Rush to apply for generic marketing authorization…"indication splitting"

Neutralizing the extended enforcement period of the original brand's core patent for its substance patent, in addition to avoiding the crystalline form patent

If this strategy is successful, the launch date will move from 2032 to 2030

Have filed for three indications, including rheumatoid arthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease, out of six indications of the original drug

AbbVies Rinvoq Extended-Release tablets

Korean pharmaceutical companies are splitting implications to launch generics of AbbVie Korea’s blockbuster autoimmune treatment, Rinvoq (upadacitinib) Extended-Release tablets. This strategy is to partially neutralize the extended enforcement period of the original brand's core patent for its substance. If this strategy succeeds, the launch timeline for these generic versions could be accelerated by two years, from May 2032 to December 2030.  

According to industry sources on June 15, multiple pharmaceutical companies submitted marketing authorization applications for upadacitinib formulations to the Ministry of Food and Drug Safety (MFDS) on June 4. The filings were scheduled on the immediate day following the June 3 expiration of Rinvoq’s data protection (re-examination) window.

According to the tracking data disclosed by the MFDS, unlike the multi-indicated original brand, these developers applied for marketing authorization of three indications: ▲atopic dermatitis ▲ulcerative colitis ▲Crohn's disease. This strategy directly aligns with the legal rationale underpinning ongoing patent trials challenging the extension of the substance patent duration. By narrowing their focus to the highly marketable fields of atopic dermatitis and inflammatory bowel disease (IBD), the generic companies intend to challenge the unextended patent window.

If the generic companies secure a favorable final ruling on their patent circumvention claims, they would launch their products as early as December 1, 2030. This move would bring the market entry timeline forward by approximately 18 months ahead of the extended substance patent’s expiration date in May 2032.

In March of this year, the Intellectual Property Trial and Appeal Board (IPTAB) ruled in favor of 16 domestic pharmaceutical companies, including Daewoong Pharmaceutical, Samjin Pharmaceutical, Chong Kun Dang, Huons, Dong-A ST, Ildong Pharmaceutical, and GC Biopharma, in a negative scope-of-confirmation trial targeting Rinvoq's crystalline form patent, which is set to expire on October 17, 2036.

These companies had previously filed their initial trial petitions between August 19 and September 2 of last year, successfully satisfying a key administrative prerequisite to secure Priority Marketing Authorization rights. Consequently, the most prolonged patent wall blocking market entry until 2036 has been dismantled.  

After that, the challenge shifted to the primary substance patent, which is protected through May 16, 2032. Initiated by Dongkoo Bio & Pharma, as well as 12 other companies, including Daewoong Pharmaceutical and Samjin Pharmaceutical, filed trial petitions between April 30 and May 14 to contest the regulatory extension of the substance patent's term.

This strategy aims for an "indication splitting". While Rinvoq currently has six approved clinical indications, including rheumatoid arthritis, atopic dermatitis, ulcerative colitis, and Crohn's disease, the generic companies argue that although the originator secured a term extension due to regulatory review delays, the enforcement of this extension should apply exclusively to rheumatoid arthritis, the target indication of the initial clinical trials.  

If this succeeds, generics could lawfully launch for the remaining indications immediately following December 1, 2030, which marks the baseline expiration date of the substance patent before its regulatory extension. 

In addition to legal debate, companies are filing applications for marketing authorization.

A pharmaceutical industry insider said, "Now, the strategy of domestic firms to select highly competitive indications like atopic dermatitis and IBD for an expedited commercial launch is being realized rapidly," and added, "MFDS's approval and IPTAB’s upcoming rulings on the substance patent extension will serve as a market shifter, shifting the competitive landscape of the domestic autoimmune market."

According to UBIST data, Rinvoq generated approximately KRW 36.2 billion in domestic outpatient prescription sales last year.