Firazyr authorized generic. Stay informed on drug availability and coverage updates.
Firazyr authorized generic Jul 14, 2025 · Firazyr package insert / prescribing information for healthcare professionals. Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older. Adult patients (or their caregivers) may self-administer FIRAZYR upon recognition of symptoms of an HAE attack. Pharmacology, adverse reactions, warnings, and FIRAZYRside effects. Generic Name Icatibant Form / Color - / - Heat Number - Date of Transitional Measures - Ministry of Health and Welfare Code 4490406G1029 YJ Code 4490406G1029 Manufacturer Takeda Pharmaceutical Company Limited MA holder Takeda Pharmaceutical Company Limited Restriction Information Storage Condition Cautions for Storage - Generic - Authorized Generic - Biosimilar - Carved Seal - Strength 30 mg Icatibant (generic Firazyr) Teva Savings Card Eligible commercially insured patients may pay as little as $0 per prescription; for additional information contact the program at 844-248-7949. After this date, generic versions of icatibant may become available. commercialization deal with Slayback Pharma to launch generic Firazyr (icatibant injection). Oct 12, 2011 · FIRAZYR – Treatment for Hereditary Angioedema FIRAZYR (Icatibant) is a drug developed and manufactured by Jerini, which was taken over by Shire Pharmaceuticals in 2008. No. Takeda’s patent for Firazyr expired in July 2019, making generic options of icatibant now available. Uses Side effects Before taking Dosage What to avoid Interactions FAQ What is icatibant? Icatibant is an injection used to treat acute attacks of hereditary Apr 1, 2014 · For Generic Pharmaceutical Manufacturers For a generic product to be listed on a public drug plan formulary, manufacturers are required to submit the TPF Form electronically to the pCPA for all generic products entering and exiting the Canadian market, including the pan-Canadian Select Molecules. The first administration of FIRAZYR should be performed under the guidance of a healthcare professional before beginning the self-administration of FIRAZYR Explore the CVS Specialty Drug List for comprehensive access to specialty medications covered by your pharmacy benefits. The drug identification number (DIN) is 02425696. Health Care Providers: Visit the CVS Specialty website to download enrollment forms or call 1-800-237-2767 (TTY: 711). Read the latest news and reviews about the drug as well as potential side effects and popular alternatives. Generic A Sensible and Effective Treatment Option Icatibant Injection is FDA-approved, so patients can be assured it is made with quality ingredients and is safe and effective. Growth and Development Effects in Pediatric Patients ment with FIRAZYR in children and adolescents are unknown. Compare Firazyr head-to-head with other drugs for uses, ratings, cost, side effects and interactions. Authorized Generics Quality & Value Prasco partners with many of the world’s most innovative pharmaceutical companies to bring their brand medications to market as Authorized Generics. Feb 1, 2021 · Sandoz is marketing in the US a generic form of icatibant injection, in prefilled syringes, to treat acute attacks of hereditary angioedema in adults. Aug 25, 2011 · Generic Firazyr Availability Last updated on Oct 8, 2025. g. It works by blocking a substance in your body that causes swelling and pain. Oct 15, 2025 · It is not intended to provide practical advice on how to use Firazyr. It is labeled and distributed by Takeda Pharmaceuticals America, Inc. Food and Drug Administration (FDA) for a generic version of Firazyr (icatibant injection), an approved treatment for acute attacks in adults with hereditary angioedema (HAE). Q1: What is the generic name of FIRAZYR? A: The generic name is Icatibant. Q3: What is FIRAZYR used for? A: FIRAZYR is used to treat acute attacks of hereditary angioedema (HAE) in adults. Firazyr's patents have been open to challenges since 26 August, 2015. Feb 27, 2025 · Pronunciation: eye-KAT-i-bant Generic name: icatibant Brand name: Firazyr Dosage form: injection for subcutaneous use Drug class: Hereditary angioedema agents Medically reviewed by Carmen Pope, BPharm. Includes: indications, dosage, adverse reactions and pharmacology. It is a selective competitive B2 bradykinin receptor antagonist and an immunomodulator. 4 – Intellia planning Phase 3 study of NTLA-2002 in 2024 In August, Intellia announced it had wrapped up recruitment for the Phase 2 portion of a clinical trial of NTLA-2002. Prospective Patients: Ready to get started? Enroll to get your medications from CVS Specialty. , Berinert®, Ruconest®, Kalbitor®); Request does not exceed 6 doses per month; FIRAZYR prescription and dosage information for physicians and health care professionals. Dec 4, 2020 · Icatibant injection, a generic form of Firazyr from Fresenius Kabi, is now available to adults in the United States for the treatment of acute attacks of hereditary angioedema (HAE), the company announced. Aug 16, 2023 · The US Food and Drug Administration (FDA) has approved a new generic icatibant injection for the treatment of acute hereditary angioedema swelling attacks. If the patient meets the standard Hereditary Angioedema – Icatibant Prior Authorization Policy criteria but has not tried the Preferred Product, approval for the Preferred Products will be authorized. For practical information about using Firazyr, patients should read the package leaflet or contact their doctor or pharmacist. Fresenius Kabi’s generic option uses the same active ingredient as Firazyr®*, has the same intended use, and is also administered subcutaneously. Mar 12, 2025 · Find patient medical information for Icatibant (Firazyr, Sajazir) on WebMD including its uses, side effects and safety, interactions, pictures, warnings, and user ratings SAJAZIR is an FDA-approved injection indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults aged 18 years and older. Generic version of Firazyr is prescribed, unless medical justification supports inability to use the generic (e. 1 As you never know when your next hereditary angioedema attack might be, each SAJAZIR single-dose syringe comes pre-filled and ready to go. Site of administration? Information on FIRAZYR subcutaneous injection 30mg syringe from Takeda Pharmaceutical Company Limited online, Ministry of Health and Welfare Code is 4490406G1029, packaging is 1 syringe × 1 syringe = 1 syringe 1 syringe × 3 syringe = 3 syringe, Information was updated on Oct. Learn about efficacy and safety data in trials and what the symptoms reduction looks like. It is protected by 1 US drug patent filed in 2013 out of which all have expired. S. Below brand-name products are in CAPS, and generic products are shown in lowercase italics. Discover more about Firazyr including its uses, side effects, doses, images, and alternative medications. During the same period, Sandoz launched its version of Firazyr. This Marks Glenmark'S First Synthetic Decapeptide Injectable This list is updated quarterly. Q4: How is FIRAZYR administered? Save 80% on FIRAZYR with coupons, patient assistance programs, Canadian prescription savings, and Rx savings cards at CVS, Walgreens, and local pharmacies. May 24, 2021 · The medication is the generic of Shire Human Genetic Therapies’ Firazyr. Learn more about FIRAZYR® (icatibant injection). The safety of self-administration was evaluated in a separate, open-label trial in 56 patients with HAE. , Berinert®, Ruconest®, Kalbitor®); Mar 15, 2023 · Icatibant (generic for Firazyr), Sajazir (generic for Firazyr) and brand Firazyr specific criteria Must have a diagnosis of acute attacks associated with hereditary angioedema (progress notes required) Must be used for acute episodic attacks--Safety and efficacy as prophylactic therapy has not been established and therefore will not be covered Feb 2, 2021 · Sandoz has signed a U. Firazyr is a drug owned by Takeda Pharmaceuticals Usa Inc. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name and works the same way in the body in the same amount of time. An authorized generic is used to describe an approved brand name drug FIRAZYR® (icatibant injection) is the registered name (also known as the “brand name”) for the treatment that is manufactured by Takeda and was approved by the FDA in 2011. Q2: Who manufactures FIRAZYR? A: FIRAZYR is manufactured by Shire Orphan Therapies, Inc. All approvals are for 1 year in duration, unless otherwise noted below. Mar 26, 2021 · In early 2021, Teva Pharmaceuticals announced the US launch of generic versions of NuvaRing® and AZOPT®. This list of authorized generic drugs (AGs) was created from a manual review of FDA’s database of annual reports submitted to the FDA since January 1, 1999 by sponsors of new drug applications Limited distribution drug How to get this medication generic Firazyr is a specialty medication, which means it's costly and requires more steps than usual in order to get it. Adalvo believes it is in the first wave of applicants to submit its filing within the European Union. The FDA ensures a generic medication provides the same clinical benefit and is as safe and effective as the brand-name medicine that it duplicates. In this trial, the safety profile of FIRAZYR in patients who self-administered FIRAZYR was similar in nature and frequency to that of patients whose therapy was administered by healthcare professionals. Compare prices and print coupons for Icatibant and other drugs at CVS, Walgreens, and other pharmacies. Aug 25, 2011 · Firazyr FDA Approval History FDA Approved: Yes (First approved August 25, 2011) Brand name: Firazyr Generic name: icatibant Dosage form: Injection Company: Shire plc Treatment for: Angioedema Firazyr (icatibant) is a selective B2 bradykinin receptor antagonist indicated for the treatment of acute attacks of hereditary angioedema. The SBD for Firazyr is located below. Brand name FIRAZYR will continue to be available. Includes Firazyr dosing information, clinical trials, and side effects. Firazyr works by blocking the binding of bradykinin to the bradykinin B2 receptor Overview Firazyr is a drug product by TAKEDA CANADA INC, authorized by Health Canada. Pay as little as $0* for Teva's generic version of Firazyr® (icatibant injection) *Commercially insured patients may pay as little as $0 out of pocket for Teva’s Icatibant Injection. Prasco Authorized Generics are made by the original brand manufacturers, often in the same facilities, and carry the legacy of years of research, manufacturing excellence and high quality production that comes Jan 7, 2025 · Uses Firazyr is a bradykinin B2 receptor antagonist used to treat acute episodes of swelling and inflammation associated with hereditary angioedema (HAE). Administration, cost, adverse reactions, special populations, & more. They should be trained in subcutaneous injection techniques by a healthcare professional before they can administer FIRAZYR. Last updated on Oct 28, 2025. Stay informed on drug availability and coverage updates. If request is for brand Firazyr, member must use generic icatibant, unless contraindicated or clinically significant adverse effects are experienced; Member is not using Firazyr in combination with another FDA-approved product for treatment of acute HAE attacks (e. Nonclinical studies administering FIRAZYR at a high-frequency of high doses in rats and dogs, in which FIRAZYR was administered on a daily basis for 7 and 13 weeks, respectively, demonstrated treatment-related, reversible impairm If request is for brand Firazyr, member must use generic icatibant, unless contraindicated or clinically significant adverse effects are experienced; Member is not using Firazyr in combination with another FDA-approved product for treatment of acute HAE attacks (e. How it works Firazyr is used to treat attacks of hereditary angioedema (HAE) in adults. Applies to: Icatibant Number of uses: Per prescription until program expires Expires December 31, 2025 Form more information phone: 844-248-7949 or Visit Firazyr is a medication prescribed for the treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents, and children Oct 10, 2025 · Following the expiration of its patent in July 2019, generic versions of Firazyr (icatibant injection) became available in the United States. May 25, 2021 · Glenmark Pharmaceuticals Limited Has Received Final Approval By The United States Food &Amp; Drug Administration (Fda) For Icatibant Injection, 30 Mg/3 Ml (10 Mg/Ml) Single-Dose Prefilled Syringe, The Generic Version Of Firazyr Injection, 30 Mg/3 Ml (10 Mg/Ml) Single-Dose Prefilled Syringe, Of Shire Human Genetic Therapies, Inc. Jun 30, 2025 · Firazyr is used for hereditary angioedema (HAE) to treat acute HAE attacks in adults 18 years and older. View Important Safety Information for warnings and precautions. Investigated for use/treatment in angioedema, liver disease, and burns and burn infections. The primary component is Icatibant Acetate. Instant, side-by-side breakdown of Firazyr vs Sajazir. Oct 10, 2025 · Yes, generic versions of Icatibant acetate are available in the U. Learn how to lower long-term costs, and more. Approved for use in acute attacks of hereditary angioedema (HAE). Reauthorization: Authorization of an additional 6 months may be granted to members requesting authorization for continuation of therapy and were previously authorized by HMSA/CVS and who meet all of the following criteria:who are benefitting from icatibant therapy and were previously authorized by HMSA/CVS. , contraindications to excipients in the generic); Member is not using Firazyr in combination with another FDA-approved product for treatment of acute HAE attacks (e. Dec 15, 2021 · Learn about icatibant (Firazyr) usage and dosing. We break down the process for you. The patent for FIRAZYR® (icatibant injection) expires on July 15, 2019. . The cost of Sajazir Jan 23, 2025 · Firazyr (icatibant) is the first FDA-approved drug given subcutaneously to treat hereditary angioedema. 21, 2025. Food and Drug Administration has approved a new generic version of Firazyr (icatibant injection) for hereditary angioedema (HAE). Learn about FIRAZYR® (icatibant injection), a portable acute therapy option for adults 18 years of age and older living with hereditary angioedema (HAE). At Takeda, our ongoing commitment leading up to the patent expiration for FIRAZYR includes the following: •Continued manufacturing and availability of Pharmacy Update - Notice of Changes to Prior Authorization Requirements and Coverage Criteria for UnitedHealthcare Commercial Feb 14, 2024 · Firazyr is an under-the-skin injection therapy approved for on-demand management of swelling attacks in hereditary angioedema (HAE) patients. NDC 54092-135 Icatibant Icatibant Icatibant is a Subcutaneous Injection, Solution in the Human Prescription Drug category. Berinert, icatibant (generic, Firazyr, Sajazir), Kalbitor (ecallantide), and Ruconest are FDA-approved for the on-demand treatment of HAE attacks. Firazyr was approved by the US Food and Drug Administration (FDA) in August 2011. Icatibant injection is indicated for the treatment of acute attacks of HAE in adults 18 years of Cipla’s Icatibant Injectable Pre-Filled Syringe 30mg/3mL is AP-rated generic version of Shire’s Firazyr®. How it works Upsides Downsides Bottom Line Tips Response/effectiveness Interactions FAQ 1. See PI and full safety information. 1 It was developed by Shire, now part of Takeda Pharmaceuticals, and is now produced and distributed by Takeda. Oct 28, 2025 · Firazyr Patient Tips Medically reviewed by Carmen Pope, BPharm. Sep 29, 2020 · The FDA approved Cipla’s dimethyl fumarate capsules, at 120 mg and 240 mg, as a lower cost and bioequivalent generic version of Tecfidera. The original therapy was developed by Shire, now part of Takeda. Firazyr is a brand name of icatibant, approved by the FDA in the following formulation: Cipla’s Icatibant Injectable Pre-Filled Syringe 30mg/3mL is AP-rated generic version of Shire’s Firazyr®. Learn about generic options for the brand-name drug Firazyr, including cost and effectiveness for HAE. Summary Basis of Decision (SBD) documents provide information related to the original authorization of a product. Save money on your Firazyr® prescription by switching to Teva's FDA-approved generic version, Icatibant Injection Brand vs. Jul 8, 2025 · Detailed dosage guidelines and administration information for Firazyr (icatibant acetate). The brand-name version of this drug is Firazyr. Who is administering this medication? Self-administration Health Care Professional 4. Firazyr may be given up to 3 times in 24 hours during an acute attack. It is use d to treat acute attacks of hereditary angioedema in adults 18 years of age and older. Page 1 of 3 - Cigna National Formulary Coverage - Policy: Generic version of Firazyr is prescribed, unless medical justification supports inability to use the generic (e. Generic icatibant is a treatment that may become available after the patent for FIRAZYR expires and may be made by a number of diferent companies. Brand product (Berinert, Ruconest, Kalbitor, Firazyr) Generic product (Icatibant: generic Firazyr) Sajazir 3. Drug Information May 27, 2021 · The FDA has approved a new generic version of Firazyr (icatibant injection), made by Glenmark Pharmaceuticals, to treat hereditary angioedema attacks. Feb 12, 2025 · Icatibant (Firazyr) is a generic drug prescribed for hereditary angioedema in adults. | ICATIBANT (eye KAT i bant) treats attacks of hereditary angioedema (HAE). [5][3][4] It is not effective in angioedema caused by medication from the ACE inhibitor class. Dec 18, 2009 · Firazyr ® (icatibant) is a bradykinin B2 receptor antagonist that is used in the treatment of acute attacks of hereditary angioedema (HAE) in adults aged 18 and over. Icatibant is the active ingredient in FIRAZYR. Details of Firazyr's patents and their expiration are given in the table below. Feb 23, 2024 · Sajazir is a branded-generic medication that’s prescribed for swelling attacks in people with hereditary angioedema (HAE). 12 Aug 17, 2023 · The U. The drug is indicated for the treatment of Hereditary Angioedema (HAE). 1 Sep 30, 2021 · The FDA last year approved Cipla’s generic version of Firazyr — which was first approved in 2011 for treating acute HAE attacks in patients ages 18 and older. Food and Drug Administration Sensible and Effective HAE Treatment Options Generic medications go through a rigorous review process to receive FDA approval. Firazyr can be used alone or with other medications, depending on the patient’s condition and disease. The FDA List of Authorized Generics page answers what an authorized generic is and how it differs from a traditional generic. Cipla’s Icatibant Injectable Pre-Filled Syringe 30mg/3mL is AP-rated generic version of Shire’s Firazyr. However, unlike other on-demand treatment options, the effectiveness of Ruconest for the treatment of laryngeal attacks has not been established. It is a brand name for icatibant. It is given as a single subcutaneous (under the skin) injection. , Berinert®, Ruconest®, Kalbitor®); Request does not exceed 6 doses per month; Jul 23, 2020 · Alvogen’s newly created B2B unit, Adalvo, has filed for a generic version of Takeda’s Firazyr with the EMA to enhace its peptide portfolio, which currently includes several products focused on rare diseases and diabetes. Nov 8, 2013 · Firazyr - Get up-to-date information on Firazyr side effects, uses, dosage, overdose, pregnancy, alcohol and more. Compare Berinert vs Firazyr head-to-head with other drugs for uses, ratings, cost, side effects and interactions. Jan 4, 2024 · The new generic, made and marketed by Eugia Pharma Specialities, a subsidiary of Aurobindo Pharma, joins several other generic versions of Firazyr authorized in the U. Learn more about Firazyr Jun 11, 2024 · Firazyr is a prescription drug used to treat hereditary angioedema attacks. Includes dose adjustments, warnings and precautions. Firazyr is also used to associated treatment for these conditions: ACE Inhibitor Jul 15, 2020 · Cipla has received final approval from the U. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 25, 2018. 1,2 HAE is an uncommon condition Icatibant, sold under the brand name Firazyr, is a medication for the symptomatic treatment of acute attacks of hereditary angioedema (HAE) in adults with C1-esterase-inhibitor deficiency. These generic alternatives offer patients with Hereditary Angioedema (HAE) the potential for cost savings while providing the same active ingredient and therapeutic effect as the brand-name medication. , Berinert®, Ruconest®, Kalbitor®); The safety of self-administration was evaluated in a separate, open-label trial in 56 patients with HAE. Last updated on Feb 27, 2025. , Berinert®, Ruconest®, Kalbitor®); A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, how it is taken, performance, and intended use. Sajazir or Firazyr Savings, Coupons and Information. Learn about its cost, dosage, side effects, uses, how it works, and more. usiempx vlnrmy xiwsh itfek qbfwj tdp dcdtj jtsrjgd ukexm vnuz quz yhpv rdnvpdo jccvt pwyxji