Gen­er­ics eye ₹5,000-cr sema­glu­tide mar­ket des­pite export hurdles

At least 15 drug­makers are in the fray to tap the estim­ated ₹5,000 crore oppor­tun­ity emer­ging from sema­glu­tide’s pat­ent expiry, but the road to for­eign mar­kets is fraught with reg­u­lat­ory hurdles, say experts.
“Pat­ent expiry of sema­glu­tide in India, emer­ging mar­kets (EM) and reg­u­lated mar­kets (Brazil, Canada) could cre­ate an incre­mental ₹50 billion plus rev­enue oppor­tun­ity for gen­eric ver­sions over the next 12-15 months,” said a recent report from the Sys­tem­atix Group.
In India, a com­pound pat­ent on sema­glu­tide expires in March 2026, and the oppor­tun­it­ies are going to be from India and the emer­ging markets, Vishal Man­chanda,
Senior Vice-Pres­id­ent (Insti­tu­tional Research) with Sys­tem­atix Group told busi­ness­line.
In reg­u­lated developed mar­kets, approvals gen­er­ally take more time, he said, and they are “cau­tious” about approv­ing pep­tides.
“His­tory says that there are not too many pep­tide gen­er­ics avail­able in Canada or Brazil.”
MAIN INGREDIENT Sema­glu­tide, a glu­ca­gon-like pep­tide-1 (GLP-1) ana­logue from Novo Nor­d­isk, is the main ingredi­ent in inject­able weight loss and dia­betes drugs Wegovy and Ozempic, respect­ively, besides Rybelsus (oral pill), for adults with type 2 dia­betes.
Canada is open from Janu­ary for gen­eric drug­makers to make sema­glu­tide, and for­eign media reports indic­ate
more than a hand­ful sub­mis­sions have been received to make it from Apo­tex, Teva Pharma and Aspen, among oth­ers.
REGULATORY HURDLES
Dr Reddy’s Labor­at­or­ies (DRL), among the first o¨the-blocks from India, had approached the local courts to be allowed to export.
In Decem­ber 2025, the Delhi High Court allowed DRL to export to regions that did not have a pat­ent on this drug.
However, the drug­maker now awaits a reg­u­lat­ory green­light to sell in Canada.
Last month also saw Sun Pharma com­mit­ted to the Delhi High Court that it would not sell in India, till Novo Nor­d­isk’s pat­ent on sema­glutide expires in the coun­try. It is, however, allowed to man­u­fac­ture and export. Intel­lec­tual prop­erty expert Rajesh­warie Hari­haran explains, com­pan­ies have been allowed to export small quant­it­ies to seek reg­u­lat­ory approvals; not for com­mer­cial sale.
Mean­while, in a sig­ni­fic­ant devel­op­ment on Decem­ber 31 2025, Novo Nor­d­isk said, the Supreme People’s Court in China had ruled in its favour “on the intel­lec­tual prop­erty rights relat­ing to the sema­glu­tide com­pound pat­ent.” Giv­ing details, the Dan­ish health­care com­pany said, “the Court has upheld the Beijing IP Court rul­ing recog­nising the valid­ity of the sema­glu­tide com­pound pat­ent.”
Novo Nor­d­isk, however added, the latest rul­ing would not alter its earlier pos­i­tion — that the com­pound pat­ent expiry of the sema­glu­tide molecule in cer­tain coun­tries would have a neg­at­ive low-single-digit impact on global sales growth in 2026.
REVENUE PROJECTIONS
On sema­glu­tide pro­jec­tions, the Sys­tem­atix report said, “For FY27E, we see this as a ₹10-₹20 bil­lion incre­mental rev­enue oppor­tun­ity in India branded for­mu­la­tion space, about ₹45 bil­lion in reg­u­lated mar­kets (Canada and Brazil) and ₹5 bil­lion-₹10 bil­lion for emer­ging mar­kets (EM).
“The reg­u­lated mar­kets oppor­tun­ity can be large in the near term, but should gradu­ally sub­side over time. In addi­tion, there are also mean­ing­ful risks — reg­u­lat­ory and com­mer­cial risks. India and EM oppor­tun­ity may not become as large immin­ently, but will keep expand­ing over years. The reg­u­lat­ory risks are also lower in India and EM.”
Source : Pressreader