PRED-G Drug Patent Profile

When do Pred-g patents expire, and when can generic versions of Pred-g launch?

Pred-g is a drug marketed by Allergan and is included in two NDAs.

The generic ingredient in PRED-G is gentamicin sulfate; prednisolone acetate. There are fifteen drug master file entries for this compound. Additional details are available on the gentamicin sulfate; prednisolone acetate profile page.

Summary for PRED-G

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	60
Patent Applications:	2
Drug Prices:	Drug price information for PRED-G
What excipients (inactive ingredients) are in PRED-G?	PRED-G excipients list
DailyMed Link:	PRED-G at DailyMed

See drug prices for PRED-G

US Patents and Regulatory Information for PRED-G

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Allergan	PRED-G	gentamicin sulfate; prednisolone acetate	OINTMENT;OPHTHALMIC	050612-001	Dec 1, 1989		DISCN	Yes	No
Allergan	PRED-G	gentamicin sulfate; prednisolone acetate	SUSPENSION/DROPS;OPHTHALMIC	050586-001	Jun 10, 1988		DISCN	Yes	No

PRED-G Market Dynamics, Patent Status, FDA History, and Financial Trajectory

Last updated: July 31, 2026

PRED-G is a legacy ophthalmic combination containing prednisolone acetate 1% and gentamicin sulfate 0.3%. Its commercial position has been weakened by the age of both active ingredients, generic availability, limited differentiation from separate corticosteroid and antibiotic products, and the absence of publicly disclosed product-level revenue. PRED-G does not have the exclusivity profile of a modern branded ophthalmic drug. Its economic value is primarily tied to residual brand recognition, prescribing convenience, and distribution rather than patent protection.

What is PRED-G and what are its active ingredients?

PRED-G is an ophthalmic suspension combining:

Product attribute	PRED-G
Active corticosteroid	Prednisolone acetate
Corticosteroid strength	1%
Active antibiotic	Gentamicin sulfate
Antibiotic strength	0.3%
Dosage form	Ophthalmic suspension
Therapeutic category	Ophthalmic anti-inflammatory and antibacterial
Primary use	Steroid-responsive ocular inflammation where bacterial infection or risk of infection exists
Original sponsor	Allergan, Inc.
Regulatory pathway	New Drug Application
Current commercial profile	Legacy branded product with generic and therapeutic substitutes

Prednisolone acetate reduces ocular inflammation. Gentamicin is an aminoglycoside antibiotic active against susceptible bacteria. The combination is used when an ophthalmic steroid and antibacterial are clinically appropriate in the same treatment course. The FDA labeling states that corticosteroids should be prescribed cautiously because they can suppress local immune response, increase intraocular pressure, delay healing, and worsen certain viral or fungal eye infections (U.S. Food and Drug Administration [FDA], n.d.-a).

PRED-G is distinct from PRED FORTE, which contains prednisolone acetate without gentamicin. That distinction affects both market positioning and substitution patterns. Physicians can prescribe a steroid-only product, an antibiotic-only product, or separate products instead of a fixed-dose combination.

What is the FDA regulatory status of PRED-G?

PRED-G was approved as an ophthalmic combination product under an Allergan NDA. The FDA labeling identifies the product as prednisolone acetate ophthalmic suspension and gentamicin sulfate ophthalmic solution combined in a sterile ophthalmic formulation (FDA, n.d.-a).

The product’s regulatory economics are shaped by its age. Prednisolone acetate and gentamicin are long-established active ingredients, and the combination does not have the clinical or regulatory characteristics of a new molecular entity. Any remaining regulatory value would depend on the specific formulation, manufacturing controls, brand distribution, or an approved application rather than new-ingredient exclusivity.

Public FDA databases and labeling records do not establish a material period of current-market NCE exclusivity for PRED-G. The relevant commercial question is whether the branded product remains actively marketed and whether an approved generic or therapeutic substitute is available.

What dosage forms are associated with PRED-G?

PRED-G has been associated primarily with an ophthalmic suspension. Ophthalmic suspensions require control of particle size, uniformity, sterility, redispersibility, and dose delivery. Those requirements create manufacturing obligations, but they do not automatically create durable market exclusivity.

The presence of a suspension can give a product limited practical differentiation from solutions, ointments, and separately administered products. That differentiation is generally insufficient to support premium pricing when prescribers can use established alternatives.

What patents protect PRED-G?

PRED-G has no publicly visible patent profile comparable to a recently approved ophthalmic drug. The active ingredients are old, and any original composition or formulation patents would have expired long before the current market period.

Patent category	PRED-G relevance
Active-ingredient patent	Expired or unavailable as a source of current exclusivity
NCE exclusivity	Not applicable to these established active ingredients
Original combination patent	Any original term would be expired
Formulation patent	No material current exclusivity identified in public FDA-facing records
Method-of-use patent	No meaningful current barrier identified
Manufacturing patent	Potentially relevant to process know-how, but not a known market-blocking asset
Pediatric exclusivity	No material current exclusivity identified
Orphan-drug exclusivity	Not applicable

PRED-G’s commercial protection therefore does not depend on a live patent estate. The relevant intellectual-property risks are limited to formulation know-how, trademark rights, manufacturing specifications, and possible private contractual arrangements.

Does PRED-G have Orange Book-listed patents?

The Orange Book is the FDA’s principal public source for patents and regulatory exclusivity associated with approved drug products. A legacy ophthalmic combination such as PRED-G would require a current, approved listing and a valid patent term to create a meaningful Orange Book barrier to an ANDA applicant.

No material current Orange Book patent barrier is publicly associated with PRED-G in the product’s legacy market profile. The absence of a live listed patent means that a generic applicant would not face the same Paragraph IV litigation exposure seen with newer branded ophthalmic products (FDA, n.d.-b).

The absence of an Orange Book patent does not eliminate all regulatory or commercial risk. An applicant still must demonstrate pharmaceutical equivalence, bioequivalence where applicable, manufacturing quality, sterility, stability, and adequate labeling.

When does PRED-G lose exclusivity?

PRED-G’s meaningful exclusivity ended years ago through the combined effects of ingredient age, patent expiration, and generic or therapeutic substitution. There is no commercially significant future patent cliff comparable to a blockbuster small-molecule product with a remaining term.

Exclusivity mechanism	Current effect on PRED-G
Patent exclusivity	No material remaining protection identified
Five-year NCE exclusivity	Not applicable
Three-year new clinical investigation exclusivity	No current relevance identified
Orphan exclusivity	Not applicable
Pediatric exclusivity	No current relevance identified
Brand trademark	May protect the name, not the formulation
Distribution relationships	May support access, but are not statutory exclusivity

The principal loss of exclusivity occurred through ordinary lifecycle erosion rather than a single recent expiration date. For products of this age, the commercial decline usually precedes or accompanies a transition to generic supply.

Which companies challenge PRED-G?

No major public Paragraph IV litigation campaign is associated with PRED-G. That is consistent with the product’s limited remaining patent value and the low expected return from challenging an old ophthalmic combination.

Potential competitors include:

• Manufacturers of generic prednisolone acetate ophthalmic suspension.
• Manufacturers of generic gentamicin ophthalmic products.
• Suppliers of other steroid-antibiotic combinations.
• Manufacturers of separate corticosteroid and antibiotic eye drops.
• Branded products such as prednisolone acetate monotherapy and alternative anti-infective combinations.

For a generic manufacturer, the main barriers are technical and commercial rather than patent-based. Sterile ophthalmic manufacturing, suspension uniformity, container-closure integrity, preservative performance, and limited market size can reduce the attractiveness of entry.

What is the competitive landscape for PRED-G?

PRED-G competes in a mature ophthalmic anti-inflammatory and anti-infective segment. Its fixed-dose combination offers convenience, but the clinical need for simultaneous steroid and antibiotic therapy varies by diagnosis and physician preference.

Competitive option	Competitive advantage	Limitation relative to PRED-G
Generic prednisolone acetate	Low cost and broad availability	Does not provide antibacterial coverage
Generic gentamicin	Low cost and antibacterial activity	Does not provide steroid activity
Separate steroid plus antibiotic products	Dosing flexibility	More complex regimen and potentially higher cost
Steroid-antibiotic combinations	One-product convenience	May have different active ingredients or dosage characteristics
Branded steroid products	Brand familiarity and distribution	Higher price and limited differentiation
Fluoroquinolone-based combinations	Broad antibacterial positioning	Different safety, spectrum, and prescribing considerations

PRED-G’s market is also exposed to clinical substitution. Ophthalmologists may avoid fixed steroid-antibiotic combinations when infection is unconfirmed, when antibiotic coverage is unnecessary, or when a different antibacterial spectrum is preferred. The product can therefore lose share even without direct generic substitution.

What generic entry risks exist for PRED-G?

Generic entry risk is high because the core ingredients are established and the product has limited patent protection. The main risk is not a sudden patent-triggered launch but persistent price erosion and replacement by lower-cost alternatives.

How would a generic PRED-G launch affect the market?

A generic launch could produce four effects:

1. Lower reimbursement and pharmacy acquisition costs.
2. Reduced brand retention unless PRED-G has a strong formulary position.
3. Increased substitution by generic combination products.
4. Greater use of separate prednisolone and gentamicin prescriptions where combination pricing is unfavorable.

The commercial value of a generic combination depends on prescription volume, wholesaler access, reimbursement, and manufacturing cost. Ophthalmic products have relatively small unit volumes compared with oral generics, while sterile production adds quality-control expense. These factors can limit the number of economically viable suppliers.

What is the financial trajectory of PRED-G?

Public filings do not report standalone PRED-G revenue, gross margin, prescription volume, or operating profit. Allergan historically reported ophthalmic sales in broader therapeutic and product categories rather than disclosing financial results for every legacy ophthalmic SKU. After Allergan’s acquisition by AbbVie in 2020, PRED-G was not identified as a separately reported material product in AbbVie’s principal financial disclosures (AbbVie Inc., 2021).

The likely financial trajectory is:

Period	Market condition	Financial implication
Early commercialization	Branded fixed-dose ophthalmic combination	Premium pricing and physician familiarity
Generic maturation	Generic ingredients and substitutes become available	Price and volume pressure
Late lifecycle	Low differentiation and fragmented competition	Declining revenue contribution
Current legacy stage	Limited public commercial visibility	Likely immaterial to parent-company consolidated results

PRED-G is unlikely to be a material contributor to Allergan or AbbVie revenue. Large ophthalmology portfolios are driven by products with stronger differentiation, larger patient populations, newer mechanisms, premium delivery systems, or active lifecycle management. A legacy prednisolone-gentamicin combination does not fit those economic characteristics.

Is PRED-G revenue publicly disclosed?

No product-level revenue figure is publicly reported in the principal annual reports reviewed for Allergan and AbbVie. The absence of separate disclosure indicates that PRED-G was not material under the companies’ reporting thresholds or was included within broader ophthalmic categories (AbbVie Inc., 2021; Allergan plc, 2019).

This limits precise market-sizing. The more reliable conclusion is qualitative: PRED-G has a low and declining strategic value relative to modern branded ophthalmic products.

What licensing deals involve PRED-G?

No major publicly disclosed licensing or acquisition transaction has identified PRED-G as a separately valued asset. Its commercial history is associated with Allergan’s broader ophthalmology portfolio, and later corporate ownership passed through AbbVie’s acquisition of Allergan.

The lack of a disclosed standalone licensing transaction suggests that the product has not been treated as a strategic platform asset. Any private manufacturing, distribution, or commercialization arrangements would not establish a public valuation or extend statutory exclusivity.

What patent litigation affects PRED-G?

No material patent litigation involving PRED-G is publicly established as a current market issue. The product’s age and lack of a meaningful live patent estate reduce the incentive for branded-versus-generic litigation.

The litigation profile differs from newer ophthalmic products, where disputes may involve:

• Drug-device combination claims.
• Preservative-free multidose systems.
• Sustained-release delivery.
• Suspension particle-size specifications.
• Method-of-use claims.
• Orange Book-listed formulation patents.

PRED-G’s principal legal risks are more likely to involve product liability, manufacturing quality, labeling, trademark use, or supply obligations than patent infringement.

What manufacturing and intellectual-property barriers remain?

The remaining barriers are practical rather than exclusionary. A manufacturer must produce a sterile ophthalmic suspension that meets FDA standards for identity, strength, quality, purity, sterility, stability, and container performance.

Key technical requirements include:

• Consistent suspension redispersion.
• Uniform delivery of prednisolone acetate particles.
• Microbial control and validated sterilization.
• Preservative effectiveness where applicable.
• Container-closure integrity.
• Stability across the labeled storage period.
• Accurate ophthalmic drop delivery.

These requirements can discourage marginal entrants, but they do not support high pricing when several suppliers can manufacture comparable ophthalmic products.

How does PRED-G compare with PRED FORTE?

Attribute	PRED-G	PRED FORTE
Steroid	Prednisolone acetate 1%	Prednisolone acetate 1%
Antibiotic	Gentamicin sulfate 0.3%	None
Clinical positioning	Inflammation with bacterial coverage or risk	Steroid-responsive ocular inflammation
Substitution risk	Combination and component substitution	Generic prednisolone substitution
Pricing pressure	High	High
Patent value	Legacy, no material current barrier identified	Legacy product with generic competition
Prescribing flexibility	Lower than separate products	Higher when antibiotic is not needed

PRED-G may retain a convenience advantage when both ingredients are clinically appropriate. PRED FORTE has a broader steroid-only role but does not offer antibacterial coverage. Both products face generic prednisolone competition and limited current patent protection.

What is the likely generic launch scenario for PRED-G?

The most probable scenario is continued erosion through generic component products and therapeutic alternatives rather than a high-profile branded patent loss. A new generic fixed-dose combination could enter if the expected prescription volume supports sterile manufacturing and regulatory costs.

The commercial impact would depend on:

• Whether the branded product remains actively marketed.
• The number of approved generic suppliers.
• Pharmacy substitution rules.
• Payer reimbursement.
• Wholesale availability.
• Physician preference for fixed-dose treatment.
• Relative prices of combination and separate products.

A generic combination would likely gain share rapidly if the brand has no formulary advantage. If no generic combination is commercially viable, PRED-G can still lose demand to separate generic products.

What is the geographic coverage of PRED-G?

PRED-G’s strongest regulatory and commercial identity is in the United States. International availability varies by country because ophthalmic combinations may use different brand names, formulations, sponsors, or national approval pathways.

U.S. market exposure is governed by FDA approval, labeling, pharmacy distribution, and payer substitution. Foreign markets may have separate regulatory records and different patent, trademark, reimbursement, and generic-entry conditions. No global exclusivity position should be inferred from the U.S. product history.

Key Takeaways

• PRED-G combines prednisolone acetate 1% with gentamicin sulfate 0.3% in an ophthalmic suspension.
• Its active ingredients and combination are legacy technologies with no material current patent barrier identified.
• PRED-G has no significant remaining statutory exclusivity comparable to an NCE or protected specialty ophthalmic product.
• Public filings do not disclose standalone PRED-G revenue.
• Its likely financial trajectory is long-term decline, driven by generic substitution, therapeutic alternatives, and limited differentiation.
• No material current Paragraph IV campaign, patent litigation, or standalone licensing transaction is publicly associated with PRED-G.
• Remaining barriers are sterile ophthalmic manufacturing, formulation consistency, regulatory compliance, and distribution economics.
• Generic entry risk is high, but the market may be too small to attract numerous combination-product suppliers.
• PRED-G’s commercial value is likely immaterial to AbbVie’s consolidated financial results.

FAQs

Is PRED-G the same as prednisolone acetate?

No. Prednisolone acetate is the corticosteroid component of PRED-G. PRED-G also contains gentamicin sulfate, an antibiotic.

Can generic prednisolone acetate replace PRED-G?

Generic prednisolone acetate can replace the steroid component but does not provide gentamicin antibacterial coverage. A clinician may prescribe a separate antibiotic when both treatments are indicated.

Does PRED-G have a 30-month Paragraph IV stay?

No material current Paragraph IV litigation or 30-month stay involving PRED-G is publicly established. Its legacy patent profile does not indicate a current Orange Book barrier.

Is PRED-G a biologic or biosimilar product?

No. PRED-G is a conventional small-molecule ophthalmic drug. Biosimilar approval rules do not apply.

Why can a legacy ophthalmic product remain commercially available after patent expiration?

A legacy product can continue through brand loyalty, physician familiarity, established supply chains, limited generic competition, or demand for a fixed-dose combination. Those factors support residual sales but do not create statutory exclusivity.

References

AbbVie Inc. (2021). 2020 annual report. https://www.abbvie.com

Allergan plc. (2019). 2018 annual report. https://www.sec.gov

U.S. Food and Drug Administration. (n.d.-a). PRED-G: Prednisolone acetate and gentamicin sulfate ophthalmic suspension labeling. DailyMed. https://dailymed.nlm.nih.gov

U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book