Rx and market share trends for key US products: IIFL Capital Services

22 Jun 2023 , 12:24 PM

Key takeaways include:

• During April-May 2023, Zydus loses MS in Trokendi XR as competition launched their products. Per latest IU volumes, MS of Zydus declined to 26% in May 2023 from 40% in Mar 2023.
• Analysts at IIFL Capital Services estimate market size of Chantix to be around USD300-320mn and per latest IU volumes, Endo and Apotex have ~87/13% MS in April-May 2023. Zydus has recently got the approval and analysts at IIFL Capital Services believe it can garner 12-15% MS with 40% price erosion.
• Lupin and Teva has launched their generic versions of Prezista in the market in June 2023. Lupin has 180-day exclusivity on 800mg, while it shares the same with Teva for 600mg strength.
• Sun’s Ilumya IU volumes clocked 16% sequential growth during April-May 2023. Cequa’s IU volume grew 9% sequentially and up 35% YoY in April-May 2023. Winlevi’s monthly TRx volumes of 35.3K in May 2023 is slightly higher than FY23 monthly run-rate of 34.5K.
• Even after escalation of non-compliance action on Mohali plant, Sun has been able to gain MS in Pentasa, given the absence of incremental generic competition. Sun’s MS stood at ~58% during April-May 2023.
• Sun has regained some MS in Ambisome and captured ~8% in May 2023, as the innovator ceded MS. Aurobindo’s MS is stable at ~8% in May 2023.
• Biocon’s MS in Insulin Glargine is stable at ~13% while it gained MS in Trastuzumab and Pegfilgrastim and its MS stood at ~10/15.5% respectively during April-May 2023.

 

Revlimid – Innovator’s MS further moderated to ~53% with 9 generic launches till May 2023; sharp uptick in Teva/Natco volumes

Interestingly, Teva/Natco’s MS in gRevlimid per integrated units (IU) has improved to ~13% in May 2023, after sustaining at 7-10% over the past 7 months. Dr. Reddy’s improved its MS from ~3.6% in Q4FY23 to 5.7% in May 2023. On the other hand, Cipla’s MS has reduced from ~10% in March 2023 to 6% in May 2023. Hetero Pharma is the new generic entrant and has negligible MS in May 2023. Zydus Life continues to maintain MS in the mid-teens and garnered ~15% MS in May 2023. Per Symphony data, after launching gRevlimid in March 2023, Sun Pharma captured ~3% MS in May 2023. Next leg of generic launches for Revlimid will likely be from Aurobindo, Lupin, Torrent, Alembic and Alkem over next 6-18 months.

 

Ilumya – IU volumes are up 16% sequentially for April-May 2023 

Per Symphony data, Ilumya’s integrated unit (IU) volumes are up 16% sequentially for April-May 2023. Due to better compliance, cost competitiveness and dosing convenience of Ilumya, analysts at IIFL Capital Services believe the robust traction will continue despite strong competition from big Pharma companies in the US in Psoriasis drugs. Ilumya’s global revenue will probably grow at ~13% CAGR from USD440mn in FY23 to USD630mn in FY26. Growth can potentially be aided by Psoriatic Arthritis indication (in P-3 clinical trials currently – likely approval in FY25, per IIFL estimates).

Cequa – Sun’s MS is stable in Dry Eye Ophthalmic products, despite generic competition in Restasis

Per Symphony data, in April-May 2023, Cequa’s TRx volumes are up 2% sequentially and up 23% YoY while Cequa’s IU volumes were up 9% sequentially and up 35% YoY. In the overall Dry Eye Ophthalmic market, Cequa’s MS marginally improved to 4.4% in April-May 2023 versus 4.3% in Q4FY23. Apotex/Mylan/KVK Tech/Lupin (Restasis generic/AG players) have lost 160bps MS in April-May 2023 versus Q4FY23 while Allergan (Restasis) gained 80bps MS over the same period. Novartis (Xiidra) MS also improved to 24.3% in April-May 2023, which was <24% over the past 5 months. Despite generic competition in Restasis, Sun has exhibited robust growth in Cequa. Analysts at IIFL Capital Services expect the company to clock 13% revenue CAGR for Cequa from USD70mn to USD100mn over FY23-26.

Winlevi – TRx volumes continue to witness sequential growth, post achieving targeted coverage of Dermatologists

Per latest monthly TRx data, Winlevi’s volumes for April-May 2023 were up 3.5% sequentially, while declining 5% YoY. Annualized run-rate for May 2023 of 423K is slightly higher than FY23 TRx volume for Winlevi, which is around 414K.

Absorica – Through brand, AG and LD version, Sun gained MS from Upsher-Smith/Mayne 

Sun’s MS in Absorica improved to 54.4% in May 2023 versus 42.8% in FY23. It gained MS from UpsherSmith/Mayne, as the latter’s MS dropped to ~39% in May 2023 versus ~52% in FY23. While Teva garnered 7% MS in May 2023 versus ~5% MS in FY23.

However, analysts at IIFL Capital Services expect Sun’s revenue from Absorica to decline from USD50mn in FY23 to USD25mn in FY26, owing to continued risk of further generic competition in the product.

Even after Mohali plant non-compliance action, Sun’s MS in Pentasa improves

Sun has continued to gain MS in gPentasa, given the absence of incremental generic competition from other players due to difficulties in assessing bioequivalence. This is even after USFDA escalated the non-compliance action on Sun’s Mohali plant where gPentasa is manufactured. The company has captured ~58% MS in gPentasa during April-May 2023 (up from ~55% in Q4FY23 and ~53% in Q3FY23).

Brovana MS ramp-up to ~17%

Sun’s MS in gBrovana further improved from ~9% in Q4FY23 to ~17% in April-May 2023, on gaining MS (~600bps) at the expense of other generic players and branded product. Similarly, Teva also improved MS by ~700bps in April-May 2023 and its MS stood at ~17%. MS loss by generic players were: Slate (~640bps), Cipla (~650bps) and Lupin (~150bps) in April-May 2023 and branded product also lost ~130bps MS. Per Symphony data, Mankind has 2% MS in April-May 2023 and Lupin’s combined MS in Brovana (incl. the acquired brand) decreased to ~26% in April-May 2023 versus ~29% in Q4FY23.

Sun regains MS in Ambisome

Sun’s gAmbisome volumes fell drastically in Q4FY23 to ~5% and 1.3% in March 2023 versus ~26% in Q3FY23 as Aurobindo entered and disrupted the market. However, Sun has regained some MS and captured 8.3% MS in May 2023, at the expense of Astellas (innovator) whose MS fell from ~90% in March 2023 to ~84% in May 2023. However, Aurobindo’s MS stood at 7.8% in May 2023. 

Trokendi XR – Zydus loses MS as competition enters

Within 3 months of launch, Zydus captured ~40% MS in March 2023 but it lost MS as competition – Endo and Teva launched their products. Per Symphony data, Zydus’ MS declined to ~26% in May 2023, while Endo/Teva has ~10/5% MS respectively in May 2023. There are ongoing pending generic litigations with other generic players such as Ajanta, Torrent, Lupin, Alkem and Dr. Reddy’s.

Chantix – Endo had 88-89% MS during CY22

Per Symphony IU volumes data, Endo launched gChantix in September 2021 and has cornered ~87% MS in April-May 2023. In CY22 it had ~89% MS and was as high as 98% in February 2023. However, over the last 2-3 months, Endo’s MS has declined to 84% in May 2023 and Apotex (only other generic player) has improved from 5.4% in March 2023 to ~16% in May 2023. On the other hand, Pfizer’s (innovator) MS is negligible. 

Endo recorded USD77/300mn of sales in Q1CY23/CY22. Given its MS of 87/89% respectively, analysts at IIFL Capital Services estimate Chantix’s market size to be around USD300-320mn. Zydus has recently got an approval from USFDA to launch gChantix and analysts at IIFL Capital Services believe Zydus can garner 12-15% MS with 40% price erosion.

Lupin and Teva launch gPrezista in June 2023

J&J (innovator) had the entire market of Prezista till May 2023 and its two strengths – 600mg and 800mg formed almost the entire market. Lupin has launched both 600mg and 800mg strength in June 2023, on which it has 180-day exclusivity. While Teva has also launched the 600mg strength on which it has 180 day shared exclusivity with Lupin.

 

Cipla further improves MS in Lanreotide

Cipla has been gaining MS QoQ in Lanreotide, since its launch in February 2022. The company has garnered ~16% MS during April-May 2023 versus ~15.5% in Q4FY23 and ~13.3% in Q3FY23. Analysts at IIFL Capital Services expect revenue from Lanreotide to augment from ~USD68mn in FY23 to ~USD105mn in FY26. With likely delays in approval for Abraxane and Advair due to plant issues, Cipla’s FY24 US growth (USD106mn incremental sales) will largely rely on Revlimid (USD73mn) and marginal scale-up in Lanreotide (USD33mn).

Albuterol – Cipla’s MS continues to decline, while Lupin’s remains stable

Cipla’s MS in Albuterol decreased to ~12% during April-May 2023 versus ~15% in Q4FY23, whereas Lupin’s MS in Albuterol remains stable at ~15% over the past 5-6 quarters. However, Lupin’s MS in Proair market fell marginally to ~33% during April-May 2023 versus ~34% in Q4FY23, as Teva continues to garner more MS. Hikma’s MS in Proventil further improves from ~25% in Q4FY23 to ~26% in April-May 2023, at the expense of MS loss for Cipla from ~63% in Q4FY23 to ~57% in April-May 2023.

Advair – Prasco and Hikma gains MS

GSK (innovator) marginally lost ~30bps MS in Advair during April-May 2023 versus Q4FY23, along with Mylan (~130bps) and Teva (~20bps). This was captured by Prasco (~160bps) and Hikma (~20bps). GSK still has ~53% MS in Advair, while Prasco/Mylan/Hikma/Teva have ~13.6%/16%/9%/8.6% MS respectively. Cipla was issued a ‘483 with 8 observations for its Indore facility and Advair is being site transferred to Cipla’s US facility. Advair launch will be delayed by 12 months as the facility requires USFDA inspection.

Perforomist – Teva continues to lose MS to Lupin & Alembic

Teva continued to lose MS in Perforomist and lost ~960bps MS in April-May 2023, after losing 530bps in Q4FY23 and 860bps in Q3FY23. This loss of MS by Teva has been captured by Lupin and Alembic. Per Symphony data, Lupin launched gPerforomist in Q3FY23 and has captured 20% MS in April-May 2023 versus 13.5% in Q4FY23 (650bps improvement). Alembic has captured 1500bps since Q3FY23 and 270bps in April-May 2023 versus Q4FY23. Mylan’s MS has been stable at 34.6% in April-May 2023.

Vasostrict – Aurobindo and Amphastar continue to gain MS while Amneal maintains MS

Aurobindo has sharply ramped up MS in Vasostrict over March-May 2023 and improved from 16-17% over November 2022-February 2023 to 24-34% over March-May 2023. Similarly, Amphastar has seen improvement from mid-to-high single digits during Q3-Q4FY23 to 11-12% during April-May 2023. Amneal has maintained 18-19% MS in April-May 2023. Par, Eagle and American Regent continue to lose MS inVasostrict during April-May 2023 and their MS stands at ~27/1/9% in April-May 2023 versus ~28/11/11% in Q4FY23. On the other hand, Dr. Reddy’s saw ~150bps improvement to 3.4% during April-May 2023.

Vascepa – Hikma loses 200bps MS and Dr. Reddy’s once again has the highest MS among generics During April-May 2023, Amarin (innovator) along with latest entrants Teva and McKesson, improved MS by 110/80/100bps over Q4FY23 while Hikma/Dr. Reddy’s/Apotex lost MS of 220/20/50bps respectively during the same period. However, Dr. Reddy’s once again has the highest MS among generic players as Hikma loses 200bps MS during April-May 2023 versus Q4FY23. Per Symphony data, MS of Dr. Reddy’s and Apotex have been steady at ~15-16% and ~8-9% over past 4-5 quarters.

Given that Amarin still has ~57% MS, there is further room for generics to garner additional MS from the innovator. Zydus has got FA from USFDA for Vascepa in April. Analysts at IIFL Capital Services believe it can gain MS of 12-13%. This can impact Dr. Reddy’s, as Vascepa is one of the top-5 products for the company and analysts at IIFL Capital Services estimate contribution of ~6-8% to Dr. Reddy’s ex-Revlimid US revenue.

Suboxone – Dr. Reddy’s improves MS at the expense of Reckitt Benckiser (innovator) and Alvogen

Per latest Symphony data, Dr. Reddy’s MS stood at ~24% during April-May 2023 — a 430bps gain over Q4FY23 as the innovator and Alvogen lost 60/390bps MS respectively during the same period. Apotex has not launched the product so far as TRx volumes are not yet reflecting in the latest Symphony data. Analysts at IIFL Capital Services believe generic players can potentially lose MS upon Apotex’s launch.

Aczone – Torrent/Mayne’s MS remains stable over the past 4 months

Torrent/Mayne’s MS in Aczone improved to 54% during April-May 2023 versus 52% in Q4FY23. This MS gain came at the expense of MS loss by innovator who lost ~200bps MS during the same period. Innovator’s MS stood at 21% in April-May 2023 versus 23% in Q4FY23 while Taro’s MS dropped slightly from 22% in Q4FY23 to 21% in April-May 2023.

Insulin Glargine – Biocon’s MS is stable while Lantus gains MS

In April-May 2023, Biocon’s MS in Insulin Glargine is stable at ~13.2% and Sanofi’s MS improved to ~65% from ~64% in Q4FY23. Eli Lilly’s MS in Insulin Glargine declines furthers to 22% in April-May 2023 versus 23% in Q4FY23. Biocon aims to further gain MS in Insulin Glargine.

Trastuzumab – Biocon ramps up MS in April-May 2023

In April-May 2023, Biocon improved MS in Trastuzumab to 10%, which had been stable at 8.3-8.6% over September 2022-March 2023. Teva/Pfizer has also gradually ramped up its MS from 1.5/18% in Q2FY23 to 2/21.6% respectively in April-May 2023. The innovator continues to cede MS to biosimilar players and its MS further declines from ~31% in Q4FY23 to ~29% in April-May 2023.

Pegfilgrastim – Biocon further gains MS in May 2023

In its Q4FY23 earnings call, Biocon’s management highlighted that they have around mid-teen MS in Pegfilgrastim, which they aim to expand further. Per Symphony data, Biocon’s MS further improves to ~16% in May 2023 from 14.4% in Q4FY23 versus ~11.7% in Q3FY23. MS of Coherus and Sandoz further declines from ~13%/15.6% during Q4FY23 to ~12.6%/14% during April-May 2023. Through the Onpro version, Amgen (innovator) continues to maintain MS of ~57-58% in the Trastuzumab market.