Sanofi’s Allegra dominates OTC·ETC drug market

…chased by Hanmi Pharmaceutical

Fexofenadine 120mg dose accounts for over 60% of the OTC market

Original drug shows strength in the ETC market as well… its generic Fexonadine make ₩1 billion externally

The market for OTCs and ETCs of the antihistamine ingredient fexofenadine hydrochloride has been showing stagnant performance with its sales making a rectangle pattern for several years now.

 

The market is virtually monopolized by the original drug, Sanofi’s Allegra Tab., with the total market estimated to be in the ₩8 billion range.

 

One aspect to note is that the high-dose 120mg Allegra Tab.

 

is listed for reimbursement as an OTC, and the other 180·60·30mg strengths of Allegra are distributed and prescribed as ETCs in Korea.

 

This is analyzed as a strategic decision made by the company in consideration of the clinical protocol, design, and efficacy of its drug.

 

Allegra is in the undisputed lead among fexofenadine hydrochloride OTCs, showing a vendor performance of ₩2-3 billion.

 

Hanmi Pharmaceutical's Fexonadine, Huon’s Allerdin, and Chong Kun Dang’s Pecsone 120mg had sold ₩350 million, ₩150 million, and 120 million each, respectively.

 

These latecomers were all released around 2005 and 2008, and all three drugs are all listed at ₩226 per tablet.

 

The price of Sanofi’s finished imported pharmaceutical, the OTC Allegra, has been discounted to ₩225/tablet in 2017, ₩224/tablet in 2018, then to ₩222 in 2022, and is currently sold at a lower price than its domestic latecomers.

 

Allegra and other OTC drugs with identical APIs that are effective in alleviating symptoms of allergic rhinitis are recommended to be administered with caution in patients with kidney failure, cardiovascular disease, or old age, and require particular medication guidance on the pharmacist’s part.

 

In addition, its related ingredients are classified as pregnancy risk category C, and are used when there is a clear clinical basis or reason for its inevitable use.

 

In the fexofenadine hydrochloride ETC market, the original, Sanofi’s Allegra and its bioequivalent, Hanmi Pharmaceutical’s Fexonadine are in a two-way battle.

 

Allegra 180mg sold ₩3.1 billion, Fexonadine 180mg ₩870 million last year, and Allegra 30mg ₩240 million, Fexonadine 30mg ₩140 million.

 

The 180mg strength of Allegra that was approved in 2000 is used to treat allergic dermatitis, and its price had been reduced to ₩314/tablet in 2017, ₩313/tablet in 2018, ₩312/tablet in 2020, and then to ₩311/tablet in 2022.

 

The price of Allegra 60mg is currently set at ₩181/tablet and is effective in relieving symptoms of seasonal allergic rhinitis.

 

According to the insert paper, etc.

 

patients with hypertension, diabetic kidney disease, hyperthyroidism, and benign prostatic hyperplasia are requested to consult with their doctor, dentist, or pharmacist before taking the drug.

 

Allegra 30mg, which is priced at ₩91/tablet, is prescribed to relieve symptoms of seasonal allergic rhinitis and allergic dermatitis.

 

Hanmi Pharmaceutical’s Fexonadine 30mg, which was approved as a bioequivalence-assured product in 2007 is listed at ₩91/tablet, at the same price as the original drug.

 

Meanwhile, one point of interest is in their distribution.

 

The distribution of Allegra is dualized so that the OTCs are directly managed by Sanofi while the ETCs are imported and sold by Handok Pharmaceuticals.