OXALIPLATIN - Generic Drug Details

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What are the generic sources for oxaliplatin and what is the scope of patent protection?

Oxaliplatin is the generic ingredient in two branded drugs marketed by Sanofi Aventis Us, Accord Hlthcare, Actavis, Actavis Totowa, Am Regent, Chartwell Molecular, Eugia Pharma, Fresenius Kabi Oncol, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hengrui Pharma, Hospira Inc, Hospira Worldwide, Meitheal, Mylan Labs Ltd, Norvium Bioscience, Novast Labs, Qilu Pharm Hainan, Sandoz, Sun Pharm, and Teva Pharms, and is included in twenty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for oxaliplatin. Nineteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for OXALIPLATIN

US Patents:	0
Tradenames:	2
Applicants:	22
NDAs:	29
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	2,082
Patent Applications:	951
Drug Prices:	Drug price trends for OXALIPLATIN
What excipients (inactive ingredients) are in OXALIPLATIN?	OXALIPLATIN excipients list
DailyMed Link:	OXALIPLATIN at DailyMed

See drug prices for OXALIPLATIN

Recent Clinical Trials for OXALIPLATIN

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

Sponsor	Phase
Oncotelic Inc.	Phase 2/Phase 3
State University of New York - Downstate Medical Center	Phase 1/Phase 2
Peking University	N/A

See all OXALIPLATIN clinical trials

Generic filers with tentative approvals for OXALIPLATIN

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	5MG/ML	INJECTABLE; INJECTION
⤷ Sign Up	⤷ Sign Up	100MG/20ML (5MG/ML)	INJECTABLE;INTRAVENOUS
⤷ Sign Up	⤷ Sign Up	50MG/10ML (5MG/ML)	INJECTABLE;INTRAVENOUS

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for OXALIPLATIN

Drug Class	Platinum-based Drug

Anatomical Therapeutic Chemical (ATC) Classes for OXALIPLATIN

L01XA	Platinum compounds
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for OXALIPLATIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ELOXATIN	Injection	oxaliplatin	5 mg/mL, 40 mL vials	021759	1	2007-07-16
ELOXATIN	Injection	oxaliplatin	5 mg/mL, 10 mL and 20 mL vials	021759	11	2007-02-09

US Patents and Regulatory Information for OXALIPLATIN

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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
Mylan Labs Ltd	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	091358-001	Aug 7, 2012	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	207562-001	Oct 16, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	207562-002	Oct 16, 2018	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	202922-001	Apr 8, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	078812-001	Aug 7, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	204378-001	May 12, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Qilu Pharm Hainan	OXALIPLATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	204368-001	Jun 7, 2016	AP	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 OXALIPLATIN

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-001	Jan 31, 2005	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021492-001	Aug 9, 2002	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-001	Jan 31, 2005	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-003	Nov 17, 2006	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021492-002	Aug 9, 2002	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-002	Jan 31, 2005	⤷ Sign Up	⤷ Sign Up
Sanofi Aventis Us	ELOXATIN	oxaliplatin	INJECTABLE;INTRAVENOUS	021759-003	Nov 17, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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