Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

AstraZeneca
McKesson
Express Scripts
Johnson and Johnson
Medtronic
Dow

Last Updated: October 22, 2019

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Specgx Llc Company Profile

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What is the competitive landscape for SPECGX LLC, and what generic alternatives to SPECGX LLC drugs are available?

SPECGX LLC has fifty-one approved drugs.

There is one US patent protecting SPECGX LLC drugs.

There are ten patent family members on SPECGX LLC drugs in nine countries and twenty supplementary protection certificates in nine countries.

Summary for Specgx Llc
International Patents:10
US Patents:1
Tradenames:39
Ingredients:25
NDAs:51
Drug Master File Entries: 73
Patent Litigation for Specgx Llc: See patent lawsuits for Specgx Llc

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 TOFRANIL-PM imipramine pamoate CAPSULE;ORAL 017090-002 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial
Specgx Llc OXYMORPHONE HYDROCHLORIDE oxymorphone hydrochloride TABLET;ORAL 202321-001 Apr 25, 2013 AB RX No No   Start Trial   Start Trial
Specgx Llc TOFRANIL-PM imipramine pamoate CAPSULE;ORAL 017090-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial
Specgx Llc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040440-007 Oct 7, 2003 AB RX No No   Start Trial   Start Trial
Specgx Llc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride TABLET;ORAL 040300-001 Nov 27, 1998 AB RX No No   Start Trial   Start Trial
Specgx Llc METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 203583-002 Sep 29, 2015 AB2 RX No No   Start Trial   Start 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 PAMELOR nortriptyline hydrochloride CAPSULE;ORAL 018013-001 Approved Prior to Jan 1, 1982 3,922,305   Start Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-001 Mar 1, 2010 5,914,131   Start Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-003 Mar 1, 2010 5,702,725   Start Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-004 Aug 24, 2012 5,702,725   Start Trial
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991 5,326,758   Start Trial
Specgx Llc EXALGO hydromorphone hydrochloride TABLET, EXTENDED RELEASE;ORAL 021217-004 Aug 24, 2012 5,914,131   Start 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
0566709 SPC/GB04/012 United Kingdom   Start Trial PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
1769785 C300521 Netherlands   Start Trial PRODUCT NAME: FENTANYL; REG NO/DATE: EU/2/11/127/001 20111006
2316456 2017/059 Ireland   Start 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; REGISTRATION NO/DATE: EU/1/14/988 20150326
0836511 122006000022 Germany   Start Trial PRODUCT NAME: TRANSDERMAL IONTOPHORETISCH VERABREICHTES FENTANYL-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/05/326/001 20060126
0836511 SPC/GB06/022 United Kingdom   Start Trial PRODUCT NAME: FENTANYL HYDROCHLORIDE; REGISTERED: UK EU/1/05/326/001 20060124
1635783 CA 2014 00016 Denmark   Start Trial PRODUCT NAME: FENTANYL I EN HVILKEN SOM HELST AF DE FORMER, DER ER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/10/644/001-006 20100831
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Colorcon
Moodys
Boehringer Ingelheim
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.