You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 19, 2026

Details for New Drug Application (NDA): 208468

✉ Email this page to a colleague

« Back to Dashboard

NDA 208468 describes GLATIRAMER ACETATE, which is a drug marketed by Chemi Spa, Hybio, Mylan, Scinopharm Taiwan, and Synthon Pharms Inc, and is included in eight NDAs. It is available from five suppliers. Additional details are available on the GLATIRAMER ACETATE profile page.

The generic ingredient in GLATIRAMER ACETATE is glatiramer acetate. There are five drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the glatiramer acetate profile page.

Summary for 208468

Tradename:	GLATIRAMER ACETATE
Applicant:	Chemi Spa
Ingredient:	glatiramer acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 208468

Adjuvants, Immunologic
Antirheumatic Agents
Immunosuppressive Agents

Suppliers and Packaging for NDA: 208468

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	208468	ANDA	Italfarmaco SpA	11797-764	11797-764-03	30 SYRINGE in 1 CARTON (11797-764-03) / 1 mL in 1 SYRINGE
GLATIRAMER ACETATE	glatiramer acetate	INJECTABLE;SUBCUTANEOUS	208468	ANDA	Italfarmaco SpA	11797-765	11797-765-03	12 SYRINGE in 1 CARTON (11797-765-03) / 1 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	20MG/ML
Approval Date:	May 7, 2025	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;SUBCUTANEOUS			Strength	40MG/ML
Approval Date:	May 7, 2025	TE:	AP	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.