ATELVIA Drug Patent Profile

When do Atelvia patents expire, and when can generic versions of Atelvia launch?

Atelvia is a drug marketed by Apil and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-four patent family members in thirty-three countries.

The generic ingredient in ATELVIA is risedronate sodium. There are nineteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Atelvia

A generic version of ATELVIA was approved as risedronate sodium by TEVA PHARMS USA on October 5^th, 2007.

Summary for ATELVIA

International Patents:	84
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	2
Patent Applications:	3,969
Drug Prices:	Drug price information for ATELVIA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ATELVIA
What excipients (inactive ingredients) are in ATELVIA?	ATELVIA excipients list
DailyMed Link:	ATELVIA at DailyMed

See drug prices for ATELVIA

See drug sales revenues for ATELVIA

Recent Clinical Trials for ATELVIA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wake Forest University Health Sciences	Phase 3
National Cancer Institute (NCI)	Phase 2
Wake Forest University Health Sciences	Phase 2

See all ATELVIA clinical trials

Pharmacology for ATELVIA

Drug Class

Bisphosphonate

Paragraph IV (Patent) Challenges for ATELVIA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATELVIA	Delayed-release Tablets	risedronate sodium	35 mg	022560	1	2011-06-09

US Patents and Regulatory Information for ATELVIA

ATELVIA is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	AB	RX	Yes	Yes			Y
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	AB	RX	Yes	Yes			Y
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	AB	RX	Yes	Yes			Y

Expired US Patents for ATELVIA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010

International Patents for ATELVIA

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

Country	Patent Number	Title	Estimated Expiration
Morocco	28657
Spain	557322
South Korea	20080083068
Portugal	2269584

Supplementary Protection Certificates for ATELVIA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0186405	SPC/GB00/021	United Kingdom		PRODUCT NAME: (1-HYDROXY-2-(3-PYRIDINYL)ETHYLIDENE)BIS(PHOSPHONIC ACID) "RESIDRONATE" AND SALTS THEREOF, ESPECIALLY THE SODIUM SALT; REGISTERED: SE 15296 19991007; SE 15297 19991007; UK PL 00364/0070 20000316
0186405	2000C/028	Belgium		PRODUCT NAME: NATRIUMRISEDRONAAT; NAT. REGISTRATION NO/DATE: 354 IS 498 F3 20000508; FIRST REGISTRATION: SE 15290 19991007
0186405	C300031	Netherlands		PRODUCT NAME: RISEDRONINEZUUR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF FARMACEUTISCH AANVAARDBARE ESTER, IN HET BIJZONDER NATRIUMRISEDRONAAT; NAT REGISTRATION NO/DATE: RVG 24990 20000609; FIRST REGISTRATION: SE 15290 - 15297 19991007

ATELVIA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Atelvia

Introduction to Atelvia

Atelvia, a delayed-release formulation of risedronate sodium, was approved by the FDA on October 8, 2010, for the treatment and prevention of osteoporosis in postmenopausal women. It is manufactured by Warner Chilcott and is a variant of the existing drug Actonel, with the same active ingredient but a new delivery mechanism.

Market Context: Osteoporosis Treatment

The osteoporosis treatment market is highly competitive and has been impacted by the introduction of generic versions of key drugs. For instance, the generic version of Merck’s Fosamax (alendronate) became available in 2008, significantly affecting the sales of branded bisphosphonates like Actonel and Boniva[1].

Competitive Landscape

Atelvia entered a market dominated by other bisphosphonates such as Actonel (risedronate sodium), Boniva (ibandronate sodium), and Fosamax (alendronate). Actonel, in particular, faced declining sales due to patent expiration and generic competition. However, the introduction of Atelvia, with its delayed-release formulation, extended the patent life of risedronate sodium until 2026[2].

Marketing and Advertising Strategies

Warner Chilcott employed a strategic marketing approach to differentiate Atelvia from its predecessor, Actonel. The delayed-release coating eliminated the fasting requirements associated with traditional bisphosphonates, making it more convenient for patients. This marketing tactic was crucial in maintaining market share despite the presence of generics[2].

Financial Performance

In the year leading up to Atelvia's approval, the osteoporosis market saw a significant decline in sales. Total sales across the category dropped by nearly 14% to $2.26 billion from $2.62 billion in the previous year. Actonel, despite its declining sales, still generated nearly $600 million in the 12-month period ending in October 2010[1].

Direct-to-Consumer (DTC) Spending

Warner Chilcott reduced its offline DTC spending for Actonel by 63% in 2010, from $65 million to $24 million. However, the introduction of Atelvia allowed the company to maintain a presence in the market. While specific DTC spending figures for Atelvia are not available, the overall strategy involved leveraging the brand recognition of Actonel to promote Atelvia[1].

Patent Protection and Market Impact

The patent protection for Atelvia until 2026 was a critical factor in its financial trajectory. This extension allowed Warner Chilcott to continue generating revenue from the drug without immediate generic competition. The strategy of introducing a new formulation with patent protection is known as "product hopping," which can reduce the market share of generic entrants by up to 29% in the first year after generic entry[4].

Clinical and Safety Profile

Atelvia's clinical trials showed a safety and tolerability profile similar to its immediate-release counterpart. The drug reduced bone turnover markers significantly, with decreases in urinary collagen cross-linked N-telopeptide and serum bone-specific alkaline phosphatase observed within a year of treatment. However, adverse reactions such as gastrointestinal disorders, musculoskeletal pain, and infections were reported in clinical trials[5].

Patient Acceptance and Adverse Reactions

Patient acceptance of Atelvia has been mixed. While the delayed-release formulation was designed to be easier to tolerate, some patients have reported severe adverse reactions, including gastrointestinal issues, back pain, and joint soreness. These reactions highlight the need for careful patient selection and monitoring[2].

Impact of Generic Competition

The introduction of generics in the osteoporosis market has significantly impacted the sales of branded drugs. Generic versions typically lead to a decline in drug prices, with studies showing that prices can drop substantially after multiple generic entrants. However, Atelvia's patent protection has allowed it to maintain a market presence despite this competition[4].

Revenue Expectations and Market Size

The revenue expectations for Atelvia are influenced by its market size and the presence of other bisphosphonates. Given the decline in the overall osteoporosis market, Atelvia's sales have been crucial for Warner Chilcott. The drug's ability to maintain a significant market share is attributed to its unique formulation and extended patent life[1].

Regulatory Environment

The regulatory environment plays a critical role in the financial trajectory of pharmaceuticals. FDA approvals, patent extensions, and safety warnings all impact how a drug is perceived and prescribed. Atelvia's approval and subsequent patent protection have been key factors in its market success[3].

Future Outlook

The future outlook for Atelvia is tied to its ability to maintain market share against generic competition and other branded drugs. As the patent protection nears its end in 2026, Warner Chilcott will need to strategize to retain its position in the osteoporosis treatment market. This could involve further innovations, expanded indications, or strategic partnerships[2].

Key Takeaways

• Market Differentiation: Atelvia's delayed-release formulation differentiates it from other bisphosphonates, making it more convenient for patients.
• Patent Protection: The extended patent life until 2026 has been crucial for maintaining revenue.
• Competitive Landscape: Atelvia competes in a market dominated by generics and other branded bisphosphonates.
• Financial Performance: Despite market declines, Atelvia has contributed significantly to Warner Chilcott's revenue.
• Clinical and Safety Profile: Atelvia has a similar safety profile to its immediate-release counterpart but with some reported adverse reactions.
• Regulatory Environment: FDA approvals and patent extensions have been key to Atelvia's market success.

FAQs

What is Atelvia, and how does it differ from Actonel?

Atelvia is a delayed-release formulation of risedronate sodium, similar to Actonel but with a new delivery mechanism that eliminates fasting requirements.

What is the impact of Atelvia's patent protection on its market performance?

Atelvia's patent protection until 2026 has allowed it to maintain market share and revenue despite the presence of generic competition.

How does Atelvia compare to other bisphosphonates in terms of safety and efficacy?

Atelvia has a similar safety and efficacy profile to its immediate-release counterpart, with significant reductions in bone turnover markers, but it also reports some adverse reactions.

What are the common adverse reactions associated with Atelvia?

Common adverse reactions include gastrointestinal disorders, musculoskeletal pain, and infections.

How does the regulatory environment influence Atelvia's financial trajectory?

FDA approvals, patent extensions, and safety warnings all play a critical role in Atelvia's market success and financial performance.

Sources

1. Roche maintained DTC spending on Boniva, while competitors cut back. MMM-Online.
2. Atelvia: My Review. Save Our Bones.
3. In Brief: Delayed-Release Risedronate (Atelvia). The Medical Letter.
4. COST OF GENERIC DRUG DEVELOPMENT AND APPROVAL FINAL. ASPE.
5. ATELVIA- risedronate sodium tablet, delayed release. DailyMed.