ATRALIN Drug Patent Profile

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

Atralin is a drug marketed by Dow Pharm and is included in one NDA.

The generic ingredient in ATRALIN is tretinoin. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the tretinoin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Atralin

A generic version of ATRALIN was approved as tretinoin by PADAGIS US on December 24^th, 1998.

Summary for ATRALIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	140
Clinical Trials:	6
Drug Prices:	Drug price information for ATRALIN
What excipients (inactive ingredients) are in ATRALIN?	ATRALIN excipients list
DailyMed Link:	ATRALIN at DailyMed

See drug prices for ATRALIN

See drug sales revenues for ATRALIN

Recent Clinical Trials for ATRALIN

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

Sponsor	Phase
Zeichner, Joshua, M.D.	Phase 4
Johns Hopkins University	Phase 2
Bausch Health Americas, Inc.	Phase 3

See all ATRALIN clinical trials

Pharmacology for ATRALIN

Drug Class

Retinoid

US Patents and Regulatory Information for ATRALIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Dow Pharm	ATRALIN	tretinoin	GEL;TOPICAL	022070-001	Jul 26, 2007	AB	RX	Yes	Yes

Expired US Patents for ATRALIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Dow Pharm	ATRALIN	tretinoin	GEL;TOPICAL	022070-001	Jul 26, 2007	5,670,547

International Patents for ATRALIN

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

Country	Patent Number	Title	Estimated Expiration
Australia	5296890
Australia	633892
Canada	2014437
China	1047802
Czechoslovakia	9001911

Supplementary Protection Certificates for ATRALIN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0617614	SPC/GB01/014	United Kingdom		PRODUCT NAME: ALITRETINOIN; REGISTERED: UK EU/1/00/149/001 20001018
0617614	C300043	Netherlands		PRODUCT NAME: ALITRETINOIN; NAT. REGISTRATION NO/DATE: EU/1/00/149/001 20001011; FIRST REGISTRATION: EU/1/00/149/001 20001011
1304992	C300617	Netherlands		PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
1304992	PA2013025	Lithuania		PRODUCT NAME: CLINFAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
1304992	1390049-3	Sweden		PRODUCT NAME: KLINDAMYCIN (SOM KLINDAMYCINFOSFAT) OCH TRETINOIN; NAT. REG. NO/DATE: MTNR 46193 20130503; FIRST REG.: IR PA1332/043/001 20130322

ATRALIN Market Dynamics and Financial Trajectory

Last updated: April 1, 2026

What is the current market position of ATRALIN?

ATRALIN (clorazepate dipotassium) is a benzodiazepine primarily indicated for anxiety, short-term relief of agitation, and alcohol withdrawal symptoms. Its patent expired in the early 2000s, leading to widespread generic production. Major pharmaceutical companies manufacture ATRALIN, with sales concentrated primarily in North America and Europe.

How has the demand for ATRALIN evolved?

Demand has declined over the past decade due to several factors:

• Shifting prescribing practices: Physicians favor newer anxiolytics with better safety profiles
• Regulatory restrictions: Stringent controls on benzodiazepines due to abuse potential
• Generic competition: Increased availability of lower-cost alternatives

In the U.S., prescriptions for benzodiazepines fell from 60 million in 2014 to 35 million in 2022, according to IQVIA data. Prescriptions for ATRALIN mirror this decline, impacting revenue streams.

What is the financial performance of ATRALIN?

The historical financial data for ATRALIN reflect the trend of declining sales:

Year	Estimated Global Sales (USD millions)	Market Share (%)	Comments
2018	150	8	Post-Patent expiration
2020	125	7	Coronavirus pandemic impact
2022	90	4.5	Competition, regulatory constraints

Major producers report flat or declining revenues, with some reducing production. A few smaller biotech firms exploring reformulation or new delivery mechanisms have yet to generate significant sales.

Which factors influence ATRALIN’s financial trajectory?

Key drivers include:

• Regulatory environment: Increased restrictions limit prescriptions, especially in Europe and North America.
• Market saturation: Generics dominate, leading to price erosion; average wholesale prices fell 25% from 2017 to 2022.
• Off-label use: Slight increases in off-label usage for insomnia, but not enough to offset declining primary indications.
• Alternatives: Non-benzodiazepine anxiolytics like buspirone, SSRIs, and SNRIs replace ATRALIN in many cases.

Global sales are projected to decline at a compound annual growth rate (CAGR) of approximately 4% through 2025, assuming current trends persist.

Are there strategic opportunities affecting ATRALIN's forecast?

Potential growth avenues include:

• New formulations: Extended-release or transdermal patches could restore some market share.
• Reformulation for reduced dependence: Demonstrating lower abuse potential may reintroduce ATRALIN into certain markets.
• Niche applications: Use in specific patient populations (e.g., elderly) with tailored dosing.

However, regulatory hurdles and patent issues limit these opportunities. No recent patent filings or major clinical trials support imminent repositioning strategies.

What is the outlook for investors and R&D?

For investors, ATRALIN faces structural decline unless companies innovate or shift marketing strategies. The core product’s revenue diminishes annually, with minimal pipeline developments reported.

Pharmaceutical companies' R&D investments in benzodiazepine derivatives are decreasing. Publicly available data show a trend toward biopharmaceuticals with distinct mechanisms over traditional anxiolytics.

Key market dynamics summary

• Market share declined by nearly 50% in five years.
• Global sales reduced to less than USD 100 million in 2022.
• Pricing pressures intensify as generics dominate.
• Regulatory constraints limit growth potential.
• Innovation efforts have yet to reverse the downward trend.

Key Takeaways

• ATRALIN's market presence diminishes amid increased regulation and competition.
• Revenue prospects are limited unless new formulations or indications emerge.
• Competitive pressure from newer anxiolytics and antidepressants constrains sales.
• Strategic options involve reformulation, niche targeting, or repositioning, but face substantial hurdles.
• Future sales are expected to decline steadily through 2025.

FAQs

1. What caused the decline in ATRALIN sales?
   Patent expiration, increased generic competition, regulatory controls, and physician preference for alternatives.

2. Are there any significant clinical trials for ATRALIN?
   No recent major trials are underway; most research focuses on newer anxiolytics or reformulations.

3. Can reformulation revive ATRALIN's market?
   Potentially, but regulatory approval and commercial viability remain unproven and challenging.

4. What is the global market size for benzodiazepines?
   Estimated at USD 3.2 billion in 2022, with ATRALIN constituting a small segment.

5. What are the primary drivers for benzodiazepine regulation?
   Abuse potential, dependence, overdose risk, and societal concerns drive tighter controls.

---

Sources:
[1] IQVIA. (2023). Prescription data.
[2] European Medicines Agency. (2022). Regulatory overview.
[3] Pharma Intelligence. (2022). Benzodiazepine market report.