The Therapeutic Equivalence (TE) code for Upsher-Smith's Glatiramer Acetate Injection product is AP, and the Reference Listed Drug (RLD) is the brand COPAXONE® (glatiramer acetate injection)**.
"The launch of Glatiramer Acetate Injection marks another important milestone in Upsher-Smith's efforts to build a diversified portfolio of complex generic medicines," said Jim Maahs, Senior Vice President, Head of Upsher-Smith Commercial. "Bringing a substitutable generic version of this important therapy to market reflects our commitment to delivering quality medicines for patients living with complex neurological conditions while providing products with meaningful value to our customers."
Product Information
Product |
Strength |
NDC # |
Size & Package |
Glatiramer Acetate Injection |
20 mg/mL |
0832-6084-30 |
30 single-dose, prefilled syringes |
Glatiramer Acetate Injection |
40 mg/mL |
0832-6085-12 |
12 single-dose, prefilled syringes |
For questions about ordering, please call Upsher-Smith at 1-800-654-2299.
See full prescribing information for complete boxed warning. WARNING: ANAPHYLACTIC REACTIONS
Life-threatening and fatal anaphylaxis, which can occur at any time following initiation of therapy (from as early as after the first dose, up to years after initiation of treatment), has been reported in patients receiving Glatiramer Acetate Injection.
• Make patients aware of the symptoms of anaphylaxis, which may overlap with those of an immediate post-injection reaction. Prompt identification of anaphylaxis is important to avoid a delay in treatment.
• Glatiramer Acetate Injection is contraindicated in patients with a history of hypersensitivity reactions to Glatiramer Acetate Injection, including anaphylaxis. |
Please refer to the full Prescribing Information, including Boxed Warning, for Glatiramer Acetate Injection here. You can also call 1-888-650-3789 to obtain a copy of the full Prescribing Information. You are encouraged to report suspected adverse reactions to Upsher-Smith Laboratories, LLC at 1-855-899-9180 or to the FDA by visiting http://www.fda.gov/medwatch.
About Upsher-Smith
Upsher-Smith Laboratories, LLC, now a member of Bora Group, is a trusted U.S. pharmaceutical company that strives to improve the health and lives of patients through an unwavering commitment to high-quality products and sustainable growth. We bring generics and brands to a wide array of customers, always backed by our attentive level of service, strong industry relationships, and dedication to uninterrupted supply. For more information, visit www.upsher-smith.com.
About Bora
Founded in 2007, Bora Pharmaceuticals ("Bora" or "the Company", 6472.TW and BORAY.OTCQX) is a leading pharmaceutical services company with a vision and goal of "Contributing to Better Health All Over the World". Operating under a "Dual Engine" model that integrates CDMO and commercial expertise, we empower pharmaceutical and biotech partners to optimize product development, accelerate launches, and scale supply to meet global patient needs. At the same time, we actively broaden R&D and sales infrastructure, focusing on niche and rare disease markets to improve patients' quality of life.
By investing in talent, infrastructure, and biologics expansion, Bora continues to transform operations and achieve sustainable growth. Committed to making success "certain," Bora sets new standards in the pharmaceutical and CDMO industries. For more, please visit: https://www.bora-corp.com and https://www.boracdmo.com.
*June 2025 – May 2026
**Copaxone is a registered trademark of Teva Pharmaceutical Industries Ltd.
SOURCE Upsher-Smith Laboratories, LLC
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