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Last Updated: May 31, 2023

Specgx Llc Company Profile


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Summary for Specgx Llc
International Patents:10
US Patents:1
Tradenames:46
Ingredients:30
NDAs:58
Drug Master File Entries: 73

Drugs and US Patents for Specgx Llc

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Specgx Llc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET, EXTENDED RELEASE;ORAL 202608-002 Dec 28, 2012 BX RX No No ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc FENTANYL CITRATE fentanyl citrate TROCHE/LOZENGE;TRANSMUCOSAL 078907-004 Oct 30, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc AMPHETAMINE SULFATE amphetamine sulfate TABLET;ORAL 213583-002 Jan 22, 2021 AA RX No No ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040440-004 Oct 7, 2003 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc MORPHINE SULFATE morphine sulfate SOLUTION;ORAL 202348-001 Jul 15, 2011 AA RX No No ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc BENZPHETAMINE HYDROCHLORIDE benzphetamine hydrochloride TABLET;ORAL 040773-001 Apr 25, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc FENTANYL-50 fentanyl FILM, EXTENDED RELEASE;TRANSDERMAL 077154-002 Feb 9, 2011 AB RX No No ⤷  Try a Trial ⤷  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

Expired US Patents for Specgx Llc

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-002 Mar 1, 2010 5,702,725 ⤷  Try a Trial
Specgx Llc PAMELOR nortriptyline hydrochloride CAPSULE;ORAL 018013-004 Approved Prior to Jan 1, 1982 3,922,305 ⤷  Try a Trial
Specgx Llc PAMELOR nortriptyline hydrochloride CAPSULE;ORAL 018013-001 Approved Prior to Jan 1, 1982 3,922,305 ⤷  Try a Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-001 Mar 1, 2010 5,914,131 ⤷  Try a Trial
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991 5,211,954 ⤷  Try a Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-002 Mar 1, 2010 5,914,131 ⤷  Try a Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-001 Mar 1, 2010 5,702,725 ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for SPECGX LLC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Oral Solution 5 mg/5 mL and 10 mg/5 mL ➤ Subscribe 2010-04-13

Supplementary Protection Certificates for Specgx Llc Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0901368 C300523 Netherlands ⤷  Try a Trial PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
0736030 SPC/GB06/007 United Kingdom ⤷  Try a Trial PRODUCT NAME: POSACONAZOLE, OPTIONALLY IN THE FORM OF AN ESTER OR PHARMACEUTICALLY ACCEPTABLE SALT.; REGISTERED: UK EU/1/05/320/001 20051025; UK EU/1/05/321/001 20051025
2316456 LUC00054 Luxembourg ⤷  Try a Trial PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
0383579 C960030 Netherlands ⤷  Try a Trial PRODUCT NAME: REMIFENTANYLUM, DESGEWENST IN DE VORM VAN EEN ZUURADDITIE-ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: RVG 20601 - RVG 20603 19961015; 36335.00.00, 36335.01.00, 36335.02.00 19960517
0836511 SPC/GB06/022 United Kingdom ⤷  Try a Trial PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
2316456 SPC/GB17/078 United Kingdom ⤷  Try a Trial PRODUCT NAME: NALTREXONE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR NALTREXONE HYDROCHLORIDE, AND BUPROPION OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BUPROPION HYDROCHLORIDE.; REGISTERED: UK EU/1/14/988 20150330; UK PLGB 50742/0001 20150330
2316456 2017C/064 Belgium ⤷  Try a Trial PRODUCT NAME: NALTREXONE/BUPROPION; AUTHORISATION NUMBER AND DATE: EU/1/14/988 20150330
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
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Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
AstraZeneca
Harvard Business School
Colorcon
Moodys

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