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Last Updated: May 20, 2024

Specgx Llc Company Profile


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Summary for Specgx Llc
International Patents:10
US Patents:1
Tradenames:47
Ingredients:31
NDAs:60
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 HYDROMORPHONE HYDROCHLORIDE hydromorphone hydrochloride TABLET;ORAL 076855-001 Dec 23, 2004 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc MORPHINE SULFATE morphine sulfate TABLET, EXTENDED RELEASE;ORAL 076412-002 Jul 31, 2003 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc LISDEXAMFETAMINE DIMESYLATE lisdexamfetamine dimesylate CAPSULE;ORAL 211840-006 Aug 25, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc IMIPRAMINE HYDROCHLORIDE imipramine hydrochloride TABLET;ORAL 087846-002 May 22, 1984 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc LISDEXAMFETAMINE DIMESYLATE lisdexamfetamine dimesylate CAPSULE;ORAL 211840-003 Aug 25, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc VIGABATRIN vigabatrin FOR SOLUTION;ORAL 212626-001 Jul 28, 2021 DISCN No No ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-001 Mar 1, 2010 DISCN Yes 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 RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991 5,326,758 ⤷  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 021217-004 Aug 24, 2012 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 021217-003 Mar 1, 2010 5,914,131 ⤷  Try a Trial
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991 5,030,632 ⤷  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
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 132017000142109 Italy ⤷  Try a Trial PRODUCT NAME: NALTREXONE/BUPROPIONE(MYSIMBA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/988, 20150330
1644019 122013000079 Germany ⤷  Try a Trial PRODUCT NAME: LISDEXAMFETAMINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DESSEN, WIE L-LYSIN-D-AMPHETAMIN-MESYLAT; REGISTRATION NO/DATE: 86155.00.00 86156.00.00 86157.00.00 20130318; FIRST REGISTRATION: UK PL 08081/0050-2 20130201
0566709 SPC/GB04/012 United Kingdom ⤷  Try a Trial PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
1644019 SPC/GB13/052 United Kingdom ⤷  Try a Trial PRODUCT NAME: LISDEXAMFETAMINE OPTIONALLY IN THE FORM OF A MESYLATE OR HYDROCHLORIDE SALT THEREOF; REGISTERED: UK PL08081/0050-2 20130201; UK PL08081/0062-4 20130201
0836511 CA 2006 00019 Denmark ⤷  Try a Trial PRODUCT NAME: FENTANYL HYDROCHLORID
0901368 C300523 Netherlands ⤷  Try a Trial PRODUCT NAME: FENTANYL; REGISTRATION NO/DATE: EU/2/11/127/001 20111006
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
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