PLENDIL Drug Patent Profile

Which patents cover Plendil, and when can generic versions of Plendil launch?

Plendil is a drug marketed by Astrazeneca and is included in one NDA.

The generic ingredient in PLENDIL is felodipine. There are seventeen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the felodipine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Plendil

A generic version of PLENDIL was approved as felodipine by GLENMARK PHARMS LTD on December 17^th, 2010.

Summary for PLENDIL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	120
Clinical Trials:	4
Patent Applications:	4,547
DailyMed Link:	PLENDIL at DailyMed

Recent Clinical Trials for PLENDIL

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

Sponsor	Phase
Lawson Health Research Institute	Phase 1
Ranbaxy Laboratories Limited	N/A
LanZhou University	Phase 4

See all PLENDIL clinical trials

US Patents and Regulatory Information for PLENDIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-004	Sep 22, 1994		DISCN	Yes	No
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-001	Jul 25, 1991		DISCN	Yes	No
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-002	Jul 25, 1991		DISCN	Yes	No

International Patents for PLENDIL

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

Country	Patent Number	Title	Estimated Expiration
Austria	1237
Australia	4831679
Australia	529116
Bulgaria	61420
Canada	1117530	3,5-DIESTERS ASSYMETRIQUES DE 2,6-DIMETHYL-4-2,3- PHENYL DISUBSTITUE-1,4-DIHYDROPYRIDINE-3,5-ACIDE DICARBOXYLIQUE, AYANT DES PROPRIETES D'HYPOTENSEURS; METHODE DE PREPARATION, ET PREPARATION PHARMACEUTIQUE A BASE DE CES PRODUITS (2,6-DIMETHYL-4-2,3-DISUBSTITUTED PHENYL-1,4- DIHYDROPYRIDINE-3,5-DICARBOXYLIC ACID-3,5-ASYMMETRIC DIESTERS HAVING HYPOTENSIVE PROPERTIES AS WELL AS PROCESS FOR THEIR PREPARATIONAND PHARMACEUTICAL PREPARATION CONTAINING SAME)
Czechoslovakia	241021	METHOD OF 2,6-DIMETHYL-4-(I8O-DICHLOROPHENYL)-1,4-DIHYDROPYRIDINE-3,5-DICARBOXYL ACID'S 3-METHYL-5-ETHYLESTER PRODUCTION

Supplementary Protection Certificates for PLENDIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0007293	SPC/GB93/134	United Kingdom
0007293	95C0001	Belgium		PRODUCT NAME: FELODIPINE, METOPOLOL SUCCINATE; NAT. REGISTRATION NO/DATE: 122 IS 160 F 3 / 19921230; FIRST REGISTRATION: DK 8678 19921230
0265685	SPC/GB98/047	United Kingdom		PRODUCT NAME: COMBINATIONS OF RAMIPRIL, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, AND FELODIPINE, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: SE 13596 19970919; SE 13597 19970919; UK 00017/0402 19980825; UK 00017/0403 19980825
0265685	C980030	Netherlands		PRODUCT NAME: FELODIPINE, DESGEWENST IN DE VORM VAN FYSIOLOGISCH AANVAARDBAAR ZOUT, EN (2S, 3AS, 6AS)-1-[(S)-N-[(S)-1-CARBOXY-3-FENYLPROPYL]A LANYL]OCTAHYDROCYCLOPENTA[B]-PYRROOL-2-CARBONZUUR (RAMIPRILAAT) , DESGEWENST IN DE VORM VAN EEN .....ZIE VERDER IN HET DOSSIER; NAT. REGISTRATION NO/ DATE: RVG 22449, RVG 22450 19980618; FIRST REGISTRATION: SE 13596, 13597 19970919

PLENDIL (felodipine) market dynamics and financial trajectory: pricing, volume, competition, and exclusivity risk

Last updated: July 6, 2026

Executive summary: PLENDIL (felodipine) remains a generic-dominated, lower-margin cardiovascular drug with limited ongoing patent-driven market protection in most jurisdictions. Financial trajectory is driven by (1) the maturity of the felodipine class, (2) payer-driven price compression and multiple generic suppliers, (3) ongoing substitution within antihypertensives, and (4) dosing-form specific dynamics around extended-release (ER) and local regulatory/branding. Net revenue growth, where it occurs, is typically volume-led and constrained by competitive entry and formulary position rather than by exclusivity.

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Is PLENDIL felodipine extended-release or immediate-release, and how does that shape its market?

Featured snippet answer: PLENDIL is marketed as felodipine extended-release (ER), which supports once-daily adherence and smoother pharmacokinetics versus immediate-release products. Market access and substitution decisions often hinge on whether a generic has bioequivalent ER performance and labeling alignment.

Formulation-specific switching: what typically determines prescriber and payer behavior

• Bioequivalence and ER release profile: Payers and pharmacy chains tend to substitute based on AB-rated generics for the same dosage form and strength.
• Dose-strength coverage: Revenue tends to concentrate in the strength-and-dose patterns that match the most common titration pathways in real-world hypertension regimens.
• Substitution rules: In many markets, ER branded products face faster substitution once generics are established, because pharmacists can dispense therapeutically equivalent alternatives at lower acquisition cost.

Therapeutic positioning that affects commercial durability

Felodipine is a calcium channel blocker used primarily for hypertension. Commercial trajectory is typically tied to:

• the overall antihypertensive prescribing environment,
• the competitive set within calcium channel blockers (CCBs) and other first-line classes,
• payer step edits and preferred formulary lists.

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What is the PLENDIL revenue trajectory and what typically drives growth or decline?

Featured snippet answer: Revenue typically declines post-brand maturity and follows a plateau or downward slope once multiple generics become standard-of-care for felodipine ER. Any short-term improvements are usually due to channel mix shifts (hospital vs retail), temporary price stabilizations, or local supply dynamics.

Key market drivers that determine financial trajectory

1. Generic price erosion

   • After generic entry, pricing generally tracks local tender outcomes and pharmacy acquisition cost pressure.
   • Brand revenue tends to fall to a low share as payers move to preferred generic status.

2. Formulary status

   • Commercial durability depends on whether PLENDIL retains preferred status or is demoted to non-preferred with prior authorization or step therapy for brand.
   • In mature markets, felodipine ER is often treated as a commodity within CCBs.

3. Dose mix and adherence

   • ER products can maintain share better than IR where once-daily adherence is valued.
   • If ER AB-rated alternatives are widely available, ER advantage shifts from brand to generic.

4. Regional supply and procurement

   • Tendering cycles and supplier concentration can temporarily stabilize market prices.
   • Long-term dynamics usually revert to competitive equilibrium.

What “financial trajectory” looks like for branded felodipine ER in practice

• Early life: brand pricing premium, limited generic pressure.
• Mid-cycle: first generics reduce brand share; revenue declines unless PLENDIL stays preferred.
• Late-cycle: deep generic competition with minimal remaining pricing leverage; revenue becomes small relative to category and is dominated by the lowest net cost suppliers.

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When do PLENDIL (felodipine) exclusivity and patent protections typically end, and what does that mean for pricing?

Featured snippet answer: For older small-molecule cardiovascular brands like PLENDIL, most meaningful exclusivity typically occurs decades earlier through primary composition and formulation patents, plus any regulatory exclusivities. The commercial effect is straightforward: when protections expire and generics enter, price compression accelerates and the brand’s remaining sales are largely contingent on formulary preference and patient/prescriber inertia.

How exclusivity expiration translates into market mechanics

• Patent expiry: generic entry accelerates and shifts volume from brand to AB-rated alternatives.
• Launch timing and supply ramp: early generic entrants often capture the fastest share if they secure broad distribution and tender competitiveness.
• Parallel switches: once pharmacy-level substitution is routine, branded share erodes quickly.

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What does the competitive landscape for felodipine ER look like after generic entry?

Featured snippet answer: The post-entry market is typically characterized by multiple AB-rated generic manufacturers, with price competition and tendering determining the leading suppliers in each geography.

Competitor set structure

• Direct equivalents: felodipine ER tablets/capsules at matching strengths.
• Therapy substitutes: other CCBs (e.g., amlodipine, nifedipine ER) and other antihypertensives (ACE inhibitors, ARBs, thiazide-like diuretics) depending on local guideline preferences.

Implications for share and margins

• Generic compression: gross margin for felodipine ER branded SKUs collapses once generic share dominates.
• Brand-specific exceptions: only persist where brand remains preferred or where generic substitution is restricted.

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How do payer and channel dynamics affect PLENDIL market access and financial performance?

Featured snippet answer: PLENDIL’s financial performance is usually determined more by payer contracting and formulary status than by clinical differentiation, because felodipine ER competes in a mature cardiovascular class with broad generic availability.

Payer contracting patterns

• Preferred generic lists: cost-minimizing formularies choose the lowest net cost AB-rated product.
• Switching policies: formulary switches and step edits reduce brand retention.
• Budget impact thresholds: small CCB cost deltas can still drive formulary wins in large payer books.

Channel and geography

• Retail: rapid switching after pharmacy substitution becomes entrenched.
• Hospital: procurement tenders can concentrate volume to a few suppliers, but hospital demand for antihypertensives is typically split among multiple agents.

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What generic entry risks exist for PLENDIL, and how do they alter forward-looking revenue?

Featured snippet answer: In a mature small-molecule category, the main generic entry risks are tied to additional generic approvals, new label strengths, and manufacturing changes that re-open competitive tenders rather than to new novel products.

Where revenue risk usually concentrates

• Strength-level competition: if additional generic strengths launch, the brand can lose pockets of mix.
• National tender rounds: can re-price the entire product cohort and reset net revenue.
• Supply disruptions: short-term brand lift can occur when preferred generics are unavailable, but it typically reverses when supply normalizes.

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What formulation patents and manufacturing/IP barriers matter most for felodipine ER competition?

Featured snippet answer: The decisive barriers for felodipine ER commercialization are usually formulation-specific (release-control, excipient systems) and manufacturing process know-how, but once multiple AB-rated products are on the market, these barriers tend to be commercially weak.

Common IP and regulatory friction points in ER generics

• ER release mechanism reproducibility: small differences can affect dissolution profiles, but AB bioequivalence standards usually allow substitution once approved.
• Manufacturing scale-up: process robustness affects launch speed and batch acceptance.

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What Orange Book or FDA regulatory status would be expected for PLENDIL, and why it matters?

Featured snippet answer: For an older antihypertensive like felodipine ER, FDA status typically shows a mature ecosystem of ANDA approvals and AB-rated generics, which drives rapid substitution and pricing compression. The operational significance is that branded incremental revenue is usually limited to remaining formulary preference.

Regulatory pathway dynamics

• Brand NDA: continued on-market presence is often small relative to generic volumes.
• ANDAs: approval density and listing maturity predict the speed and depth of competitive erosion.

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How does PLENDIL compare with other antihypertensives on commercialization resilience?

Featured snippet answer: Felodipine ER generally has lower commercialization resilience than on-patent or specialty antihypertensives because it faces both (1) generic felodipine competition and (2) substitution across multiple antihypertensive classes.

Competitive resilience drivers vs weaker drivers

• Stronger resilience: if a product has differentiated dosing convenience, limited therapeutic substitutes, or protected formulation.
• Weaker resilience: mature CCB category, widespread AB substitution, aggressive tender pricing.

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Key commercial metrics investors typically track for PLENDIL-style mature generics

Featured snippet answer: For mature felodipine ER, the critical metrics are not peak growth but market share, net price, and supply/tender positioning.

Practical KPI set

• Unit volume trend: indicates whether share is being held against AB competitors.
• Net sales and net price: reveals whether pricing compresses faster than volume.
• Channel mix: retail vs institutional changes can swing quarter-to-quarter results.
• Contracting outcomes: tender wins/losses, payer formulary tier changes.

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Key takeaways

• PLENDIL’s market dynamics are consistent with a mature small-molecule antihypertensive: high generic penetration and payer-driven price compression.
• Financial trajectory is primarily shaped by formulary position, tender economics, and dosing-form substitution, not by ongoing exclusivity.
• Forward-looking revenue risk is dominated by continued generic supply expansion and renewed tender price resets, with only intermittent offsets from supply disruptions or brief procurement pauses.

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FAQs

1. How quickly does a branded felodipine ER product lose share after generic entry?
2. Do ER felodipine generics lose share when pharmacists can substitute across CCBs like amlodipine?
3. What tender and procurement levers most affect net price for felodipine ER in retail and institutional channels?
4. Which patient populations are least likely to switch from PLENDIL to AB-rated felodipine ER generics?
5. How do dosage strength mix and titration patterns affect felodipine ER financial results post-genericization?

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References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-07-06).
2. FDA. Drugs@FDA Database. (Accessed 2026-07-06).