Last updated: June 9, 2026
Suppliers for INNOPRAN XL (propranolol HCl) and the Patent-Exposure Map for Generic Entry
INNOPRAN XL is an extended-release formulation of propranolol hydrochloride (HCl). The supplier landscape hinges on (1) who manufactures the proprietary drug product and (2) who supplies key components and contract manufacturing for extended-release (ER) tablets or associated intermediates. A complete, supplier-grade answer requires INNOPRAN XL’s specific FDA labeler/manufacturer details, the Orange Book reference-listed drug (RLD) mapping, and the current (and past) DMF/CMC authorizations tied to propranolol ER products.
No complete supplier dossier can be produced from the provided input alone.
What company manufactures INNOPRAN XL and who are the listed suppliers in the FDA label?
A correct supplier list requires the drug’s FDA label “Manufactured for” / “Distributed by” entities and the Orange Book applicant/RLD name for the propranolol ER reference. Those entities vary over time due to label revisions, repackaging, and contract manufacturing.
Where do INNOPRAN XL suppliers show up?
- Package insert labeler details (manufacturer/distributor)
- FDA Orange Book listing (applicant, dosage form, strength, RLD mapping)
- FDA drug master file (DMF) holders (excipients, tablet cores, coatings, ER matrices)
- Contract manufacturing organization (CMO) sites (site-specific in CMC disclosures)
Why “INNOPRAN XL” alone is not enough
“INNOPRAN XL” can correspond to different market authorizations by jurisdiction and label generation. Without the exact NDC(s) or the specific FDA submission/Orange Book entry, supplier identities cannot be tied to the correct product.
What patents protect INNOPRAN XL (propranolol ER) and how strong is the patent estate?
A patent exposure map requires identifying:
- The Orange Book patents tied to the propranolol ER RLD (composition, formulation, method-of-use, and device if applicable)
- Expiration dates by patent family and jurisdiction
- Exclusivity triggers (if any) tied to the RLD
Which patent types usually cover ER propranolol?
- Extended-release matrix technologies (release-rate control)
- Specific tablet core or coating compositions
- Method-of-use claims tied to dosing regimens or therapeutic indications (if separately patented)
- Manufacturing/process patents (granulation, pelletization, coating, compression)
What drives generic entry risk for propranolol ER?
- Whether the RLD has formulation or manufacturing patents still in force
- Whether listed patents are “active” for the specific strength and dosage form
- Whether the listed patents support Paragraph IV eligibility and settlement constraints
When does INNOPRAN XL lose exclusivity and when are patent expiration dates?
Exclusivity and patent timelines require:
- Orange Book expiration/notice-by-date fields
- Patent-by-patent expiration (and any pediatric exclusivity extensions)
- Any 30-month stay outcomes from Paragraph IV filings
What timeline components are typically audited?
- Patent expiration dates (composition and formulation)
- Regulatory exclusivity (if any) for the specific NDA/ANDA
- 180-day exclusivity for the first ANDA filer (generic competition dynamics)
What is the Orange Book status of INNOPRAN XL and which RLD does it map to?
Orange Book status is specific to the exact FDA product entry:
- RLD designation
- applicant name
- listed patents and exclusivity periods
- dosage form/strength granularity
Supplier implications of the Orange Book mapping
- If INNOPRAN XL maps to a specific RLD applicant, the supplier list can be anchored to that applicant’s CMC relationships
- If it maps to a repackager or labeler, the true manufacturing supplier must be identified via labeling and site details
Which generic companies are challenging INNOPRAN XL via ANDA Paragraph IV?
A complete challenge landscape requires:
- ANDA filings referencing the correct propranolol ER RLD
- Patent litigation records tied to those ANDAs
- Case numbers, settlement terms, and launch dates
What is typically tracked
- First Paragraph IV filer and 180-day exclusivity status
- Subsequent certifications and switching challenges across strengths
- Consent judgments or settlement agreements that govern launch timing
What formulations are protected for propranolol ER and what CMC barriers block suppliers?
ER tablets often have CMC-specific constraints:
- ER matrix composition and release profile
- Coating systems and dissolution targets
- Process controls that are difficult to replicate without formulation know-how
- Tablet size, hardness, and dissolution similarity requirements for ANDA bioequivalence
Common CMC risk points for ER generics
- Dissolution profile similarity across strengths
- In vitro release targeting for ER behavior
- Content uniformity and matrix integrity
How does INNOPRAN XL compare with other propranolol ER products for supplier overlap?
Supplier and manufacturing overlap are often driven by:
- Shared CMO facilities for ER tablet lines
- Common ER matrix or coating platforms used by multiple brand and generic applicants
- API/intermediate sourcing consistency for propranolol HCl
What benchmarking requires
- NDC-level identity mapping across brand and authorized generics
- Orange Book RLD and ANDA crosswalks
- CMO site and DMF link analysis
Key Takeaways
- INNOPRAN XL supplier identification cannot be completed from the single phrase “INNOPRAN XL.”
- A supplier-grade answer requires NDC-level product identity and Orange Book labeler mapping to anchor manufacturer, distributor, CMO sites, and DMF holders.
- Patent and exclusivity analysis also requires the exact Orange Book entry tied to the proprietary INNOPRAN XL listing.
FAQs
- How do I find the actual manufacturer of an ER tablet when the label lists a distributor?
- What Orange Book fields are most important for identifying proprietary patents on propranolol ER strengths?
- Do propranolol ER generic challenges typically hinge on formulation or method-of-use claims?
- How does 180-day ANDA exclusivity affect the number of suppliers for ER propranolol after launch?
- What CMC parameters most often delay ER tablet generic approval for propranolol hydrochloride?
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
- U.S. Food and Drug Administration. Drug Label Information and Prescribing Information for propranolol hydrochloride extended-release products. FDA.
