NATPARA Drug Profile

Summary for Tradename: NATPARA

High Confidence Patents:	1
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for NATPARA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NATPARA

Recent Clinical Trials for NATPARA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Entera Bio Ltd.	Phase 2
Shire	Phase 1
Haukeland University Hospital	Early Phase 1

See all NATPARA clinical trials

Recent Litigation for NATPARA

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Pandora Marketing LLC	2024-01-31
GENENTECH, INC. v. DR. REDDYS LABORATORIES, INC.	2023-11-17
Genentech, Inc. v. Biogen MA Inc.	2023-07-13

See all NATPARA litigation

PTAB Litigation

Petitioner	Date
	2018-07-13
	2017-07-28
Pfizer, Inc.	2017-05-19

See all NATPARA litigation

Pharmacology for NATPARA

Established Pharmacologic Class	Parathyroid Hormone
Chemical Structure	Parathyroid Hormone

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for NATPARA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NATPARA Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511	5,496,801	2039-03-29	Company disclosures

3) Low Certainty: US Patents for NATPARA Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511	10,011,643	2031-06-07	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511	10,016,338	2033-03-11	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511	10,028,955	2032-03-30	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511	10,029,015	2024-07-05	Patent claims search
Takeda Pharmaceuticals U.s.a., Inc.	NATPARA	parathyroid hormone	For Injection	125511	10,040,848	2033-02-15	Patent claims search

International Patents for NATPARA

Country	Patent Number	Estimated Expiration
China	1116897
European Patent Office	1880732
Finland	962593
Hong Kong	1010336
Portugal	735896

Market Dynamics and Financial Trajectory for the Biologic Drug: NATPARA

Introduction

NATPARA, a biologic drug used to treat hypoparathyroidism, has been a significant player in the rare disease market, but its journey has been marked by several challenges. This article delves into the market dynamics and financial trajectory of NATPARA, highlighting its impact, challenges, and the eventual decision to cease its production.

Market Size and Growth Prospects

The hypoparathyroidism treatment market, within which NATPARA operates, is projected to grow significantly. As of 2023, the market size was valued at USD 1.25 billion and is expected to reach USD 2.25 billion by 2032, growing at a CAGR of 6.8% from 2024 to 2032[1].

Product Type and Route of Administration

NATPARA falls under the category of parathyroid hormone (PTH) treatments. The oral sector, while dominant in the market, is not relevant to NATPARA as it is administered parenterally. The parenteral route, although less common, is crucial for drugs like NATPARA that require precise dosing and rapid action[1].

Distribution Channels

The distribution of NATPARA primarily occurs through hospital and retail pharmacies, which are expected to maintain the largest market share among all distribution channels. However, the supply chain disruptions faced by NATPARA have impacted its availability across these channels[1].

Historical Performance and Revenue

In its last full year of reported U.S. sales in 2018, NATPARA earned $230 million. This revenue was significant for Takeda's rare disease franchise, but subsequent manufacturing issues and recalls severely impacted its sales and market presence[4].

Manufacturing Issues and Recalls

The manufacturing saga of NATPARA began with a recall in 2019 due to concerns over rubber particulate contamination. Despite efforts to resolve these issues, Takeda faced continuous delays and setbacks, including a Complete Response Letter from the FDA in 2022, which further delayed its commercial return[4].

Impact of Supply Interruptions

The supply interruptions had a profound impact on patients and Takeda's financials. By March 2021, only about 400 patients were still receiving NATPARA under a special use program, down from approximately 2,800 before the recall. This reduction in patient numbers significantly affected revenue and market share[4].

Financial Implications for Takeda

Takeda's acquisition of Shire, which included NATPARA, was part of a $62 billion deal. While the integration of Shire initially boosted Takeda's financial outlook, the ongoing issues with NATPARA contributed to a decline in the rare disease franchise's revenues. For instance, in 2020, Takeda's rare disease franchise saw underlying revenues drop by 11% year-over-year, partly due to the absence of NATPARA sales[2].

Decision to Cease Production

After years of struggling with manufacturing issues, Takeda announced in October 2022 that it would cease all manufacturing of NATPARA by the end of 2024. This decision was made due to unresolved supply issues specific to the product, which Takeda could not resolve despite extensive efforts[4].

Patient Impact and Future Treatment Plans

The cessation of NATPARA production has significant implications for patients with hypoparathyroidism. Takeda has committed to maintaining treatment continuity for patients currently on NATPARA until the end of 2024, subject to available supply. Patients and healthcare providers are being advised to develop longer-term treatment plans, which may involve alternative therapies such as vitamin D analogues and calcium supplements[4].

Regulatory Oversight and Communication

Takeda has been working closely with regulatory authorities to address the manufacturing issues and ensure a smooth transition for patients. The company has communicated its plans and timelines to patients, healthcare providers, and regulatory bodies to minimize disruptions and ensure continuity of care[3][4].

Key Takeaways

• Market Growth: The hypoparathyroidism treatment market is expected to grow significantly, but NATPARA's production cessation will impact this growth.
• Manufacturing Issues: Continuous manufacturing problems led to the eventual decision to cease NATPARA production.
• Financial Impact: The absence of NATPARA sales has negatively affected Takeda's rare disease franchise revenues.
• Patient Impact: Patients will need to transition to alternative treatments, which could include vitamin D analogues and calcium supplements.
• Regulatory Oversight: Takeda has worked closely with regulatory bodies to manage the transition and ensure patient care.

FAQs

What is NATPARA used for?

NATPARA is a prescription parathyroid hormone used to control low blood calcium (hypocalcemia) in adults with hypoparathyroidism, often in conjunction with calcium and vitamin D[5].

Why was NATPARA recalled?

NATPARA was recalled in 2019 due to concerns over rubber particulate contamination in the product, leading to ongoing manufacturing issues and supply interruptions[4].

How has the recall affected patients?

The recall and subsequent supply interruptions have significantly reduced the number of patients receiving NATPARA, forcing them to seek alternative treatments and develop new treatment plans[4].

What is Takeda's plan for patients currently on NATPARA?

Takeda plans to maintain treatment continuity for patients currently on NATPARA until the end of 2024, subject to available supply, and is advising patients and healthcare providers to develop longer-term treatment plans[4].

What are the alternative treatments for hypoparathyroidism?

Alternative treatments include vitamin D analogues (such as Vitamin D2 and Vitamin D3) and calcium supplements, which are commonly used to manage hypocalcemia in patients with hypoparathyroidism[1].

Sources

1. Hypoparathyroidism Treatment Market Size, & Global Outlook - SNS Insider
2. Takeda unveils profit surprise on Shire integration—and no U.S. Natpara supply - FiercePharma
3. Information about NATPARA recall and supply update for patients - Natpara.com
4. Takeda is calling it quits on Natpara's US commercial return - FiercePharma
5. Drug Trials Snapshot: NATPARA (parathyroid hormone) - FDA.gov