TRAMADOL HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for tramadol hydrochloride and what is the scope of patent protection?

Tramadol hydrochloride is the generic ingredient in seven branded drugs marketed by Cipher Pharms Inc, Athena, Purdue Pharma, Actavis Elizabeth, Aurobindo Pharma Ltd, Endo Operations, Lupin Ltd, Mylan, Strides Pharma, Sun Pharm, Valeant Pharms, Shionogi Inc, Accord Hlthcare, ACI, 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, and Janssen Pharms, and is included in thirty-nine NDAs. There are two patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tramadol hydrochloride has one patent family member in one country.

There are thirty-four drug master file entries for tramadol hydrochloride. Forty-eight suppliers are listed for this compound.

Summary for TRAMADOL HYDROCHLORIDE

International Patents:	1
US Patents:	2
Tradenames:	7
Applicants:	35
NDAs:	39
Drug Master File Entries:	34
Finished Product Suppliers / Packagers:	48
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	464
Patent Applications:	3,627
What excipients (inactive ingredients) are in TRAMADOL HYDROCHLORIDE?	TRAMADOL HYDROCHLORIDE excipients list
DailyMed Link:	TRAMADOL HYDROCHLORIDE at DailyMed

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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Glossary

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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
Aurobindo Pharma Ltd	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	204421-002	Oct 20, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	200491-001	Jun 27, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	TRAMADOL HYDROCHLORIDE	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	201384-003	Dec 7, 2011	AB1	RX	No	No	⤷ 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

Expired US Patents for TRAMADOL HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-001	Dec 30, 2008	⤷ Sign Up	⤷ Sign Up
Purdue Pharma	RYZOLT	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021745-003	Dec 30, 2008	⤷ Sign Up	⤷ Sign Up
Valeant Pharms	ULTRAM ER	tramadol hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021692-003	Sep 8, 2005	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for TRAMADOL HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2021092406		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TRAMADOL HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0566709	C300152	Netherlands	⤷ Sign Up	PRODUCT NAME: TRAMADOLI HYDROCHLORIDUM EN PARACETAMOLUM; NAT. REGISTRATION NO/DATE: RVG 28113 20030115; FIRST REGISTRATION: 359 228-3 2002050405
0566709	SPC/GB04/012	United Kingdom	⤷ Sign Up	PRODUCT NAME: TRAMADOL HYDROCHLORIDE, PARACETAMOL; REGISTERED: FR NL 25970 20020405; UK PL 00242/0384 20030925
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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