DETROL LA Drug Patent Profile

Which patents cover Detrol La, and what generic alternatives are available?

Detrol La is a drug marketed by Upjohn and is included in one NDA.

The generic ingredient in DETROL LA is tolterodine tartrate. There are twenty-three drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the tolterodine tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Detrol La

A generic version of DETROL LA was approved as tolterodine tartrate by IVAX SUB TEVA PHARMS on February 23^rd, 2015.

Summary for DETROL LA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	16
Patent Applications:	56
Drug Prices:	Drug price information for DETROL LA
Drug Sales Revenues:	Drug sales revenues for DETROL LA
What excipients (inactive ingredients) are in DETROL LA?	DETROL LA excipients list
DailyMed Link:	DETROL LA at DailyMed

See drug prices for DETROL LA

See drug sales revenues for DETROL LA

Recent Clinical Trials for DETROL LA

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

Sponsor	Phase
University of California, San Francisco	Phase 4
Astellas Scientific & Medical Affairs, Inc.
Astellas Pharma Global Development, Inc.	Phase 4

See all DETROL LA clinical trials

Pharmacology for DETROL LA

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Paragraph IV (Patent) Challenges for DETROL LA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DETROL LA	Extended-release Capsules	tolterodine tartrate	2 mg and 4 mg	021228	1	2007-07-30

US Patents and Regulatory Information for DETROL LA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-001	Dec 22, 2000	AB	RX	Yes	No
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-002	Dec 22, 2000	AB	RX	Yes	Yes

Expired US Patents for DETROL LA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-002	Dec 22, 2000	6,911,217*PED
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-001	Dec 22, 2000	6,911,217*PED
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-002	Dec 22, 2000	6,770,295*PED

International Patents for DETROL LA

See the table below for patents covering DETROL LA around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	200202767	Pharmaceutical formulation containing tolterodine and its use.
Norway	20022264
Finland	109900

Supplementary Protection Certificates for DETROL LA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0325571	21/1998	Austria		PRODUCT NAME: TOLTERODIN, SEINE SALZE, RACEMATE UND ENANTIOMERE; NAT. REGISTRATION NO/DATE: 1-22389 UND 1-22390 19980210; FIRST REGISTRATION: SE 13475 UND 13476 19970905
0325571	SPC/GB98/027	United Kingdom		PRODUCT NAME: TOLTERODINE OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: SE 13475 19970905; SE 13476 19970905; UK 00032/0222 19980203; UK 00032/0223 19980203
0325571	C980020	Netherlands		PRODUCT NAME: TOLTERODINE, DESGEWENST IN DE VORM VAN EEN ZOUT MET EEN FYSIOLO GISCH ACCEPTABEL ZUUR, IN HET BIJZONDER TOLTERODINE L-TARTRAAT; NAT. REGISTRATION NO/DATE: RVG 22148, RVG 22149 19980217; FIRST REGISTRATION: SE 13475, 13476 19970905

DETROL LA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DETROL LA

Overview of DETROL LA

DETROL LA, a brand name for the drug tolterodine tartrate, is a medication used to treat overactive bladder (OAB) symptoms such as frequent urination, urgent need to urinate, and incontinence. Here’s a detailed look at the market dynamics and financial trajectory of DETROL LA.

Market Dominance and Decline

DETROL LA has historically been a dominant player in the overactive bladder market. However, its market share began to decline significantly in mid-2009. This decline was largely due to Pfizer's strategic decision to shift promotional efforts from DETROL LA to its new drug, Toviaz, which was launched in March 2009[4].

Impact of Promotional Shift

Pfizer's decision to promote Toviaz over DETROL LA led to a noticeable drop in DETROL LA's prescriptions. Despite Toviaz being structurally similar to DETROL LA, it failed to replicate the success of its predecessor. By January 2012, Toviaz accounted for only 4% of the market prescriptions, while DETROL LA's share continued to decline[4].

Generic Competition

The overactive bladder market is highly competitive, with generics playing a significant role. Drugs like Ditropan and Ditropan XL are already available as generics, and more are expected to enter the market as patents expire. The impending loss of patent protection for DETROL LA further threatens its market share[4].

Financial Performance

In 2007, DETROL LA's new prescription share declined by 3.4% to a 39.5% market share. This decline reflected in Pfizer's financial reports, where the revenue from DETROL LA was impacted by the promotional shift and increasing generic competition[5].

Revenue Impact

Pfizer's revenue from DETROL LA decreased as the drug's market share declined. The company's overall revenue from primary care products, which include DETROL LA, saw a decline of 10% in the fourth quarter of 2013 and 15% for the full year compared to the previous year[2].

Market Sales

In the 12 months ending January 2012, the overactive bladder market saw over 17.8 million prescriptions filled, generating almost $2.1 billion in sales. However, DETROL LA's share of these prescriptions was decreasing, while other drugs like VESIcare and generics were gaining ground[4].

Regulatory and Clinical Aspects

DETROL LA has undergone significant regulatory scrutiny. For instance, Pfizer conducted online clinical trials in 2011 to gather data on the safety and efficacy of DETROL LA, which were reviewed by the FDA. These trials were part of Pfizer's efforts to ensure the drug's continued approval and market presence[1].

Future Market Dynamics

The future of the overactive bladder market is expected to be dynamic, with several factors influencing DETROL LA's trajectory:

• Generic Entries: More generics are expected to enter the market, further eroding DETROL LA's market share.
• New Drug Launches: The potential approval of new drugs like mirabegron could shift market dynamics and patient preferences.
• Marketing Strategies: Companies like Astellas may choose to focus on new products or continue promoting existing ones, affecting the competitive landscape[4].

Financial Projections and Challenges

The financial performance of DETROL LA is likely to continue facing challenges:

• Revenue Decline: Continued decline in prescriptions and revenue due to generic competition and promotional shifts.
• Regulatory Hurdles: Rigid regulatory policies and potential side effects associated with the drug could impact its market position.
• Cost and Reimbursement: High costs and poor reimbursement frameworks may further hinder the drug's financial performance[1].

Key Takeaways

• DETROL LA's market dominance has declined significantly since 2009 due to Pfizer's promotional shift to Toviaz.
• Generic competition and the loss of patent protection are major threats to DETROL LA's market share.
• The drug's financial performance has been impacted by declining prescriptions and revenue.
• Future market dynamics will be influenced by new drug launches, generic entries, and marketing strategies.

FAQs

What is DETROL LA used for?

DETROL LA is used to treat overactive bladder symptoms such as frequent urination, urgent need to urinate, and incontinence.

Why did DETROL LA's market share decline?

DETROL LA's market share declined due to Pfizer's decision to shift promotional efforts to its new drug, Toviaz, and the increasing presence of generic competitors.

What is the impact of generic competition on DETROL LA?

Generic competition, particularly from drugs like Ditropan and Ditropan XL, has significantly eroded DETROL LA's market share and is expected to continue doing so as more generics enter the market.

How has Pfizer's financial performance been affected by DETROL LA's decline?

Pfizer's revenue from primary care products, including DETROL LA, has seen a decline due to the drop in prescriptions and market share of DETROL LA.

What are the future challenges for DETROL LA in the market?

Future challenges include the entry of new generics, the potential approval of new drugs like mirabegron, and ongoing regulatory and cost-related hurdles.

Sources

1. Data Bridge Market Research - Global Tolterodine Market - Industry Trends and Forecast to 2028
2. Pfizer - Pfizer Reports Fourth-Quarter and Full-Year 2013 Results
3. GSK - GSK Annual Report 2007
4. PM360 - Overactive Bladder Market: Managing the Future
5. Pfizer Inc. - 2007 Financial Report - Annual Reports