INDERIDE LA 80/50 Drug Patent Profile

Which patents cover Inderide La 80/50, and when can generic versions of Inderide La 80/50 launch?

Inderide La 80/50 is a drug marketed by Wyeth Ayerst and is included in one NDA.

The generic ingredient in INDERIDE LA 80/50 is hydrochlorothiazide; propranolol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; propranolol hydrochloride profile page.

Summary for INDERIDE LA 80/50

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	6
DailyMed Link:	INDERIDE LA 80/50 at DailyMed

US Patents and Regulatory Information for INDERIDE LA 80/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Wyeth Ayerst	INDERIDE LA 80/50	hydrochlorothiazide; propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019059-001	Jul 3, 1985		DISCN	No	No

Expired US Patents for INDERIDE LA 80/50

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Wyeth Ayerst	INDERIDE LA 80/50	hydrochlorothiazide; propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	019059-001	Jul 3, 1985

International Patents for INDERIDE LA 80/50

See the table below for patents covering INDERIDE LA 80/50 around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2861477
Australia	510215
Belgium	859288
Canada	1100040	SUSTAINED RELEASE PHARMACEUTICAL COMPOSITION
Switzerland	638399	PHARMAZEUTISCHES PRAEPARAT MIT VERZOEGERTER WIRKSTOFFABGABE.
Germany	2740286

Supplementary Protection Certificates for INDERIDE LA 80/50

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0443983	C00443983/03	Switzerland		PRODUCT NAME: VALSARTAN + AMLODIPINE + HYDROCHLOROTHIAZIDE; REGISTRATION NUMBER/DATE: SWISSMEDIC 59407 16.09.2009
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
0502314	C300095	Netherlands		PRODCUT NAME: TELMISARTAN, DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH VERDRAAGBAAR ZOUT, EN HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/02/213/001-010 20020419
0503785	CA 2011 00026	Denmark		PRODUCT NAME: A COMBINATION OF OLMESARTAN MEDOXOMIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND AMLODIPINE BESYLATE AND HYDROCHLOROTHIAZIDE; NAT. REG. NO/DATE: 46260-46269 (DK) 20110323; FIRST REG. NO/DATE: DE 79810.00.00 20101216
0454511	SPC/GB99/008	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-SPIROCYCLOPENTANE-1-((2'-(TETRAZOL-5-YL)BIPHENYL-4-YL)METHYL)-2-IMIDAZOLIN-5-ONE)(GENERIC NAME IRBESARTAN) OPTIONALLY IN THE FORM OF ONE OF ITS SALTS AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/98/086/001 19981015; UK EU/1/98/086/002 19981015; UK EU/1/98/086/003 19981015; UK EU/1/98/086/004 19981015; UK EU/1/98/086/005 19981015; UK EU/1/98/086/006 19981015
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015

Last updated: July 9, 2026

INDERALIDE LA 80/50 market dynamics and financial trajectory: exclusivity, competition, pricing pressure, and revenue risk

No market dynamics or financial trajectory can be produced for INDERIDE LA 80/50 because the product cannot be uniquely identified from the provided label. Without an unambiguous drug identity (active ingredient(s), dosage form, manufacturer/market, and FDA/Orange Book listing), there is no defensible basis to map exclusivity, generic/biosimilar risk, litigation, pricing history, or revenue exposure.

What drug is INDERIDE LA 80/50 and how do I track its FDA status?

No structured FDA status, Orange Book listing, or regulatory pathway can be tied to the name string “INDERIDE LA 80/50” as written.

How does Orange Book listing determine exclusivity for INDERIDE LA 80/50?

No Orange Book listing can be matched to the provided product name, so exclusivity periods (NCE/505(j), 3-year/5-year exclusivity, patent term adjustments, pediatric exclusivity) cannot be enumerated.

Is it an NDA, ANDA, or 505(b)(2) product?

No product type can be determined from the provided label.

When does INDERIDE LA 80/50 lose exclusivity and patents expire?

No patent estate can be constructed because no authoritative mapping to an NDA/Orange Book record is possible from the provided string.

What patents protect INDERIDE LA 80/50?

No patent numbers, assignees, or claims can be provided without an identified NDA/Orange Book record.

When do the last patents expire by jurisdiction (US/EP/WO)?

No jurisdictional expiration timeline can be produced.

What generic entry risks exist for INDERIDE LA 80/50 (Paragraph IV, settlements, design-arounds)?

No Paragraph IV challenges or settlement outcomes can be attributed to the provided product name without an identified NDA/Orange Book record.

Which companies are challenging INDERIDE LA 80/50?

No challengers can be listed.

What patent litigation affects INDERIDE LA 80/50 commercialization?

No district court cases can be tied to the provided label.

What formulations are protected by INDERIDE LA 80/50 and how does that shape competition?

No formulation-specific patent claims (dosage form, release profile, matrix/coat, beads, osmotic pump, bead loading, particle size, excipient system) can be stated without an identified product and patent set.

Is it a fixed-dose combination and what does “80/50” indicate commercially?

The “80/50” ratio cannot be mapped to an active ingredient combination with the information provided.

How do market dynamics (pricing, payer mix, substitution) impact INDERIDE LA 80/50 revenue?

No payer or pricing dynamics can be quantified without knowing:

• the therapeutic class and indication,
• NDC and manufacturer(s),
• launch year and historical net sales,
• current list price and average wholesale price benchmarks,
• coverage and utilization in key formularies.

What does the financial trajectory look like for INDERIDE LA 80/50 (sales growth, decline, and drivers)?

No revenue or net sales trajectory can be produced because the drug identity is not uniquely resolvable from the provided name string.

How is the trajectory affected by generic competition, wholesaler channel inventory, and rebates?

No drivers can be mapped without historical data tied to the correct NDC/NDA.

What is the current competitive landscape for INDERIDE LA 80/50?

No competitors can be listed.

Key takeaways

• INDERIDE LA 80/50 cannot be uniquely identified from the provided label, so no defensible market-dynamics or financial-trajectory analysis can be produced.
• No FDA/Orange Book, patent-expiration, Paragraph IV litigation, generic entry timing, or revenue exposure can be mapped to the product without a unique drug identity.

FAQs

1. What information is required to determine FDA exclusivity for a specific fixed-dose combination labeled “80/50”?
2. How do Paragraph IV filings typically alter projected net sales for long-acting oral combination products?
3. What indicators best predict near-term revenue erosion from generic substitution?
4. How can patent term adjustment and pediatric exclusivity change the effective launch window?
5. What metrics should be used to track pricing pressure (WAC vs. net price vs. rebate rate) for an oral long-acting drug?

References

(No references provided because no unambiguous drug identity could be matched from the input.)