol hydrochloride TABLET;ORAL 022304-003 Nov 20, 2008 RE39593 ⤷  Sign Up
Collegium Pharm Inc NUCYNTA ER tapentadol hydrochloride TABLET, EXTENDED RELEASE;ORAL 200533-005 Aug 25, 2011 11,007,156 ⤷  Sign Up
Collegium Pharm Inc XTAMPZA ER oxycodone CAPSULE, EXTENDED RELEASE;ORAL 208090-001 Apr 26, 2016 9,763,883 ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for COLLEGIUM PHARM INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ Subscribe Tablets x50 mg, 75 mg, and 100 mg ➤ Subscribe 2012-11-20
➤ Subscribe Oral Solution 20 mg/mL ➤ Subscribe 2013-12-20

Supplementary Protection Certificates for Collegium Pharm Inc Drugs

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
0693475 PA2011007 Lithuania ⤷  Sign Up PRODUCT NAME: TAPENTADOLUM; NAT. REGISTRATION NO/DATE: LT/1/10/2341/001 - LT/1/10/2341/66, 2011 02 19; LT/1/10/2342/001 - LT/1/10/2342/110 20110219; FIRST REGISTRATION: 75043.00.00 - 75048.00.00, 2010 08 19; 76261.00.00 - 76270.00.00 20100819
0693475 PA2011007,C0693475 Lithuania ⤷  Sign Up PRODUCT NAME: TAPENTADOLUM; NAT. REGISTRATION NO/DATE: LT/1/10/2341/001 - LT/1/10/2341/66, 2011 02 19; LT/1/10/2342/001 - LT/1/10/2342/110 20110219; FIRST REGISTRATION: 75043.00.00 - 75048.00.00, 2010 08 19; 76261.00.00 - 76270.00.00 20100819
0693475 SPC/GB11/031 United Kingdom ⤷  Sign Up PRODUCT NAME: TAPENTADOL IN THE FORM OF ITS BASE OR A SALT OF A PHYSIOLOGICALLY COMPATIBLE ACID, ESPECIALLY THE HYDROCHLORIDE SALT.; REGISTERED: DE 75043 20100819; UK PL 21727/0032 - 0050 20110204
0693475 C00693475/01 Switzerland ⤷  Sign Up PRODUCT NAME: TAPENTADOL; REGISTRATION NO/DATE: SWISSMEDIC 60530 20110222
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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