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Last Updated: December 22, 2024

ADDERALL XR 30 Drug Patent Profile


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When do Adderall Xr 30 patents expire, and what generic alternatives are available?

Adderall Xr 30 is a drug marketed by Takeda Pharms Usa and is included in one NDA.

The generic ingredient in ADDERALL XR 30 is amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. There are fifty-five drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate profile page.

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Drug patent expirations by year for ADDERALL XR 30
Recent Clinical Trials for ADDERALL XR 30

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

SponsorPhase
Boston Children's HospitalPhase 1
Eva SzigethyPhase 4
The Beckwith InstitutePhase 4

See all ADDERALL XR 30 clinical trials

Pharmacology for ADDERALL XR 30

US Patents and Regulatory Information for ADDERALL XR 30

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa ADDERALL XR 30 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-003 Oct 11, 2001 AB1 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ADDERALL XR 30

International Patents for ADDERALL XR 30

See the table below for patents covering ADDERALL XR 30 around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 0023055 ⤷  Subscribe
Germany 69940673 ⤷  Subscribe
Austria 427101 ⤷  Subscribe
European Patent Office 1977736 ⤷  Subscribe
Japan 2008303223 ORAL PULSED DOSE DRUG DELIVERY SYSTEM ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

ADDERALL XR 30 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Adderall XR 30mg

Introduction to Adderall XR

Adderall XR, an extended-release formulation of a mixed salt of a single entity amphetamine, is a central nervous system (CNS) stimulant used primarily for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. The drug, originally developed by Shire Plc, has been a significant player in the ADHD medication market.

Market Value and Revenue

Adderall XR and its generic versions have a substantial market presence. As of 2020, the estimated IQVIA market value for Adderall XR and its generic versions was approximately $1.3 billion for the 12 months ending January 2020[5].

Historically, Adderall XR has been one of Shire's biggest earners, with revenues of $532 million in 2011 alone[2].

Generic Competition and Market Impact

The introduction of generic versions of Adderall XR has significantly impacted the market dynamics. Lannett Company, Inc., for example, began marketing a generic version of Adderall XR in March 2020, offering capsules in strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg[5].

The entry of generic competitors has led to a decline in Shire's sales. For instance, after the FDA approved a generic version from Watson subsidiary Actavis in June 2012, Shire's sales of Adderall XR dropped by 32% in the third quarter of that year[2].

Pricing and Cost Dynamics

The pricing of Adderall XR and its generics has been volatile, particularly in recent years. The cost of ADHD medications, including Adderall XR, has increased significantly. For example, the price of a 30-day supply of Adderall XR 10mg can fluctuate dramatically, from $10 to $158 within a few months, due to supply and demand issues[4].

Without insurance, a supply of 100 capsules of 10mg Adderall XR can cost around $759.54, highlighting the financial burden on patients[4].

Supply Chain and Shortages

The ADHD medication market, including Adderall XR, has faced significant supply chain disruptions. A shortage of Adderall reported by the FDA in October 2022 has continued to affect patients, with no clear end in sight. This shortage has exacerbated the pricing issues, further increasing the financial strain on patients and families[4].

Legal and Contractual Disputes

The history of Adderall XR is also marked by legal disputes and contractual agreements. Shire agreed to pay Impax $48 million to settle claims related to the supply of an authorized generic version of Adderall XR. This settlement resolved a court battle that began in November 2010 and included updates to their license and distribution agreement[2].

Additionally, Shire entered into pay-to-delay deals, such as the one with Barr Laboratories, where Shire agreed to pay significant amounts to delay the entry of generic competitors into the market[3].

Consumer Impact and Alternatives

The financial and supply challenges associated with Adderall XR have forced patients and caregivers to seek alternative treatments. Some patients have found relief through other medications like Cotempla XR-ODT, although these alternatives often come with their own set of challenges, including high costs and insurance coverage issues[4].

Industry Expert Insights

Industry experts highlight the complexities of the ADHD medication market. Dr. Ann Childress, during a presentation at the 2024 APSARD conference, noted that insurance coverage is a critical factor for many patients when choosing an ADHD medication, underscoring the financial considerations that patients face[4].

Financial Performance of Key Players

Lannett Company, Inc., one of the key players in the generic Adderall XR market, has seen significant activity in launching new products. In addition to generic Adderall XR, Lannett has launched several other products, contributing to its financial performance. However, the company's forward-looking statements are subject to various market and regulatory risks[5].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Adderall XR. FDA approvals and settlements between companies can significantly impact the availability and pricing of the drug. For instance, the FDA's approval of generic versions has led to increased competition, affecting the market share of the original brand[2][5].

Key Takeaways

  • Market Value: Adderall XR and its generics have a substantial market value, estimated at $1.3 billion as of 2020.
  • Generic Competition: The entry of generic competitors has reduced Shire's sales and changed market dynamics.
  • Pricing Volatility: The cost of Adderall XR has seen significant fluctuations, particularly due to supply chain issues.
  • Supply Chain Disruptions: The ongoing shortage of Adderall has exacerbated pricing and availability issues.
  • Legal and Contractual Disputes: Shire has been involved in several legal disputes and pay-to-delay deals to manage generic competition.
  • Consumer Impact: Patients face financial and supply challenges, leading to the exploration of alternative treatments.

FAQs

Q: What is the current market value of Adderall XR and its generic versions? A: The estimated IQVIA market value for Adderall XR and its generic versions was approximately $1.3 billion for the 12 months ending January 2020[5].

Q: How has the introduction of generic versions affected Shire's sales of Adderall XR? A: The introduction of generic versions led to a decline in Shire's sales, with a 32% drop in the third quarter of 2012 following FDA approval of a generic version from Watson subsidiary Actavis[2].

Q: What are the current pricing challenges for Adderall XR? A: The cost of Adderall XR has increased significantly due to supply and demand issues, with prices fluctuating dramatically over short periods[4].

Q: Is there an ongoing shortage of Adderall XR? A: Yes, a shortage reported by the FDA in October 2022 continues to affect patients, with no clear end in sight[4].

Q: How have legal disputes impacted the market for Adderall XR? A: Legal disputes, including pay-to-delay deals and contractual agreements, have influenced the timing and nature of generic competition in the market[2][3].

Sources

  1. Lannett To Commence Marketing Generic Adderall® XR - BioSpace
  2. Shire pays $48m to settle generic Adderall XR claims with Impax - PMLive
  3. What is the price of pay-to-delay deals? - Farasat Bokhari
  4. ADHD Medication Costs Soar: Price Report - ADDitude
  5. Lannett Begins Marketing Generic Adderall® XR - PR Newswire

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