When did FIRAZYR go generic? The Timeline of Icatibant's Market Entry

October 9, 2025 •

3 min read

On July 15, 2019, the patent for the brand-name drug FIRAZYR (icatibant injection) officially expired in the United States, which paved the way for generic versions. The answer to the question, 'When did FIRAZYR go generic?' is not a single date but a series of launches that began shortly after its patent lapsed.

Quick Summary

FIRAZYR's patent expired on July 15, 2019, enabling generic icatibant injections to enter the US market. The first generic options became available soon after, with major launches by manufacturers like Cipla, Fresenius Kabi, Sandoz, and Eugia Pharma occurring between 2020 and 2023.

Key Points

Patent Expiration Date: The patent for brand-name FIRAZYR expired on July 15, 2019, which opened the door for generic competition.
Initial Generic Availability: Generic versions of icatibant began receiving FDA approval and entering the US market shortly after the patent expired.
Sandoz's Major Launch: Sandoz, a key generic manufacturer, announced its US launch of generic icatibant on January 28, 2021, following FDA approval in September 2020.
Multiple Manufacturers: The generic market expanded over several years, with additional approvals and launches from companies like Cipla, Fresenius Kabi, and Eugia Pharma.
Cost Reduction: The availability of generic icatibant has increased market competition, typically leading to lower costs for patients compared to the brand-name drug.
Bioequivalent Efficacy: Generic icatibant contains the same active ingredient and is considered as safe and effective as brand-name FIRAZYR for treating HAE attacks.

Understanding FIRAZYR and Its Patent

FIRAZYR, with the active ingredient icatibant, was originally developed to treat acute attacks of hereditary angioedema (HAE) in adults. HAE is a rare genetic disorder characterized by severe, localized swelling. As with most brand-name medications, FIRAZYR was protected by a patent that gave its manufacturer, Takeda (formerly Shire), exclusive rights to market the drug for a period. This exclusivity allows a company to recoup the significant research and development costs required for drug development.

The patent for FIRAZYR (icatibant injection) in the United States expired on July 15, 2019. This date is the critical moment when other pharmaceutical companies could legally bring their own generic versions of icatibant to market, pending approval from the U.S. Food and Drug Administration (FDA).

The Timeline of Icatibant Generic Approvals and Launches

Following the patent expiration, the market saw a wave of FDA approvals for generic icatibant from various manufacturers. The introduction of these generics significantly increased competition and provided patients with more affordable options for managing HAE attacks.

Notable Generic Icatibant Launches

July 15, 2019: Teva Pharmaceuticals USA had an approved generic version on this date, coinciding with the patent's expiration.
Early-to-Mid 2020: Companies like Cipla and Fresenius Kabi received FDA approval and launched their generic versions of icatibant injections.
Late 2020: Jiangsu Hansoh Pharma and Nang Kuang Pharm Co also received FDA approvals, further expanding the generic supply.
January 28, 2021: Sandoz, a global leader in generic and biosimilar medicines, announced the US launch of its generic icatibant injection. This launch was a significant event, widely publicized via PR Newswire.
August 2023: Eugia Pharma, a subsidiary of Aurobindo Pharma, announced the FDA approval and launch of a new generic version of icatibant, adding another competitor to the market.

Generic vs. Brand-Name Medications: Key Differences

While brand-name drugs like FIRAZYR are often the first to market, generic versions, such as icatibant injection, offer a cost-effective and equally effective alternative. Here is a quick comparison:


Aspect	Brand-Name (FIRAZYR)	Generic (Icatibant)
Active Ingredient	Icatibant (as icatibant acetate)	Icatibant (as icatibant acetate)
Efficacy & Safety	Tested and approved for safety and efficacy.	Considered to be bioequivalent and equally effective.
Cost	Typically higher priced due to initial R&D costs.	Significantly lower in cost due to market competition.
Appearance	Distinct packaging and labeling.	May differ in appearance (e.g., color, shape) but not formulation.
Formulation	Proprietary formulation.	Identical active ingredient; inert ingredients can differ.

The Impact of Generic Icatibant on Patients

For patients with hereditary angioedema, the availability of generic icatibant is a major benefit. Before generics, patients and their insurance providers were limited to covering the high cost of the brand-name product. The introduction of multiple generic options has spurred competition, which can drive down overall costs for both patients and healthcare systems. This can translate to lower co-pays for insured patients and more affordable treatment for those paying out-of-pocket.

Furthermore, generic availability helps ensure a stable supply chain, potentially reducing the risk of shortages. As a treatment for acute HAE attacks, consistent and reliable access to medication is vital for patients' safety and well-being.

Key Generic Launches:

Teva Pharmaceuticals (July 2019)
Cipla (2020)
Fresenius Kabi (2020)
Sandoz (January 2021)
Eugia Pharma (August 2023)

Conclusion: Increased Access and Affordability

In summary, while the patent for FIRAZYR expired on July 15, 2019, the entry of generic icatibant into the market was a staggered process, beginning with the first approvals shortly after that date. The full impact of generic competition was felt as multiple manufacturers, including Teva, Cipla, Fresenius Kabi, Sandoz, and Eugia Pharma, secured FDA approval and launched their versions over the following years. This timeline of generic market entry has had a profoundly positive effect, offering increased access, competition, and affordability for HAE patients who rely on icatibant to manage their acute attacks.

For more information on the generic alternative, you can refer to an article on Medical News Today discussing icatibant injection.

Frequently Asked Questions

Yes, generic icatibant is considered to be just as safe and effective as brand-name FIRAZYR. The FDA requires generic drugs to contain the exact same active ingredient and function identically to their brand-name counterparts.

Most insurance plans cover generic medications, often at a lower co-pay than brand-name drugs. However, coverage can vary, so it is best to check with your insurance provider to understand your specific benefits.

FIRAZYR is the brand name, while icatibant is the active ingredient and generic name. Both drugs are used to treat acute HAE attacks in adults and are medically equivalent.

Generic versions of medications are typically less expensive than brand-name drugs due to market competition. The exact savings depend on your insurance, pharmacy, and the specific generic manufacturer.

Several companies manufacture generic icatibant, including Sandoz, Teva Pharmaceuticals, Cipla, Fresenius Kabi, and Eugia Pharma, among others.

If you are interested in switching to generic icatibant, you should talk to your doctor. They can help you with the prescription and discuss any potential changes, though the medications are bioequivalent.

Because generic icatibant is the same active ingredient as FIRAZYR, it has a similar side effect profile, which can include injection site reactions, nausea, dizziness, and headache.