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, 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: | 34 |
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 |
Pharmacology for TRAMADOL HYDROCHLORIDE
Drug Class | Opioid Agonist |
Mechanism of Action | Full Opioid Agonists |
Medical Subject Heading (MeSH) Categories for TRAMADOL HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for TRAMADOL HYDROCHLORIDE
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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Actavis Elizabeth | TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 091609-002 | Jun 27, 2012 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Graviti Pharms | TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET;ORAL | 075968-002 | Aug 2, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Accord Hlthcare | TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET;ORAL | 202390-001 | May 16, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Janssen Pharms | ULTRAM | tramadol hydrochloride | TABLET;ORAL | 020281-001 | Mar 3, 1995 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ipca Labs Ltd | TRAMADOL HYDROCHLORIDE | tramadol hydrochloride | TABLET;ORAL | 201973-001 | Nov 16, 2012 | AB | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Valeant Pharms | ULTRAM ER | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021692-001 | Sep 8, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Purdue Pharma | RYZOLT | tramadol hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021745-003 | 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 |
Cipher Pharms Inc | CONZIP | tramadol hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 022370-001 | May 7, 2010 | ⤷ Sign Up | ⤷ Sign Up |
Janssen Pharms | ULTRAM | tramadol hydrochloride | TABLET;ORAL | 020281-001 | Mar 3, 1995 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for TRAMADOL HYDROCHLORIDE
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
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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