BICILLIN C-R 900/300 Drug Patent Profile

Which patents cover Bicillin C-r 900/300, and when can generic versions of Bicillin C-r 900/300 launch?

Bicillin C-r 900/300 is a drug marketed by King Pharms Llc and is included in one NDA.

The generic ingredient in BICILLIN C-R 900/300 is penicillin g benzathine; penicillin g procaine. There are ninety-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the penicillin g benzathine; penicillin g procaine profile page.

Summary for BICILLIN C-R 900/300

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for BICILLIN C-R 900/300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
King Pharms Llc	BICILLIN C-R 900/300	penicillin g benzathine; penicillin g procaine	INJECTABLE;INJECTION	050138-003	Approved Prior to Jan 1, 1982		RX	Yes	Yes

Last updated: July 15, 2026

Bicillin C-R 900/300 Investment Scenario and Patent/Fundamentals Analysis (Supply, Exclusivity, and Generic/Biosimilar Risk)

Bicillin C-R 900/300 is a compounded-brand combination of benzathine penicillin G and procaine penicillin G in a fixed “C-R 900/300” dose ratio, marketed for intramuscular treatment of susceptible bacterial infections. The investment case is typically not driven by IP-led innovation but by (1) supply-chain continuity of the penicillin G intermediates and sterile injectable manufacturing, (2) reimbursement and procurement volumes through institutional buyers, and (3) low-to-moderate risk of FDA generic entry given its older active substances and the likelihood of multiple authorized generic/ANDA and compounding pathways.

From a patent estate and regulatory-control standpoint, the core commercial risk is earlier and broad exhaustion of meaningful composition-of-matter and use protections for benzathine/procaine penicillin products, with incremental protection (if any) usually limited to specific formulations, packaging, or manufacturing processes. The investment upside is therefore more exposed to contracting dynamics and manufacturing reliability than to brand defensibility.

What is Bicillin C-R 900/300 and what are the drug fundamentals behind demand?

Bicillin C-R 900/300 is an IM penicillin product. The “900/300” labeling reflects the combined total units of benzathine penicillin G and procaine penicillin G intended for a dual-release exposure profile (longer-acting benzathine plus faster-acting procaine).

Clinical use profile (high level)

• Indicated for bacterial infections where penicillin G is appropriate.
• Institutional use patterns: acute-care and outpatient settings for susceptible infections where penicillin IM is preferred for dosing practicality and adherence.

Demand drivers

• Procurement and formulary inclusion for generic penetration-robust hospital channels.
• Substitution behavior: clinicians and hospitals tend to switch within the penicillin G IM class based on availability, price, and procurement terms.
• Short supply shocks often translate to temporary price/volume swings rather than sustained premium margins.

Cost of goods and manufacturing sensitivity

• The product is a sterile injectable. Execution risk is tied to:
  • sterile fill-finish capacity
  • control of particle dispersion for IM suspensions
  • stable sourcing of penicillin G salts/intermediates
  • batch-to-batch potency consistency

Investor implication

• Fundamentals correlate more with manufacturing uptime, procurement leverage, and penicillin supply conditions than with blockbuster IP tailwinds.

What patents protect Bicillin C-R 900/300 (benzathine/procaine penicillin IM) in the US?

A complete, accurate “which patents protect this specific product” map requires the exact FDA reference listing or Orange Book record tied to Bicillin C-R 900/300. Without that linkage, the patent landscape cannot be enumerated with the precision needed for investment, licensing, or litigation decisions.

What can be stated from category-level realities (not product-specific listings)

• Benzathine penicillin G and procaine penicillin G are established older active ingredients. Composition-of-matter protection for these actives is long expired in most jurisdictions.
• Protection, where it exists, is usually narrow and could relate to:
  • specific fixed-dose ratios (if claimed)
  • formulation and suspension characteristics
  • manufacturing methods
  • packaging and device interactions (less common for classic IM suspensions)
  • regulatory exclusivity attached to a specific NDA/BLA, typically long lapsed for historical penicillin products

Investor implication

• Treat this as an “IP-limited brand” or “long-generic” asset class unless Orange Book shows living, product-specific patents tied to a currently marketed NDA.

When does Bicillin C-R 900/300 lose exclusivity, and how should that shape timing?

Given the age of benzathine/procaine penicillin products, meaningful exclusivity windows (composition or NDA exclusivity) are generally already past for modern brand iterations, but this must be confirmed through the Orange Book for the exact product’s NDA.

Timing framework that matters for investors

• If the product is marketed under an NDA with any still-listed patents:
  • the next milestone is patent expiration, then any permitted generic or label carve-out entry.
• If exclusivity is not present or patents are expired:
  • pricing pressure can be expected immediately upon supply recovery and new authorized supply.

Investor implication

• In practice for older penicillin IM products, the “timing” variable is supply and contracting rather than a countdown to legal entry.

What is the Orange Book status of Bicillin C-R 900/300?

A precise Orange Book status cannot be produced without the specific FDA listing (NDA number, applicant, and Orange Book record). The Orange Book determines:

• which patents are listed
• whether they are associated with the product
• the listed expiration dates and patent types (composition, method, formulation)
• whether any patents remain enforceable

Investor implication

• The Orange Book record is the single source of truth for exclusivity-based underwriting. Without it, exclusivity-based valuation is not investable.

How many patents cover Bicillin C-R 900/300 formulations, methods, or uses?

Product-specific patent counts must come from the Orange Book record for the exact Bicillin C-R 900/300 listing and patent family set. Without it, any numeric count would be fabricated.

Investment implication

• Underwrite “patent count” using Orange Book. If the estate is zero or near-zero:
  • assume generic and authorized supply participation sooner than equity markets expect
  • focus on distribution advantage and supply reliability instead of defensibility

What Paragraph IV challenges or generic entry risks exist for Bicillin C-R 900/300?

Paragraph IV is an ANDA challenge mechanism to listed patents for an NDA product. For classic older penicillin injectables, generic entry risk is commonly high because:

• active ingredients are mature
• formulations and dosing ratios are often widely developed and replicated
• multiple competitors can supply authorized generics without relying on complex novel chemistry

But for this specific product

• Whether a Para IV campaign exists depends on the Orange Book listing and the timing of any still-listed patents.
• Whether any generic entry is already established depends on current ANDA approvals and authorized supply status.

Investor implication

• Without the listing, the correct stance for underwriting is: assume structural pressure once patents are gone; then validate with current authorized generic presence and current NDC competition intensity.

What litigation affects Bicillin C-R 900/300 patents or generic approvals?

Patent litigation risk requires:

• identification of the NDA and listed patents
• any district court cases alleging infringement for those patents
• any ITC actions or settlement terms that include launch-agreements

Without the product’s patent identifiers and case docket links, an accurate litigation map cannot be produced.

Investor implication

• For older penicillin IM products, litigation is often less central than supply and contracting, but the correct view is obtained only from product-level dockets.

How does Bicillin C-R 900/300 compare with other benzathine/procaine penicillin IM products (risk and value)?

Commercial comparison for this class typically hinges on:

• dose units and labeling
• suspension performance and administration reliability
• supplier quality systems (sterility assurance)
• availability through GPO and state contracts
• total cost per course of therapy

Investment implication

• For this category, competitive advantage usually comes from procurement terms and manufacturing scale, not from patient outcomes differentiation.

What FDA regulatory pathway governs Bicillin C-R 900/300 and its generic equivalents?

This product is an IM antibiotic drug product with longstanding regulatory history. Generics for such products are typically approved via ANDA referencing an NDA, and labeling updates occur through standard regulatory mechanisms.

Investor implication

• The pace of generic replacement is driven by:
  • ANDA filing density
  • ability to secure sterile injectable manufacturing capacity
  • product-specific bioequivalence considerations (for suspensions, comparative performance data and quality controls matter)

What manufacturing and IP barriers could block generic competition for Bicillin C-R 900/300?

For older sterile injectables, barriers are usually operational rather than scientific:

• aseptic processing and sterility assurance
• stable suspension formulation and reproducibility
• potency and particle size distribution control
• supply chain quality for penicillin intermediates
• regulatory inspection outcomes that can delay launches

Investor implication

• Even with weak IP, a supplier with proven sterile injection execution can sustain share during disruptions, creating short-lived pricing power.

Commercial scenario: what revenue exposure and margin profile should investors model?

Because the product fundamentals are procurement-driven, the investment model should reflect:

• volume cyclicality with institutional purchasing cycles
• gross margin sensitivity to sterile fill-finish costs and penicillin input costs
• rebate and contract intensity for hospital and government channels
• interruption risk from manufacturing or supplier outages

Base-case scenario logic (category-consistent)

• Expect normal pressure from authorized generics once supply stabilizes.
• Premium margins tend to be temporary and tied to shortage conditions rather than enduring brand positioning.

Bear-case

• increased competition in contract channels
• manufacturing disruptions or quality events
• price resets through GPO rebids

Bull-case

• supply reliability plus favorable contract renewals
• input cost stabilization
• reduced competitors due to capacity or quality issues

Key investment thesis: is Bicillin C-R 900/300 an IP-led or operations-led bet?

For this drug class, the economically relevant drivers are typically operations-led:

• sterile injectable execution
• procurement relationships
• supply-chain continuity
• regulatory compliance track record

IP-led underwriting requires living, product-specific Orange Book patents and verified patent validity/enforceability posture. Without that, the correct investment posture is operations and market structure.

Key Takeaways

• Bicillin C-R 900/300 is a benzathine/procaine penicillin G IM antibiotic product; value is driven primarily by supply reliability and institutional contracting, not innovation-led exclusivity.
• Composition-of-matter protections for benzathine/procaine penicillin active substances are generally long expired; any meaningful product-specific patents must be verified through the exact Orange Book listing.
• Generic and authorized supply pressure is typically structurally high for mature antibiotic IM suspensions once meaningful patents and exclusivity lapse.
• The investable fundamentals focus on manufacturing uptime, sterile injectable capability, input cost volatility, and procurement-driven pricing dynamics.
• Patent and litigation diligence must be anchored to the specific NDA and Orange Book record for Bicillin C-R 900/300; without it, legal defensibility cannot be quantified.

FAQs

1) What makes benzathine/procaine penicillin IM pricing differ from other antibiotics?
Institutional procurement, contract rebids, and sterile injectable supply continuity often dominate; clinical differentiation is usually secondary.

2) Do sterile injectable manufacturing risks matter more than patent risk for Bicillin C-R 900/300?
For mature penicillin IM suspensions, execution and supply reliability typically drive outcomes more than remaining patent life.

3) Are compounding and pharmacy substitution credible competitive threats to Bicillin C-R 900/300?
They can be relevant in certain channel conditions, but market impact depends on contracting and availability of approved generics/authorized supply.

4) What indicators should track for near-term profitability in this category?
Hospital contract renewals, GPO pricing movements, penicillin input pricing, and fill-finish capacity/sterility inspection status.

5) How should investors stress test downside for this product?
Model margin compression from authorized generic entry, contract price resets, and any sterile injectable supply interruptions or quality-driven volume loss.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Orange Book database). https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. ANDA (Abbreviated New Drug Application) overview and relevant FDA guidance materials. https://www.fda.gov/drugs/abbreviated-new-drug-application-anda