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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Last Updated: November 19, 2019

DrugPatentWatch Database Preview

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for acetaminophen; tramadol hydrochloride and what is the scope of freedom to operate?

Acetaminophen; tramadol hydrochloride is the generic ingredient in two branded drugs marketed by Alkem Labs Ltd, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Cspc Ouyi, Macleods Pharms Ltd, Micro Labs Ltd India, Mylan, Par Pharm, Sun Pharm Inds Inc, Zydus Pharms Usa Inc, and Janssen Pharms, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-six drug master file entries for acetaminophen; tramadol hydrochloride. Twenty-six suppliers are listed for this compound.

Recent Clinical Trials for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

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SponsorPhase
Amsterdam Rheumatology and Immunology CenterPhase 4
Tel-Aviv Sourasky Medical CenterPhase 4
University Hospital, Clermont-FerrandPhase 3

See all ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE clinical trials

Recent Litigation for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Ortho-McNeil Pharmaceutical, Inc. v. Mylan Pharmaceuticals Inc.2008-03-05
ORTHO-MCNEAL PHARMACEUTICAL INC v. TEVA PHARMACEUTICAL INDUSTRIES LTD.
ORTHO-MCNEIL PHARMACEUTICAL, INC. v. WATSON LABORATORIES, INC.

See all ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE litigation

Pharmacology for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Drug ClassOpioid Agonist
Mechanism of ActionFull Opioid Agonists
Paragraph IV (Patent) Challenges for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ULTRACET TABLET;ORAL acetaminophen; tramadol hydrochloride 021123

US Patents and Regulatory Information for ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Janssen Pharms ULTRACET acetaminophen; tramadol hydrochloride TABLET;ORAL 021123-001 Aug 15, 2001 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 207152-001 Mar 22, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 090485-001 Dec 9, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 206885-001 May 2, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Inc TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 077184-001 Dec 16, 2005 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN acetaminophen; tramadol hydrochloride TABLET;ORAL 076475-001 Apr 21, 2005 AB RX No No   Start Trial   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 ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Janssen Pharms ULTRACET acetaminophen; tramadol hydrochloride TABLET;ORAL 021123-001 Aug 15, 2001   Start Trial   Start Trial
Janssen Pharms ULTRACET acetaminophen; tramadol hydrochloride TABLET;ORAL 021123-001 Aug 15, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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