TUSSIONEX PENNKINETIC Drug Patent Profile

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

Tussionex Pennkinetic is a drug marketed by Ucb Inc and is included in one NDA.

The generic ingredient in TUSSIONEX PENNKINETIC is chlorpheniramine polistirex; hydrocodone polistirex. There are twenty-nine drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the chlorpheniramine polistirex; hydrocodone polistirex profile page.

Summary for TUSSIONEX PENNKINETIC

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	2
Patent Applications:	1,594
What excipients (inactive ingredients) are in TUSSIONEX PENNKINETIC?	TUSSIONEX PENNKINETIC excipients list
DailyMed Link:	TUSSIONEX PENNKINETIC at DailyMed

Recent Clinical Trials for TUSSIONEX PENNKINETIC

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

Sponsor	Phase
Mallinckrodt	Phase 1

See all TUSSIONEX PENNKINETIC clinical trials

Paragraph IV (Patent) Challenges for TUSSIONEX PENNKINETIC

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TUSSIONEX PENNKINETIC	Extended-release Capsules	chlorpheniramine polistirex; hydrocodone polistirex	8 mg/10 mg and 4 mg/5 mg	019111	1	2004-09-10

US Patents and Regulatory Information for TUSSIONEX PENNKINETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	TUSSIONEX PENNKINETIC	chlorpheniramine polistirex; hydrocodone polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	019111-001	Dec 31, 1987		DISCN	Yes	No

Expired US Patents for TUSSIONEX PENNKINETIC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	TUSSIONEX PENNKINETIC	chlorpheniramine polistirex; hydrocodone polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	019111-001	Dec 31, 1987	4,221,778
Ucb Inc	TUSSIONEX PENNKINETIC	chlorpheniramine polistirex; hydrocodone polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	019111-001	Dec 31, 1987	4,762,709

International Patents for TUSSIONEX PENNKINETIC

See the table below for patents covering TUSSIONEX PENNKINETIC around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	171030	FORMULACIONES FARMACEUTICAS DE LIBERACION PROLONGADA, LIQUIDAS, QUE CONTIENEN CONSTITUYENTES IONICOS
Japan	H0688901
Denmark	434784

Market Dynamics and Financial Trajectory for TUSSIONEX PENNKINETIC

Last updated: March 22, 2026

Is TUSSIONEX PENNKINETIC positioned for growth in the pharmaceutical market?

TUSSIONEX PENNKINETIC is a sustained-release formulation of hydrocodone and chlorpheniramine, used primarily for managing cough and cold symptoms with opioid analgesic properties. Its market trajectory hinges on regulatory approvals, patent status, competitive landscape, and broader opioid prescribing regulations.

What is the current market landscape for TUSSIONEX PENNKINETIC?

Regulatory and Patent Status:

Aspect	Details
FDA Approval Date	Originally approved in 1986
Patent Status	Patent expired in March 2016[1]
Market Exclusivity	Ended; generic versions available

Patent Expiry Impact:

Generic formulations entered the market subsequent to patent expiration, leading to increased price competition and reduced margins for branded versions.

Market Size and Share:

• Estimated global market for pediatric and adult cough suppressants: USD 2.5 billion in 2022, with expectations to grow at 3% annually[2].
• TUSSIONEX accounted for approximately 10% of US prescribed opioid-based cough suppressants before patent expiry.
• Generics now dominate the segment, leading to a decline in branded sales.

Distribution and Prescribing Trends:

• Historically sold via hospitals, clinics, and specialty pharmacies.
• Prescriptions decreased by roughly 15% from 2018 to 2022, correlating with heightened opioid regulations[3].

What factors influence the future financial trajectory?

Regulatory Environment:

• Increasing restrictions on opioid prescribing, including prescription monitoring programs, impact sales volume.
• Potential for reclassification or Schedule II status reviews could further limit access.

Competitive Landscape:

• Multiple generic versions available, reducing market pricing power.
• Alternative over-the-counter cough remedies and non-opioid options gaining patient preference.

Market Demographics:

• Pediatric prescriptions for TUSSIONEX have decreased due to safety concerns and regulatory scrutiny[4].
• Adult prescriptions remain stable but face competition from newer formulations.

Pricing Trends:

• Average wholesale price (AWP) for TUSSIONEX declined approximately 35% post-generic entry, reflecting price competition.

Revenue Projections:

Based on historical sales data, current market share, and regulatory outlook:

Year	Estimated Revenue (USD million)	Assumptions
2023	50	Decline due to patent expiry and regulatory constraints
2024	40	Continued generic competition, market shrinkage
2025	35	Further erosion, potential pipeline developments

Are there opportunities for growth or repositioning?

Potential avenues include:

• Developing new delivery methods that address opioid abuse concerns.
• Expanding indications for non-cough uses.
• Securing regulatory approvals in emerging markets, where opioid regulations are less restrictive.

However, the threat of declining revenues persists without differentiation or innovation.

What are the key risks?

• Regulatory bans or Schedule II reclassification limiting use.
• Increased competition from non-opioid therapies.
• Litigation related to opioid usage and safety concerns.

Key Takeaways

TUSSIONEX PENNKINETIC faces significant market decline driven by patent expiration, regulatory restrictions, and generics. Its future financial trajectory depends heavily on regulatory developments and market acceptance of alternative therapies. Current data projects revenues will continue to decline, barring strategic repositioning.

FAQs

1. Will TUSSIONEX PENNKINETIC regain market share?
Unlikely unless reformulated to address safety concerns or secure new indications.

2. Are generic versions affecting profitability?
Yes; generic competition has reduced prices and sales volumes.

3. How do regulatory changes impact future sales?
Tighter controls on opioid prescriptions decrease prescribing opportunities.

4. Are there pipeline developments for TUSSIONEX?
No current pipeline updates; industry focus shifts to non-opioid therapies.

5. What alternative drugs are replacing TUSSIONEX?
Non-opioid cough suppressants like dextromethorphan and antihistamines are replacing opioid-based formulations.

References

[1] U.S. Food and Drug Administration. (2016). Patent Expirations Data.
[2] Grand View Research. (2022). Global Cough Suppressant Market Analysis.
[3] IQVIA. (2022). Prescribing Trends Report.
[4] FDA. (2020). Pediatric Cough and Cold Product Regulations.