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Last Updated: December 22, 2024

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE - Generic Drug Details


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What are the generic drug sources for amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate and what is the scope of freedom to operate?

Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate is the generic ingredient in sixteen branded drugs marketed by Takeda Pharms Usa, Actavis Elizabeth, Ani Pharms, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Endo Operations, Granules, Impax Labs, Lannett Co Inc, Nesher Pharms, Rhodes Pharms, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms Usa, Barr Labs Inc, Teva Womens, Accord Hlthcare, Alkem Labs Ltd, Alvogen, Barr, Cediprof Inc, Epic Pharma Llc, Norvium Bioscience, Nuvo Pharm, Oryza, Sandoz, Teva Pharms, and Zydus Pharms, and is included in forty-three NDAs. There are two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Twenty-eight suppliers are listed for this compound.

Pharmacology for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Paragraph IV (Patent) Challenges for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MYDAYIS Extended-release Capsules amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 12.5 mg and 25 mg 022063 1 2017-08-07
MYDAYIS Extended-release Capsules amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 37.5 mg and 50 mg 022063 1 2017-08-03
ADDERALL 7.5 Tablets amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 5 mg, 10 mg, 20 mg, 30 mg 011522 1 2009-11-18

US Patents and Regulatory Information for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Norvium Bioscience DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 206721-003 Nov 10, 2015 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Accord Hlthcare DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 214347-002 Nov 22, 2021 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Barr DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040422-002 Feb 11, 2002 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 205401-003 Jan 22, 2019 AB1 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Actavis Elizabeth DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 206340-006 Feb 5, 2016 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Specgx Llc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040440-007 Oct 7, 2003 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Teva Pharms Usa DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 210876-004 Jan 31, 2022 AB2 RX No No ⤷  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 AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-004 Jun 20, 2017 ⤷  Subscribe ⤷  Subscribe
Takeda Pharms Usa ADDERALL XR 5 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-005 May 22, 2002 ⤷  Subscribe ⤷  Subscribe
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-004 Jun 20, 2017 ⤷  Subscribe ⤷  Subscribe
Teva Womens ADDERALL 12.5 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 011522-012 Aug 31, 2000 ⤷  Subscribe ⤷  Subscribe
Takeda Pharms Usa ADDERALL XR 20 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-002 Oct 11, 2001 ⤷  Subscribe ⤷  Subscribe
Takeda Pharms Usa ADDERALL XR 30 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-003 Oct 11, 2001 ⤷  Subscribe ⤷  Subscribe
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-002 Jun 20, 2017 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Amphetamine-Based Medications: A Comprehensive Analysis

Introduction

Amphetamine-based medications, particularly those combining dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate, are widely used for treating Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy. This article delves into the market dynamics and financial trajectory of these medications, highlighting key aspects such as market value, competition, and distribution agreements.

Market Value and Revenue

The market for amphetamine-based medications, notably Adderall and its generic versions, is substantial. As of 2019, the estimated IQVIA market value for Adderall XR and its generic versions was approximately $1.3 billion for the 12 months ending October 2019[2].

Generic Competition and Market Impact

The introduction of generic versions of Adderall XR has significantly impacted the market. Companies like Lannett and Glenmark have entered into agreements to distribute generic versions of these medications. For instance, Lannett announced its plan to market a generic version of Adderall XR in late 2019, which includes strengths of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg tablets[2].

Glenmark Pharmaceuticals, in collaboration with Cediprof, has also secured an exclusive distribution agreement for the generic version of Adderall, which includes tablets of 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg. This move is expected to alleviate the shortage of these medications in the U.S. market[4].

Distribution Agreements and Partnerships

Distribution agreements play a crucial role in the market dynamics of these medications. Glenmark's partnership with Cediprof is a prime example, where Glenmark will distribute Cediprof's FDA-approved generic Adderall tablets. This agreement highlights the strategic alliances necessary to ensure a steady supply of these medications to the market[4].

Prescription Trends and Usage

Stimulant medications, including those containing amphetamine, dominate the ADHD treatment landscape. According to the IQVIA report on stimulant trends from 2012 to 2022, 90% of all ADHD treatment molecules dispensed were for stimulants, with the remaining 10% being non-stimulant medications. This trend indicates a strong and consistent demand for amphetamine-based treatments[5].

Financial Trajectory

The financial trajectory of these medications is influenced by several factors, including prescription rates, competition from generics, and distribution agreements. The market value of Adderall and its generics has remained robust, with the IQVIA data indicating a significant market presence.

As of January 2023, the market for Adderall tablets, including generic versions, continued to be highly valued, reflecting the ongoing demand for these medications. The financial performance of companies involved in the distribution and manufacturing of these generics, such as Lannett and Glenmark, is closely tied to their ability to meet this demand and navigate the competitive landscape[4].

Regulatory Environment

The regulatory environment is a critical factor in the market dynamics of amphetamine-based medications. These medications are classified as controlled substances due to their high potential for abuse and misuse. Regulatory bodies, such as the FDA, closely monitor their distribution and use to prevent diversion into illicit channels[1].

Risks and Side Effects

The financial trajectory of these medications can also be affected by their safety profile. Risks such as sudden death in patients with structural cardiac abnormalities, increased blood pressure and heart rate, and the potential for serotonin syndrome must be carefully managed. These risks necessitate frequent monitoring and reassessment of patients, which can impact prescribing patterns and, consequently, market dynamics[1].

Competitive Landscape

The competitive landscape for amphetamine-based medications is characterized by the presence of both branded and generic products. The entry of generic versions has increased competition, leading to potential price reductions and changes in market share. Companies like Teva, Lannett, and Glenmark are key players in this market, each vying for a significant share of the prescription volume[2][4].

Consumer Impact

For consumers, the availability of generic versions of Adderall and similar medications can be beneficial in terms of cost. Generic medications are often more affordable than their branded counterparts, making treatment more accessible to a wider population. However, the quality and efficacy of these generics must be ensured to maintain consumer trust and satisfaction[2][4].

Future Outlook

The future outlook for amphetamine-based medications remains positive, driven by the ongoing demand for effective ADHD and narcolepsy treatments. As more generic versions enter the market, competition is likely to increase, which could lead to further price reductions and improved accessibility.

Key Takeaways

  • Market Value: The market for amphetamine-based medications, such as Adderall and its generics, is valued at over $1 billion annually.
  • Generic Competition: The introduction of generic versions has significantly impacted the market, increasing competition and potentially reducing prices.
  • Distribution Agreements: Strategic partnerships between pharmaceutical companies are crucial for ensuring a steady supply of these medications.
  • Prescription Trends: Stimulant medications, including those containing amphetamine, dominate ADHD treatment.
  • Regulatory Environment: These medications are closely monitored due to their high potential for abuse and misuse.
  • Risks and Side Effects: Managing risks such as cardiac issues and serotonin syndrome is essential for patient safety and market stability.

FAQs

Q: What are the primary uses of amphetamine-based medications like Adderall? A: These medications are primarily used to treat Attention Deficit Hyperactivity Disorder (ADHD) and narcolepsy.

Q: What is the market value of Adderall and its generic versions? A: The estimated market value for Adderall XR and its generic versions was approximately $1.3 billion for the 12 months ending October 2019.

Q: Which companies are involved in the distribution of generic Adderall? A: Companies such as Lannett and Glenmark, in partnership with Cediprof, are involved in the distribution of generic Adderall.

Q: What are the potential risks associated with amphetamine-based medications? A: These medications carry risks such as sudden death in patients with structural cardiac abnormalities, increased blood pressure and heart rate, and the potential for serotonin syndrome.

Q: How do generic versions impact the market for amphetamine-based medications? A: Generic versions increase competition, potentially reducing prices and making treatment more accessible to a wider population.

Sources

  1. Drugs.com: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Tablets.
  2. BioSpace: Lannett To Commence Marketing Generic Adderall XR.
  3. California Prime Recovery: Amphetamine vs. Dextroamphetamine: Uses, Differences, Side Effects.
  4. PR Newswire: Glenmark and Cediprof Announce Exclusive Distribution Agreement.
  5. DEA Diversion Control Division: IQVIA Report on Stimulant Trends from 2012 - 2022.

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