PROCARDIA XL Drug Patent Profile

Which patents cover Procardia Xl, and what generic alternatives are available?

Procardia Xl is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in PROCARDIA XL is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Procardia Xl

A generic version of PROCARDIA XL was approved as nifedipine by ACTAVIS ELIZABETH on January 8^th, 1991.

Summary for PROCARDIA XL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	11
Drug Prices:	Drug price information for PROCARDIA XL
DailyMed Link:	PROCARDIA XL at DailyMed

See drug prices for PROCARDIA XL

See drug sales revenues for PROCARDIA XL

Recent Clinical Trials for PROCARDIA XL

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

Sponsor	Phase
Medical College of Wisconsin	N/A
Icahn School of Medicine at Mount Sinai	Phase 4
University of Tennessee Medical Center	Early Phase 1

See all PROCARDIA XL clinical trials

Pharmacology for PROCARDIA XL

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

US Patents and Regulatory Information for PROCARDIA XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-001	Sep 6, 1989	AB2	RX	Yes	No
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-002	Sep 6, 1989	AB2	RX	Yes	No
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-003	Sep 6, 1989		DISCN	Yes	No

Expired US Patents for PROCARDIA XL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-002	Sep 6, 1989	4,327,725
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-003	Sep 6, 1989	5,264,446
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-001	Sep 6, 1989	4,327,725
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-003	Sep 6, 1989	4,783,337

International Patents for PROCARDIA XL

See the table below for patents covering PROCARDIA XL around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	15606
Germany	3172338
European Patent Office	0052917	OSMOTIC DEVICE WITH HYDROGEL DRIVING MEMBER
Japan	S5793065	PERMEATION APPARATUS HAVING HYDROGEL DRIVE MEMBER

Procardia XL (nifedipine ER) Market Dynamics and Financial Trajectory: Sales Trends, Exclusivity Timeline, Patent/Generic Pressure, and Revenue Outlook

Last updated: July 29, 2026

Executive summary: Procardia XL (nifedipine extended-release) is a mature, off-patent brand in the US with persistent generic substitution risk. Market performance is driven by (1) ongoing price compression from multiple ANDA entrants, (2) payer-driven formulary limits for dihydropyridine calcium-channel blockers, and (3) demand stability tied to hypertension and stable angina prescribing rather than new clinical adoption. Financial trajectory typically trends toward low-growth or revenue drift as share shifts to lower-cost generics and channel inventory cycles through.

What is Procardia XL and how is it positioned in the US cardiovascular drug market?

Procardia XL is an extended-release oral formulation of nifedipine, a dihydropyridine calcium-channel blocker used for hypertension and stable angina. The market structure is characteristic of older cardiovascular brands: branded revenue persists mainly where (a) prescriber familiarity and legacy contracts keep some demand, and (b) generics capture most coverage but not all.

Which therapeutic areas drive Procardia XL demand?

• Hypertension (chronic, high volume)
• Stable angina (less frequent than hypertension, but still persistent)
• Switch and maintenance therapy within calcium-channel blocker classes

How does Procardia XL compare with competing nifedipine and CCB options?

In practice, Procardia XL competes on:

• Dosing convenience and release profile versus immediate-release nifedipine and other ER CCBs
• Net price versus generic ER nifedipine and branded alternatives (where coverage allows)
• Payer preference for generic products within the class

How have Procardia XL sales behaved over time and what explains the trajectory?

Procardia XL is in the “legacy brand under generic pressure” category. The financial trajectory in markets like the US is usually shaped by:

1. Multiple generic ANDAs entering with competitive pricing
2. Plan-level formulary tiering that pushes utilization to generics
3. Lower willingness by manufacturers to support brand-level channel investment when pricing power is limited
4. Patient-level substitution for ER CCBs, where prescribers can switch within class

What are the main revenue drivers for a mature ER hypertension/angina brand?

• Market share against generic nifedipine ER
• Pharmacy benefit manager (PBM) contracting terms and rebate pressure
• Script velocity and persistence (chronic use supports baseline)
• Short-term swings from wholesaler inventory and procurement cycles

What is the Orange Book status of Procardia XL (nifedipine ER) and what does that imply for generic entry risk?

Orange Book status determines whether brand exclusivity is still active and how many ANDAs are likely to file against listed patents. For mature products, the typical outcome is:

• Patents expire or are no longer enforceable
• ANDA approvals continue under paragraph III (non-infringement) or paragraph IV (invalidity or non-infringement) theories
• Generic supply expands and drives pricing compression

What generic entry risks exist for Procardia XL?

• Continued ANDA product proliferation for ER nifedipine dosage forms
• Product switching where “therapeutic interchange” is allowed
• Increased payer sensitivity to cost in hypertension segments

(Note: a complete Orange Book-specific status table requires Orange Book patent and exclusivity listings for Procardia XL’s exact NDA strength(s) and dosage form. Without that specific Orange Book dataset in the prompt, a definitive claim-by-claim listing cannot be produced.)

When do Procardia XL patents and exclusivities expire, and when does it lose exclusivity?

For legacy nifedipine ER brands, the exclusivity endgame typically occurs years before current-day generic market dominance, leaving only:

• Late-expiring, formulation-specific patents (if any remain in force)
• Method-of-use patents for specific indications or dosing regimens (often also long expired)
• Exclusivity tied to changes in formulation or manufacturing

A complete exclusivity timeline must be grounded in:

• NDA-specific patent expiration dates
• Relevant pediatric exclusivity or other statutory exclusivities
• Any granted terminal disclaimers affecting effective expiration

(A precise date-by-date exclusivity timeline is not provided in the prompt and cannot be constructed accurately without Orange Book and FDA exclusivity data for the specific Procardia XL NDA.)

How many patents protect Procardia XL and what types of IP are most relevant?

For older cardiovascular brands, patent estates usually skew toward:

• Formulation patents (ER matrix, coatings, release control)
• Process/manufacturing method patents
• Method-of-use claims (less common for generics unless still active)
• Composition-of-matter is typically long expired for well-established APIs like nifedipine

What formulation patents matter for an ER nifedipine product?

The most litigated and most likely to block early ANDA approval tends to involve:

• Release profile control (diffusion/erosion mechanisms)
• Specific excipient systems that achieve ER characteristics
• Coating systems and granulation methods

What Procardia XL patent litigation has occurred and how did settlements affect market outcomes?

Brand-versus-ANDA disputes are common in legacy cardiovascular drugs, but determining the specific litigation record for Procardia XL requires:

• The FDA Orange Book patent numbers listed for the relevant NDA
• Court docket outcomes for each paragraph IV challenge
• Any settlement agreements that created 30-month stay effects or launch carve-outs

(The prompt does not provide the litigation docket or settlement references needed to produce a factual, case-by-case litigation timeline.)

Which companies market generic nifedipine ER that compete with Procardia XL?

Competition usually spans:

• Large generic manufacturers with ANDA ER capabilities
• Regionally strong generics with established distribution
• Multiple strengths and generic NDCs that substitute at the pharmacy counter

A defensible company list must be built from:

• ANDA approvals for the same NDA/strength/dosage form
• Orange Book or FDA publication data tied to labeled strengths

(A firm competitor roster cannot be produced without the exact strength-by-strength NDC/ANDA mapping for Procardia XL.)

How does Procardia XL compare commercially with other ER nifedipine brands and ER CCBs?

Commercial comparability is typically measured by:

• Share stability in hypertension
• Net price per script and rebate intensity
• Payer formulary tier placement
• Pharmacy switching behavior for ER CCBs

What drives substitution among ER CCBs?

• Price and rebate contracts
• Interchangeability rules at the state level
• Patient tolerance, especially for adverse events associated with CCBs (e.g., edema, headache, flushing)
• Coverage policies for “brand only” versus “generic preferred”

What is the regulatory pathway impact for Procardia XL generics (ANDA vs 505(b)(2))?

For classic off-patent oral small molecules like nifedipine ER, the generic route is typically:

• ANDA with bioequivalence to the reference listed drug

505(b)(2) would generally require a new formulation with bridging data, which is less common for straightforward ER generics when a bioequivalent generic path exists.

How do FDA bioequivalence and labeling constraints affect market entry?

• Formulation must match release characteristics sufficiently to support BE
• Labeling for indications and dosing must align with reference product labeling and any granted carve-outs

What is the financial trajectory outlook for Procardia XL through the next 3 to 5 years?

Given mature status and generic substitution mechanics, the outlook typically follows a pattern:

• Revenue continues declining or stagnating at a low level as remaining brand share erodes
• Gross-to-net pressure may remain limited if remaining volume is institutional or contracted, but price compression dominates
• Product-level discontinuation risk increases if manufacturing economics degrade due to low brand volume

A precise forward revenue forecast requires:

• Historical annual sales by year
• Current market share and net pricing by strength
• Generic penetration rates and NDC distribution data

(The prompt does not include numeric historical sales, brand share, or FDA/Orange Book data needed to generate a concrete financial model.)

Key takeaways

• Procardia XL (nifedipine ER) operates in a mature cardiovascular segment with sustained generic substitution pressure.
• Market dynamics are dominated by pricing, formulary placement, and channel inventory cycles rather than brand differentiation.
• The brand’s financial trajectory is structurally consistent with continued revenue erosion or stagnation once generic dominance is established.
• A precise exclusivity and patent timeline, Orange Book status, and litigation/settlement impacts require NDA/Orange Book patent datasets not provided in the prompt.

FAQs

1. Does Procardia XL have exclusivity or active patents that delay ANDA approval?
2. Which Orange Book patents are listed for Procardia XL and what are their expiration dates?
3. What generic nifedipine ER products can substitute for Procardia XL by NDC strength?
4. What Paragraph IV filings or court cases have affected generic launch timing for Procardia XL?
5. How do PBM formulary tiers typically affect ER nifedipine brand retention versus generic switching?

References (APA)

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration.
2. FDA. Drugs@FDA. US Food and Drug Administration.