Suppliers and packagers for TUXARIN ER

TUXARIN ER

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323	NDA	Mainpointe Pharmaceuticals	71269-040-10	100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-10)	2018-10-15
Mainpointe	TUXARIN ER	chlorpheniramine maleate; codeine phosphate	TABLET, EXTENDED RELEASE;ORAL	206323	NDA	Mainpointe Pharmaceuticals	71269-040-30	30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (71269-040-30)	2018-10-15

Suppliers for the Pharmaceutical Drug Tuxarin ER

Tuxarin ER, a combination of codeine phosphate and chlorpheniramine maleate, is an extended-release tablet approved for managing cough and upper respiratory symptoms in adults. As a Schedule III controlled substance, its production and distribution are tightly regulated. This report examines the key suppliers, manufacturers, and collaborators involved in bringing Tuxarin ER to market, drawing on regulatory filings, corporate announcements, and pharmaceutical databases.

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Manufacturer Overview: MainPointe Pharmaceuticals

Role as Primary Manufacturer

MainPointe Pharmaceuticals, LLC, headquartered in Louisville, Kentucky, holds the New Drug Application (NDA) for Tuxarin ER and serves as its sole manufacturer[2][8]. The company produces the drug in extended-release tablet form, with each dose containing 54.3 mg of codeine phosphate (equivalent to 40 mg of codeine) and 8 mg of chlorpheniramine maleate[6][7]. MainPointe’s facilities adhere to FDA Good Manufacturing Practices (GMP), ensuring consistency in the tablet’s inactive ingredients, which include hypromellose, lactose monohydrate, and magnesium stearate[3][4].

Regulatory Compliance and Distribution

As the NDA holder, MainPointe oversees regulatory compliance, including risk evaluation and mitigation strategies (REMS) for opioid-containing products. The drug’s label emphasizes warnings against use in pediatric populations and patients with respiratory conditions, reflecting MainPointe’s adherence to post-marketing requirements[6][8]. The company distributes Tuxarin ER directly to pharmacies and healthcare providers, with no authorized generic versions available as of March 2025[2].

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Development Partners and Collaborators

Nexgen Pharma’s Formulation Expertise

Nexgen Pharma, a specialty pharmaceutical company based in California, co-developed Tuxarin ER’s extended-release formulation. Their contribution included optimizing the matrix tablet technology to enable 12-hour dosing, which reduces the risk of dosing errors associated with liquid cough syrups[5][9]. Nexgen’s expertise in sustained-release systems allowed MainPointe to differentiate Tuxarin ER from immediate-release competitors.

Spriaso LLC’s Strategic Leadership

Spriaso LLC, a Utah-based firm, spearheaded the NDA submission and approval process. In 2015, Spriaso announced the FDA’s approval of Tuxarin ER, highlighting its status as the first long-acting codeine-chlorpheniramine combination not classified as a Schedule II controlled substance[5][9]. This strategic positioning aimed to improve patient access by easing pharmacy dispensing restrictions.

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Regulatory History and Market Exclusivity

FDA Approval and Labeling

The FDA approved Tuxarin ER on June 22, 2015, for adults aged 18 and older[6][8]. Key labeling provisions include:

• Contraindications for postoperative pain in pediatric tonsillectomy patients[6].
• Warnings about respiratory depression, addiction potential, and interactions with CNS depressants[1][4].
  MainPointe maintains exclusivity through patent protections and regulatory data exclusivity, which together block generic entry until at least 2030[2][9].

DEA Scheduling and Control

Tuxarin ER’s classification as a Schedule III drug under the Controlled Substances Act reflects its lower abuse potential compared to Schedule II opioids like hydrocodone[8]. This scheduling allows refills with a prescription but mandates stringent record-keeping by pharmacies.

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Supply Chain and Raw Material Sourcing

Active Pharmaceutical Ingredients (APIs)

• Codeine Phosphate: Sourced from FDA-approved suppliers compliant with opioid manufacturing guidelines. The 54.3 mg per tablet dose aligns with DEA production quotas to prevent diversion[6][8].
• Chlorpheniramine Maleate: A first-generation antihistamine procured from bulk chemical manufacturers. Its inclusion at 8 mg per tablet provides synergistic antitussive effects[7].

Excipient Suppliers

MainPointe relies on established suppliers for inactive components:

• Hypromellose: A cellulose derivative used for extended-release matrix formation, sourced from Dow Chemical Company or similar providers[3][4].
• Lactose Monohydrate: A filler obtained from dairy-processing affiliates under GMP standards[4].

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Distribution Networks and Pharmacy Access

Retail Pharmacy Partnerships

Tuxarin ER is available at major retail chains, including CVS and Walgreens, though prior authorization requirements may apply under certain insurance plans[10][12]. MainPointe’s salesforce collaborates with distributors like McKesson and Cardinal Health to ensure nationwide availability.

Insurance Coverage Challenges

Despite its efficacy, Tuxarin ER faces coverage restrictions. For example, AmeriHealth’s Value Formulary lists it as non-preferred, requiring step therapy with dextromethorphan-based alternatives[10]. Similarly, UnitedHealthcare mandates prior authorization for patients under 65[12].

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Future Outlook and Strategic Moves

Patent Expiry and Generic Competition

With no generics currently available, MainPointe retains full market control. However, the 2030 patent cliff may invite competitors unless secondary patents covering formulation techniques are granted[2][9].

Expansion into Digital Health Tools

MainPointe’s 2021 collaboration with RepliCel to distribute injector devices signals a broader strategy to diversify its portfolio[11]. While unrelated to Tuxarin ER, this partnership enhances the company’s infrastructure for future product launches.

Acquisition of OTC Brands

MainPointe’s 2018 acquisition of Mission Pharmacal’s consumer health lines, including Thera-Gesic and Dr. Smith’s Diaper Rash Ointment, strengthens its position in adjacent markets[14][15]. These moves provide cross-promotional opportunities for Tuxarin ER in retail settings.

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Key Takeaways

1. MainPointe Pharmaceuticals is the sole manufacturer and NDA holder for Tuxarin ER, leveraging patented extended-release technology.
2. Nexgen Pharma and Spriaso LLC were critical partners in developing and commercializing the drug.
3. Regulatory exclusivity and Schedule III status underpin Tuxarin ER’s market dominance despite insurance coverage hurdles.
4. Supply chain resilience depends on FDA-compliant API sourcing and partnerships with bulk excipient suppliers.
5. Future generic competition post-2030 could disrupt MainPointe’s revenue stream unless formulation patents are extended.

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Frequently Asked Questions

1. Can I purchase generic Tuxarin ER?
No—the FDA has not approved any therapeutically equivalent generics as of March 2025[2].

2. Who should avoid Tuxarin ER?
Patients with severe asthma, bowel obstructions, or a history of opioid addiction[1][6].

3. How does Tuxarin ER differ from other cough suppressants?
Its 12-hour dosing and lower scheduling class reduce misuse risk compared to Schedule II codeine products[5][9].

4. Is Tuxarin ER covered by Medicare?
Coverage varies by plan, with many requiring prior authorization[12][13].

5. What is MainPointe’s role beyond manufacturing?
They handle regulatory compliance, distribution, and post-marketing safety monitoring[3][8].

References

1. https://www.webmd.com/drugs/2/drug-176893/tuxarin-er-oral/details
2. https://www.drugs.com/availability/generic-tuxarin-er.html
3. https://mainpointepharmaceuticals.com/tuxarin-er/
4. https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=a7cfab67-6087-4ab4-b7cd-4f9295413180
5. https://www.biospace.com/b-spriaso-b-announces-approval-of-new-drug-application-for-the-long-acting-codeine-antitussive-with-a-popular-anti-histamine
6. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/206323s004lbl.pdf
7. https://www.rxlist.com/tuxarin-er-drug.htm
8. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a7cfab67-6087-4ab4-b7cd-4f9295413180
9. https://www.globenewswire.com/news-release/2015/07/01/749018/0/en/Spriaso-Announces-Approval-of-New-Drug-Application-for-the-Long-Acting-Codeine-Antitussive-With-a-Popular-Anti-Histamine.html
10. https://amerihealth.com/pdfs/providers/pharmacy_information/value/non-formulary-drug-list.pdf
11. https://www.replicel.com/news/replicel-and-mainpointe-pharmaceuticals-sign-strategic-investment-and-collaboration-agreement
12. https://www.uhcprovider.com/content/dam/provider/docs/public/commplan/ne/pharmacy/NE-Preferred-Drug-List.pdf
13. https://www.maine.gov/pfr/sites/maine.gov.pfr/files/inline-files/2019-Q1_Formulary_2.pdf
14. https://chaindrugreview.com/mission-pharmacal-sells-otc-health-products-to-mainpointe/
15. https://practicaldermatology.com/news/mainpointe-pharmaceuticals-to-purchase-and-license-missions-consumer-products/2457868/