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Last Updated: November 23, 2024

TRAMADOL HYDROCHLORIDE Drug Patent Profile

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When do Tramadol Hydrochloride patents expire, and what generic alternatives are available?

Tramadol Hydrochloride is a drug marketed by Actavis Elizabeth, Aurobindo Pharma Ltd, Endo Operations, Lupin Ltd, Mylan, Strides Pharma, Sun Pharm, Accord Hlthcare, Amneal Pharms, Apotex, Asta, Cspc Ouyi Pharm Co, Graviti Pharms, Ipca Labs Ltd, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Merro Pharm Usa, Mylan Pharms Inc, Northstar Hlthcare, Pliva, Rubicon, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Unichem, Watson Labs, Zydus Pharms Usa Inc, Alkem Labs Ltd, Aurobindo Pharma, Chartwell Rx, Micro Labs Ltd India, Nostrum Labs Inc, and Rising. and is included in forty-four NDAs.

The generic ingredient in TRAMADOL HYDROCHLORIDE is acetaminophen; tramadol hydrochloride. There are sixty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the acetaminophen; tramadol hydrochloride profile page.

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Summary for TRAMADOL HYDROCHLORIDE

US Patents:	0
Applicants:	34
NDAs:	44
Finished Product Suppliers / Packagers:	43
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	464
Patent Applications:	2,368
What excipients (inactive ingredients) are in TRAMADOL HYDROCHLORIDE?	TRAMADOL HYDROCHLORIDE excipients list
DailyMed Link:	TRAMADOL HYDROCHLORIDE at DailyMed

Drug patent expirations by year for TRAMADOL HYDROCHLORIDE

Recent Clinical Trials for TRAMADOL HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University Hospital "Sestre Milosrdnice"	N/A
Damascus University	N/A
Baskent University	Phase 4

See all TRAMADOL HYDROCHLORIDE clinical trials

Pharmacology for TRAMADOL HYDROCHLORIDE

Drug Class	Opioid Agonist
Mechanism of Action	Full Opioid Agonists

Medical Subject Heading (MeSH) Categories for TRAMADOL HYDROCHLORIDE

Analgesics, Opioid
Narcotics

Anatomical Therapeutic Chemical (ATC) Classes for TRAMADOL HYDROCHLORIDE

N02AX	Other opioids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

Paragraph IV (Patent) Challenges for TRAMADOL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYZOLT	Extended-release Tablets	tramadol hydrochloride	100 mg, 200 mg and 300 mg	021745	1	2009-06-18
ULTRAM ER	Extended-release Tablets	tramadol hydrochloride	300 mg	021692	1	2007-09-25
ULTRAM ER	Extended-release Tablets	tramadol hydrochloride	200 mg	021692	1	2007-03-28
ULTRAM ER	Extended-release Tablets	tramadol hydrochloride	100 mg	021692	1	2007-01-08

US Patents and Regulatory Information for TRAMADOL HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pliva	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075982-001	Jul 1, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Graviti Pharms	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075968-001	Jun 25, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Industries	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	076100-001	Jun 20, 2002		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Micro Labs Ltd India	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	acetaminophen; tramadol hydrochloride	TABLET;ORAL	201952-001	Dec 14, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rubicon	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	208708-002	Jun 28, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET;ORAL	075977-001	Jun 19, 2002	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN	acetaminophen; tramadol hydrochloride	TABLET;ORAL	090485-001	Dec 9, 2009	AB	RX	No	Yes	⤷ Sign Up	⤷ 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

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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 verification 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.