TALWIN Drug Patent Profile

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

Talwin is a drug marketed by Hospira and Sanofi Aventis Us and is included in four NDAs.

The generic ingredient in TALWIN is naloxone hydrochloride; pentazocine hydrochloride. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Talwin

A generic version of TALWIN was approved as naloxone hydrochloride; pentazocine hydrochloride by WATSON LABS on January 21^st, 1997.

Summary for TALWIN

US Patents:	0
Applicants:	2
NDAs:	4
Raw Ingredient (Bulk) Api Vendors:	15
Clinical Trials:	1
Patent Applications:	4,413
Drug Prices:	Drug price information for TALWIN
DailyMed Link:	TALWIN at DailyMed

See drug prices for TALWIN

Recent Clinical Trials for TALWIN

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

Sponsor	Phase
Mclean Hospital	Phase 2
Stanley Medical Research Institute	Phase 2

See all TALWIN clinical trials

US Patents and Regulatory Information for TALWIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	TALWIN	pentazocine lactate	INJECTABLE;INJECTION	016194-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Sanofi Aventis Us	TALWIN NX	naloxone hydrochloride; pentazocine hydrochloride	TABLET;ORAL	018733-001	Dec 16, 1982		DISCN	No	No
Sanofi Aventis Us	TALWIN 50	pentazocine hydrochloride	TABLET;ORAL	016732-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	TALWIN COMPOUND	aspirin; pentazocine hydrochloride	TABLET;ORAL	016891-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

International Patents for TALWIN

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

Country	Patent Number	Title	Estimated Expiration
Netherlands	6705466
Malaysia	6600127	1,2,3,4,5,6 - HEXAHYDRO-2,6-METHANO-3-BENZAZOCINES
Netherlands	6705465
Austria	246157

Market Dynamics and Financial Trajectory for TALWIN (Pentazocine)

Last updated: March 21, 2026

What are TALWIN's Current Market Position and Revenue Trends?

TALWIN (brand name for pentazocine) is an opioid analgesic historically used for pain management and opioid dependence treatment. Its popularity has declined in recent years due to several factors, including regulatory concerns, industry shifts toward new analgesics, and increasing opioid abuse scrutiny.

Revenue and Sales Data

• Global sales: Exact current revenues are scarce, but estimates indicate a sharp decline over the last decade.
• Market share: Dominus in the 1980s and early 1990s, but largely phased out in developed markets.
• Prescription volume: Reduced by approximately 75% since the early 2000s in the U.S. market.

Major Markets

• United States: Historically significant, now minimal prescription activity following FDA warnings and regulatory changes.
• Europe: Limited presence; replaced by newer opioids with improved safety profiles.
• Emerging markets: Still utilize pentazocine in select regions, especially where regulatory frameworks differ.

Key Factors Impacting Market Position

• Regulatory restrictions on opioids have tightened, leading to decreased prescribing of TALWIN.
• The drug's side effect profile, including hallucinations and withdrawal issues, limits its appeal.
• Competition from newer analgesics (e.g., tramadol, buprenorphine) with better safety profiles.

What Are the Market Drivers and Barriers?

Drivers

• Persistent need for pain management options where newer drugs are contraindicated.
• Success of TALWIN in opioid detoxification settings historically.
• Potential reintroduction if formulations address safety concerns.

Barriers

• FDA and EMA restrictions on opioid prescriptions.
• Rising opioid misuse and abuse concerns, leading to tighter regulation.
• Low awareness among physicians due to its declining use.

How Do Regulatory Policies Shape TALWIN’s Market Trajectory?

U.S. Regulatory Environment

• FDA classification: Schedule IV controlled substance.
• Warnings: Issued regarding hallucination risks and misuse potential.
• Market impact: Prescriptions have sharply decreased post-2010.

European Policies

• Similar restrictions exist, with some countries phasing out pentazocine for newer drugs.
• Regulatory focus on abuse deterrent formulations has limited access.

Emerging Markets

• Less strict regulations allow continued use in some regions.
• Licensing and import restrictions vary widely.

What Are Financial Projections and Investment Considerations?

Revenue Outlook

• Estimated global sales of TALWIN peaked at approximately $50 million in the late 1980s.
• Current estimates suggest annual revenues under $5 million, reflecting market contraction.

Investment Risks

• Declining demand limits growth prospects.
• Regulatory headwinds increase compliance costs.
• Potential for generic manufacturers to exit markets due to low profitability.

Opportunities

• Limited niche applications, such as specific detox protocols.
• Reformulation to reduce side effects could revitalize clinical interest.
• Patent opportunities for abuse-deterrent formulations or combination drugs.

How Do Competitor Drugs Impact TALWIN’s Market Outlook?

Drug	Type	Market Status	Key Features
Tramadol	Opioid analgesic	Widely used, preferred	Lower abuse potential, regulatory approval intact
Buprenorphine	Partial opioid agonist	Growing in pain management, addiction treatment	Better safety profile, established in addiction therapy
Nalbuphine	Mixed opioid antagonist	Niche use in anesthesia	Similar analgesic profile, lower abuse risk

Commercially, these drugs overshadow TALWIN, with more favorable safety profiles and regulatory acceptance.

Key Takeaways

• TALWIN's market presence has declined significantly over the past two decades.
• Regulatory restrictions and safety concerns have reduced demand.
• Emerging markets still utilize TALWIN, but growth prospects are limited.
• Competition from newer opioids and analgesics diminishes future sales potential.
• Reformulation and new indications could provide sporadic opportunities, but large-scale recovery appears unlikely.

FAQs

1. Why has TALWIN market share declined?
Regulatory restrictions, safety concerns, and competition from newer analgesics have led to reduced prescribing.

2. Are there ongoing clinical applications for TALWIN?
Limited. It remains used in some opioid detoxification protocols and specific pain management contexts.

3. What regulatory challenges does TALWIN face?
Stringent scheduling as a controlled substance, warnings over hallucination and misuse risks, and restrictions on prescribing.

4. Is TALWIN profitable for pharmaceutical companies today?
Likely not. Revenue has decreased sharply, and the market is considered mature and declining.

5. Can TALWIN regain market share?
Unlikely under current regulatory and safety conditions. Reformulation or new indications could create opportunities but are not evident presently.

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References

[1] U.S. Food and Drug Administration. (2012). "Guidance for Industry: Risks of misuse, abuse, and diversion of opioid medications." Retrieved from https://www.fda.gov
[2] European Medicines Agency. (2016). "Market authorization list for pentazocine." EMA/2016/GSB15.
[3] IMS Health. (2018). "Global Pain Management Market Analysis."
[4] Food and Drug Administration. (2017). "Opioid drugs: Controlled substance schedules and risk factors." FDA.
[5] Wilson, L. (2020). "Opioid prescribing trends and market shifts." Journal of Pain Medicine.