TARPEYO Drug Patent Profile

Which patents cover Tarpeyo, and what generic alternatives are available?

Tarpeyo is a drug marketed by Calliditas and is included in one NDA. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-two patent family members in fourteen countries.

The generic ingredient in TARPEYO is budesonide. There are twenty-two drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the budesonide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Tarpeyo

A generic version of TARPEYO was approved as budesonide by TEVA PHARMS on November 18^th, 2008.

Summary for TARPEYO

International Patents:	22
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Drug Prices:	Drug price information for TARPEYO
What excipients (inactive ingredients) are in TARPEYO?	TARPEYO excipients list
DailyMed Link:	TARPEYO at DailyMed

See drug prices for TARPEYO

Pharmacology for TARPEYO

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for TARPEYO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TARPEYO	Delayed-release Capsules	budesonide	4 mg	215935	1	2024-12-26

US Patents and Regulatory Information for TARPEYO

TARPEYO is protected by six US patents and two FDA Regulatory Exclusivities.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes	11,896,719
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes	8,491,932		Y
Calliditas	TARPEYO	budesonide	CAPSULE, DELAYED RELEASE;ORAL	215935-001	Dec 15, 2021		RX	Yes	Yes

EU/EMA Drug Approvals for TARPEYO

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Dr. Falk Pharma GmbH	Jorveza	budesonide	EMEA/H/C/004655 Jorveza is indicated for the treatment of eosinophilic esophagitis (EoE) in adults (older than 18 years of age).	Authorised	no	no	yes	2018-01-08
Stada Arzneimittel AG	Kinpeygo	budesonide	EMEA/H/C/005653 Kinpeygo is indicated for the treatment of primary immunoglobulin A (IgA) nephropathy (IgAN) in adults at risk of rapid disease progression with a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/gram.	Authorised	no	no	yes	2022-07-15

International Patents for TARPEYO

See the table below for patents covering TARPEYO around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2023210461
Hong Kong	1158510	COMPOSITIONS FOR THE ORAL DELIVERY OF CORTICOSTEROIDS
United Kingdom	202210430
United Kingdom	0808537

Supplementary Protection Certificates for TARPEYO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	132021000000095	Italy		PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
2435024	2021C/518	Belgium		PRODUCT NAME: UNE COMBINAISON DE FORMOTEROL (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), GLYCOPYRROLATE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET BUDESONIDE (Y COMPRIS TOUS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1498 20201210
2435024	2190014-7	Sweden		PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210
0613371	SPC/GB02/033	United Kingdom		PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515

Market Dynamics and Financial Trajectory for TARPEYO

Introduction to TARPEYO

TARPEYO, developed by Calliditas Therapeutics, is a groundbreaking drug approved by the FDA for reducing kidney loss in adult patients with IgA nephropathy (IgAN), a rare and debilitating disease. Here, we delve into the market dynamics and financial trajectory of TARPEYO, highlighting its successes, challenges, and future prospects.

Orphan Drug Designation and Market Access

TARPEYO exemplifies the benefits of the Orphan Drug Designation (ODD) pathway. This designation streamlined the approval process, reduced competition, and supported a higher list price due to the high unmet need in a specific patient population. The drug initially received Accelerated Approval and ODD, which was later expanded to include a broader patient population, extending exclusivity until 2030[1].

Regulatory Milestones

A significant milestone for TARPEYO was the full FDA approval in 2023, marking a pivotal moment in Calliditas Therapeutics' development. This approval solidified the drug's position as the first approved treatment for IgAN, a disease with limited treatment options[2].

Market Performance and Revenue Growth

TARPEYO has demonstrated robust market acceptance and significant revenue growth. In Q4 2023, net sales jumped from SEK 167.3 million in 2022 to SEK 347.3 million, reflecting a substantial increase. For the full year 2023, net sales rose from SEK 802.9 million in 2022 to SEK 1,206.9 million, indicating a strong revenue trajectory[2].

Quarterly and Annual Sales

• Q4 2022: Net sales of TARPEYO amounted to SEK 167.3 million.
• Q4 2023: Net sales increased to SEK 347.3 million.
• 2022: Total net sales were SEK 802.9 million.
• 2023: Total net sales were SEK 1,206.9 million[2][3].

Financial Outlook

Calliditas Therapeutics projects continued revenue growth for 2024, with estimated total net sales ranging between USD 150-180 million. This optimistic outlook is supported by the drug's commercial success and the company's strategic partnerships, such as with Everest Medicines for the commercialization of Nefecon in China and STADA for Kinpeygo in Europe[2].

Competitive Landscape

The market for IgAN treatments is evolving, with TARPEYO and FILSPARI (developed by Travere) gaining traction. However, the high price of TARPEYO/Kinpeygo could constrain its use, as nephrologists are cautious about prescribing expensive therapies unless they demonstrate significant efficacy. The market is also expected to become more crowded with other potential competitors in late-stage development[4][5].

Pricing and Market Acceptance

Despite its high price, TARPEYO has seen strong market acceptance, partly due to its disease-modifying potential and the lack of alternative treatments for IgAN. However, the pricing remains a hurdle, and the drug's success will depend on its ability to demonstrate long-term efficacy and safety, as well as its positioning in the treatment algorithm as a third- or fourth-line therapy[4][5].

Patient and Physician Perceptions

The early stabilization of eGFR in patients at risk of rapid disease progression has been a key factor in TARPEYO's acceptance. Nephrologists continue to grow in number, with 642 unique prescribers in 2022, indicating increasing confidence in the drug. Patient assistance programs and peer-to-peer recommendations based on early patient successes have also contributed to its market penetration[2][3].

Global Expansion

Calliditas Therapeutics is expanding its global footprint through strategic partnerships. The transfer of the Marketing Authorization Holder (MAH) approval to Everest Medicines and the commercial launch of Nefecon in China are significant steps. Additionally, the company has partnered with Viatris Pharmaceuticals Japan to develop Nefecon for the Japanese market, and STADA for Kinpeygo in the European Economic Area (EEA), Switzerland, and the UK[2][3].

Intellectual Property and Regulatory Barriers

The Notice of Allowance for a US patent extending through 2043 strengthens Calliditas Therapeutics' intellectual property position, creating a substantial barrier to entry for competitors. This patent protection, combined with the drug's exclusive approval status, positions TARPEYO for long-term market dominance[2].

Future Prospects and Key Events

• Upcoming Clinical Trials: The readout of the Nefecon Open-label Phase 3 extension trial will be crucial for understanding the long-term efficacy and safety of TARPEYO.
• New Indications: The initiation of a Phase 2 clinical study for setanaxib in Alport syndrome and head and neck cancer could diversify the company's portfolio and open new revenue streams.
• European Approval: The European Commission's decision on Kinpeygo's full approval will be a key event to watch, as it could significantly impact the company's market presence in Europe[2].

Challenges and Risks

Despite the successes, Calliditas Therapeutics faces several challenges, including managing expenses to achieve profitability, navigating regulatory hurdles, and competing in a potentially crowded market. The company's operating loss, although reduced, and the significant cash burn are areas of concern for investors[2].

Key Takeaways

• Regulatory Success: Full FDA approval and Orphan Drug Designation have been pivotal for TARPEYO's market access.
• Revenue Growth: Significant increases in net sales reflect strong market acceptance.
• Global Expansion: Strategic partnerships are key to expanding the drug's global footprint.
• Pricing Hurdles: The high price of TARPEYO could constrain its use unless it demonstrates significant efficacy.
• Future Prospects: Upcoming clinical trials and potential new indications could further solidify the drug's market position.

FAQs

What was the net sales for TARPEYO in Q4 2023 compared to Q4 2022?

The net sales for TARPEYO in Q4 2023 were SEK 347.3 million, compared to SEK 167.3 million in Q4 2022[2].

What was the operating income for Q4 2023 and Q4 2022?

In Q4 2023, Calliditas Therapeutics reported an operating income, although the exact figure is not specified. In Q4 2022, the operating profit was SEK 32.5 million[2][3].

What was the cash amount as of December 31, 2023, compared to December 31, 2022?

The cash position decreased significantly, reflecting substantial cash burn, but the exact figures are not provided in the latest reports[2].

What was the net sales for TARPEYO in 2023 compared to 2022?

The net sales for TARPEYO in 2023 were SEK 1,206.9 million, compared to SEK 802.9 million in 2022[2].

How does the high price of TARPEYO impact its market acceptance?

The high price of TARPEYO could constrain its use, as nephrologists are reluctant to prescribe expensive therapies unless they demonstrate significant efficacy. However, early patient successes and disease-modifying potential have helped in its market penetration[5].

What are the key upcoming events that could impact TARPEYO's market position?

The readout of the Nefecon Open-label Phase 3 extension trial, the initiation of new clinical studies, and the European Commission's decision on Kinpeygo's full approval are key events to watch[2].