Thread by @VikasReports

#Thread: As @Novartis’ vildagliptin (#Galvus) goes off-patent in #India today and a scramble is expected, some tidbits about this hugely successful drug.
-Vildagliptin, from a class of drugs called DPP-4, was launched in India in 2008 with a licensing arrangement with USV (1)

-This was one of the first few drugs launched post-2005, the starting of India's product patent era
-Novartis’ drug is Galvus and USV took the brand name Jalra; Novartis marketed Galvus in top cities while USV sold in smaller cities as Jalra (2)

-There was ample space for new anti-diabetes therapies and move the market beyond metformin and sulphonyureas
-GSK had a setback after Avandia (thiazolidenediones or TZD) was found to have safety issues. Curiously, a few years later, the drug was cleared by the US FDA (3)

-Interestingly, Dan Vasella, the then charismatic CEO at Novartis, decided against launching vildagliptin in the US
-US FDA had sought additional safety studies for approval but since Novartis had secured the European approval in 2007, it stayed out of the US (4)

-Known for big blockbusters, Merck, MSD in India, launched Januvia (sitagliptin) slightly ahead, so Novartis priced its tablet a tad lower, at around Rs 38-39 against Rs 42 of Januvia
-Between Janvia and Galvus + Jalra, it was a heady, neck and neck fight for market share (5)

-Novartis later licensed the drug to Piramal, under brand Zomelis (it went to Abbott and trademark sold recently to Eris)
-Novartis and MSD launched innovative disease management programs first time in India adding a lot more to patient care beyond just selling pills (6)

-Interestingly, a minimum of 10 drug makers filed for approvals of vildagliptin but Novartis blocked those via aggressive lawsuits
-Other DPP-4s like linagliptin and saxagliptin also came; Saxagliptin saw a CL bid after Bayer’s Nexavar, but it was shot down (7)

-While MSD’s Januvia ramped up its lead for a few years, Galvus + Jalra zipped past, forcing Merck to license sitagliptin to Sun Pharma in 2011; Istamet and Istavel were aimed to halt the march of several Galvus cousins (8)

-Cipla, Emcure also teamed up with Novartis; Cipla’s deal was widely seen as a departure from its strident anti-MNC posture but it said its philosophy was only against drug monopolies.
(9)

All DPP-4 brands built strengths to reshape the Indian oral anti-diabetes market beyond metformin and sulphonylureas; Amid all this, Glenmark did something audacious; it launched a copy of Merck’s Januvia and made a few cool crores before it lost a case against MSD in 2015(10)

As vildagliptin patent expires today, 20 to 50 companies are raring to capture the opportunity.
The prices of the branded generics may crash to Rs 6 per tab; huge affordability for patients (11)

-Drug makers USV and Eris paid big money to Novartis for the licenses in the belief that they can further bolster their presence; appears if the drug is locally produced, the margins may be good. (12)

-On ways to induce the doctors for their brands, some marketing sources say doctors have been promised Rs 1 lakh a month, if they generate xyz number of prescriptions. (13)

-And there is much more to unfold. Teneligliptins will see big rivals as vildagliptin is believed to have better safety data.
-Question: Will Novartis, other DPP-4 players cut their brand prices? How will SGLT2s be impacted?
(14)