ROBINUL Drug Patent Profile

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

Robinul is a drug marketed by Hikma, Robins Ah, and Casper Pharma Llc. and is included in three NDAs.

The generic ingredient in ROBINUL is glycopyrrolate. There is one drug master file entry for this compound. Sixty-one suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Robinul

A generic version of ROBINUL was approved as glycopyrrolate by AM REGENT on July 23^rd, 1986.

Summary for ROBINUL

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	6
Patent Applications:	5,053
Drug Prices:	Drug price information for ROBINUL
What excipients (inactive ingredients) are in ROBINUL?	ROBINUL excipients list
DailyMed Link:	ROBINUL at DailyMed

See drug prices for ROBINUL

Recent Clinical Trials for ROBINUL

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

Sponsor	Phase
McGill University Health Center	N/A
McGill University Health Centre/Research Institute of the McGill University Health Centre	N/A
University of Oulu	Phase 4

See all ROBINUL clinical trials

Pharmacology for ROBINUL

Drug Class	Anticholinergic Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Antagonists Cholinergic Muscarinic Antagonists

US Patents and Regulatory Information for ROBINUL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	ROBINUL	glycopyrrolate	INJECTABLE;INJECTION	017558-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	No
Casper Pharma Llc	ROBINUL FORTE	glycopyrrolate	TABLET;ORAL	012827-002	Approved Prior to Jan 1, 1982	AA	RX	Yes	No
Robins Ah	ROBINUL	glycopyrrolate	INJECTABLE;INJECTION	014764-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for ROBINUL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Casper Pharma Llc	ROBINUL	glycopyrrolate	TABLET;ORAL	012827-001	Approved Prior to Jan 1, 1982

ROBINUL Market Dynamics and Financial Trajectory: Glycopyrrolate Revenue, Competition, Patents, and Generic Risk

Last updated: September 24, 2026

ROBINUL is the legacy brand for glycopyrrolate, an anticholinergic drug used mainly to reduce secretions during anesthesia and to manage sialorrhea in selected clinical settings. Its commercial position is mature and largely genericized. The brand has limited publicly disclosed financial information, while most current market value is distributed across generic glycopyrrolate injection and oral products.

ROBINUL's principal commercial risks are generic substitution, low unit pricing, hospital purchasing concentration, and the absence of meaningful remaining brand exclusivity. Its most durable market position is in institutional injectable use, where supply reliability, regulatory compliance, and hospital formulary access matter more than consumer brand recognition.

What is ROBINUL and how is glycopyrrolate used?

ROBINUL contains glycopyrrolate, also known as glycopyrronium bromide in some non-U.S. markets. Glycopyrrolate is a quaternary ammonium anticholinergic that reduces muscarinic activity without readily crossing the blood-brain barrier.

The principal U.S. uses include:

Product form	Typical clinical use	Primary purchasing channel
Injectable glycopyrrolate	Preoperative reduction of salivary and respiratory secretions; reversal of neuromuscular blockade when used with an anticholinesterase	Hospitals, ambulatory surgery centers, anesthesia providers
Oral glycopyrrolate tablets	Reduction of excessive salivation and selected gastrointestinal anticholinergic uses	Retail pharmacies, specialty and institutional pharmacies
Compounded or alternative formulations	Sialorrhea and palliative-care applications	Compounding pharmacies, hospitals, specialty clinics

The U.S. prescribing information identifies ROBINUL injection as a prescription product used before or during anesthesia and in connection with reversal of neuromuscular blockade. Oral glycopyrrolate labeling covers reduction of secretions and related anticholinergic indications, although prescribing practices vary by market and indication.[1,2]

What is the FDA regulatory status of ROBINUL?

ROBINUL is an established, approved drug rather than a new molecular entity. Glycopyrrolate has been marketed for decades, and the original brand-based regulatory exclusivity period expired long ago.

FDA regulatory dynamics are divided between:

1. Legacy brand products associated with ROBINUL.
2. Abbreviated New Drug Application products for generic glycopyrrolate.
3. Manufacturer-specific injectable presentations.
4. Compounded formulations that do not have the same approval status as FDA-approved products.

The FDA’s Drugs@FDA and Orange Book records provide the principal sources for approved products, reference-listed drugs, and patent or exclusivity information.[3,4] Current U.S. market competition is primarily based on ANDA approval, manufacturing capacity, contract supply, price, and hospital contracting.

FDA status by product category

Category	Regulatory position
Original ROBINUL brand	Legacy approved product with no meaningful remaining new-drug exclusivity
Generic glycopyrrolate injection	Approved through ANDAs and marketed by multiple manufacturers over time
Generic oral glycopyrrolate	Approved oral alternatives compete with the historical ROBINUL tablet product
Compounded glycopyrrolate	Subject to compounding rules and not equivalent to an FDA-approved commercial product
Biosimilar exposure	None; glycopyrrolate is a small-molecule drug, not a biologic

When does ROBINUL lose exclusivity?

ROBINUL lost practical market exclusivity decades ago. The product is not protected by a current data-exclusivity period comparable to a recently approved drug, and glycopyrrolate has long been exposed to generic competition.

The principal commercial conclusion is that ROBINUL is a post-exclusivity product. Any remaining brand sales depend on prescribing preference, supply availability, institutional contracting, or distributor relationships rather than patent-based exclusivity.

Exclusivity timeline

Period	Market event	Commercial effect
Early development and original approval	Glycopyrrolate introduced as an anticholinergic product	Established the ROBINUL brand
Subsequent decades	Oral and injectable formulations became established in clinical practice	Created a durable clinical franchise
Generic-entry period	ANDA products entered the U.S. market	Reduced brand pricing power
Current market	Multiple generic and supplier-specific products compete	Brand value is concentrated in supply reliability and recognition

No active biosimilar pathway applies to ROBINUL. The relevant competitive mechanism is generic substitution under the Hatch-Waxman framework.

What patents protect ROBINUL?

Publicly available FDA records do not indicate a commercially meaningful active patent estate protecting the original ROBINUL glycopyrrolate products. The key product, active ingredient, and traditional dosage forms are mature.

Patent protection should be evaluated separately for:

• The glycopyrrolate active ingredient.
• Injectable formulations.
• Oral tablet formulations.
• Combination products.
• Delivery systems.
• New methods of treating sialorrhea or related conditions.
• Manufacturing processes and impurity-control methods.

For the historical ROBINUL products, formulation and method-of-use patents do not appear to create a current barrier comparable to the patent estates surrounding newer branded drugs. Any later-filed patent relating to a specific formulation or use would need to be assessed for claim scope, enforceability, terminal disclaimers, expiration, and Orange Book listing status.

Patent-estate assessment

Patent category	Current relevance to ROBINUL
Composition-of-matter patent	Expired or commercially irrelevant because glycopyrrolate is an old active ingredient
Original formulation patent	No identified current barrier to generic competition
Injectable formulation patent	Limited relevance unless tied to a specific approved presentation
Method-of-use patent	Potentially relevant only for a narrow patented indication
Manufacturing patent	Could affect process economics but generally does not block ordinary generic entry
Orange Book-listed patent	No material active patent barrier identified for the legacy product

The FDA Orange Book should be checked for product-specific listings because a patent can apply to one presentation without protecting all glycopyrrolate products.[4]

How many patents cover ROBINUL?

ROBINUL does not appear to have a commercially significant active Orange Book patent portfolio. The product’s market status is therefore determined primarily by generic approval and manufacturing competition, not by a multi-patent lifecycle-management strategy.

Historical patent documents may still exist in public records. Their existence does not establish current enforceability or commercial relevance. For valuation, the important distinction is between:

• Expired historical patents.
• Unlisted process patents.
• Narrow patents covering a particular formulation or indication.
• Active Orange Book-listed patents capable of supporting a Paragraph IV litigation strategy.

On that basis, ROBINUL should be classified as a low-patent-barrier pharmaceutical product.

Are there Paragraph IV challenges to ROBINUL?

Paragraph IV litigation risk is low for the original ROBINUL brand because generic competition has already been established for glycopyrrolate. Paragraph IV certifications are most commercially important when an ANDA applicant challenges an unexpired Orange Book-listed patent before generic launch.

For a mature product such as ROBINUL:

• The principal generic-entry events occurred after the original exclusivity period.
• Current generic suppliers generally compete within an established market.
• New Paragraph IV activity would be relevant only if a new patent were listed against a particular formulation, use, or dosage form.
• A generic applicant would more likely rely on ordinary ANDA substitution than on a high-value patent challenge.

No major current Paragraph IV dispute is broadly associated with the legacy ROBINUL franchise in the public record reviewed for this analysis.

What patent litigation affects ROBINUL?

No major active patent litigation appears to define the current commercial outlook for ROBINUL. Litigation risk is more likely to arise from:

1. Manufacturing disputes between generic suppliers.
2. Product liability claims.
3. Distribution or supply-contract disputes.
4. Patent claims involving a modified glycopyrrolate formulation.
5. Compounded-product enforcement or regulatory actions.

This differs from branded medicines with large sales exposed to an imminent loss of exclusivity. ROBINUL has already passed that stage.

What is the Orange Book status of ROBINUL?

The Orange Book remains relevant for identifying the reference-listed drug and determining whether a listed patent or exclusivity period could affect an ANDA. For ROBINUL, the Orange Book’s commercial significance is limited because the product is mature and generic alternatives are established.

The Orange Book analysis should distinguish between:

• ROBINUL as a reference product.
• Specific strengths and dosage forms.
• Oral versus injectable products.
• Discontinued products that remain listed for historical regulatory purposes.
• Active marketed presentations versus products that have been discontinued for commercial reasons.

A discontinued brand listing does not necessarily mean the drug was withdrawn for safety or efficacy reasons. FDA records should be read together with the product label and discontinuation status.[3,4]

How strong is the ROBINUL patent estate?

The ROBINUL patent estate is weak from a brand-defense perspective and largely irrelevant to current generic competition.

Factor	Assessment
Active composition-of-matter protection	None of practical importance
Remaining regulatory exclusivity	None of practical importance
Formulation differentiation	Limited
Method-of-use protection	Narrow and not central to the legacy brand
Manufacturing barriers	Moderate at the plant and quality-system level, low at the patent level
Generic substitution risk	High
Litigation leverage	Low
Brand pricing power	Low

The strongest defensible asset is not a patent claim. It is operational execution in injectable manufacturing, quality control, sterile fill-finish, inventory management, and hospital contracting.

What is the competitive landscape for glycopyrrolate?

The market includes generic manufacturers, hospital suppliers, contract manufacturers, and compounding pharmacies. Competition differs by dosage form.

Injectable glycopyrrolate

Injectable glycopyrrolate is the more strategically important segment because hospitals and surgery centers require dependable sterile supply. Manufacturers compete on:

• Unit price.
• National distribution.
• Contracting with group purchasing organizations.
• Shortage performance.
• Vial and ampule configurations.
• Regulatory inspection history.
• Ability to maintain production during supply disruptions.

Brand recognition has less influence in this segment than formulary status and product availability.

Oral glycopyrrolate

Oral tablets face more direct generic substitution. The product is prescribed in a range of settings, including sialorrhea management and selected off-label uses. Pricing is generally lower, and the market is more exposed to pharmacy benefit-manager substitution and reimbursement pressure.

Compounded products

Compounded oral liquids and other formulations can compete in pediatric, palliative-care, and specialty-use settings. These products may address dosage or administration needs not served by standard tablets. They do not have the same FDA approval status as commercially approved glycopyrrolate products, and their market access depends on state and federal compounding requirements.[5]

What are the financial results and revenue trajectory for ROBINUL?

Standalone ROBINUL revenue is not generally disclosed in public company filings. Companies that manufacture or distribute glycopyrrolate typically report broader portfolios, such as injectable medicines, hospital products, or generic pharmaceuticals. As a result, a precise ROBINUL revenue series cannot be derived from SEC filings alone.

The financial trajectory is best characterized as follows:

Stage	Revenue profile	Margin profile
Brand-growth period	Brand-driven prescribing and limited competition	Higher branded margins
Generic-entry period	Rapid erosion in brand volume and price	Margin compression
Mature generic period	Stable but fragmented demand	Low to moderate product margins
Current market	Volume tied to hospital procedures and supply availability	Returns depend on manufacturing efficiency and contracts

The brand’s direct revenue exposure is likely modest relative to the total glycopyrrolate market. The larger economic opportunity lies in supplying generic injectable products at scale.

Key financial drivers

• Hospital procedure volumes.
• Anesthesia and surgery-center activity.
• Generic price competition.
• Sterile manufacturing capacity.
• Product shortages.
• Contract wins with hospitals and group purchasing organizations.
• Reimbursement for oral products.
• Competition from alternative anticholinergic agents.
• Regulatory compliance costs.
• Distributor and wholesaler inventory levels.

Publicly reported sales for a specific ROBINUL brand presentation should not be confused with total glycopyrrolate market revenue. The latter includes generic products and may be several times larger than brand sales, depending on the geography and dosage form.

What licensing deals affect ROBINUL?

No major, publicly disclosed licensing transaction appears to define the present ROBINUL market. Historical rights may have changed through corporate acquisitions, divestitures, or distribution agreements, but the product’s mature status reduces the strategic value of standalone brand licensing.

Potential commercial arrangements are more likely to involve:

• Contract manufacturing.
• Authorized generic distribution.
• Hospital supply agreements.
• Generic portfolio acquisitions.
• Regional marketing rights.
• Private-label injectable supply.

For valuation purposes, a distribution agreement should be distinguished from a patent license. A distributor may sell an approved product without owning intellectual property or controlling manufacturing technology.

What manufacturing and intellectual-property barriers affect glycopyrrolate?

The major barrier is sterile manufacturing rather than drug-discovery intellectual property. Injectable glycopyrrolate requires validated aseptic processing, quality systems, container-closure integrity, stability data, and reliable supply-chain controls.

Manufacturing risks include:

• Sterile-facility capacity constraints.
• Inspection findings.
• Raw-material shortages.
• Packaging-component shortages.
• Batch failures.
• Long lead times for hospital contracts.
• Concentrated supplier bases.
• Low margins that reduce incentives for redundant capacity.

These factors can create temporary pricing power for suppliers even when no patent protection exists. FDA drug-shortage records and manufacturer communications are important indicators of supply risk.[6]

What generic launch scenarios exist for ROBINUL?

Three generic-market scenarios are commercially credible.

Base case: continued commoditization

Generic manufacturers maintain supply, and prices remain under pressure. The ROBINUL brand retains limited use where physicians or hospitals specify it, but substitution remains high.

Supply-constrained case: temporary price recovery

A manufacturing interruption or shortage removes one or more generic suppliers. Remaining manufacturers gain short-term volume and pricing leverage. This effect is usually temporary because additional suppliers can enter or restore production.

Differentiated-formulation case: niche growth

A manufacturer obtains approval for a differentiated dosage form, concentration, device, or formulation. The product can command better economics if it solves a genuine administration or workflow problem. This strategy would create a new product opportunity, not restore broad exclusivity to legacy ROBINUL.

How does ROBINUL compare with competing anticholinergic drugs?

Drug	Main role	Competitive position versus glycopyrrolate
Atropine	Bradycardia, secretion reduction, emergency medicine	Broader emergency use but more central nervous system penetration
Scopolamine	Motion sickness and secretion reduction	Strong transdermal niche; different adverse-effect and use profile
Neostigmine plus anticholinergic therapy	Reversal of neuromuscular blockade	Glycopyrrolate may be selected to manage muscarinic effects
Ipratropium and related inhaled agents	Bronchodilation	Different route and therapeutic market
Botulinum toxin products	Chronic sialorrhea in selected patients	Higher-cost alternative for specific patients and indications
Compounded anticholinergic liquids	Pediatric and specialty administration	Flexible dosing but different regulatory status

Glycopyrrolate’s commercial advantage is its established use, relatively predictable pharmacology, and availability in injectable and oral forms. Its disadvantage is limited differentiation and intense generic pricing pressure.

What is the investment and commercial outlook for ROBINUL?

ROBINUL is not an attractive classic brand-exclusivity asset. It is better analyzed as a mature pharmaceutical supply business.

The most relevant investment questions are:

1. Does the manufacturer control reliable sterile capacity?
2. Is the product included in hospital and group-purchasing contracts?
3. Can the supplier sustain margins after generic price reductions?
4. Is there a shortage-related opportunity?
5. Does the product have a differentiated formulation or delivery system?
6. Are regulatory or manufacturing issues likely to interrupt supply?
7. Is revenue reported within a larger generic portfolio?

A company with a broad injectable portfolio may benefit from glycopyrrolate as part of a hospital-products platform. A company seeking high-margin intellectual property would find limited value in the legacy ROBINUL brand alone.

Key Takeaways

• ROBINUL is the legacy brand associated with glycopyrrolate.
• The product is mature and has no meaningful remaining original-drug exclusivity.
• Generic competition is the primary market force.
• No commercially significant active patent estate or major current patent litigation is associated with the legacy franchise.
• There is no biosimilar risk because glycopyrrolate is a small-molecule drug.
• Injectable glycopyrrolate is more strategically important than oral tablets because hospital supply and sterile manufacturing influence market access.
• Standalone ROBINUL revenue is not generally disclosed by manufacturers.
• The financial trajectory is consistent with brand-to-generic erosion followed by lower-margin, supply-driven mature-market economics.
• The principal barriers are sterile manufacturing, quality compliance, distribution, and contracting, not composition-of-matter patents.
• Future value would depend on differentiated formulations, shortage-driven supply advantages, or integration into a broader injectable portfolio.

Frequently Asked Questions

Is ROBINUL still sold in the United States?

Glycopyrrolate products remain available in the United States, primarily through generic oral and injectable products. Availability of the specific ROBINUL brand presentation can vary by manufacturer, distributor, and product status.

Is glycopyrrolate the same drug as ROBINUL?

Yes. ROBINUL is a brand associated with glycopyrrolate. Generic glycopyrrolate products contain the same active ingredient, subject to the applicable FDA approval and product specifications.

Can a generic company launch glycopyrrolate without a patent license?

Yes, if the product is eligible for ANDA approval and no enforceable patent or regulatory exclusivity blocks approval or commercial launch. The legacy glycopyrrolate market is broadly genericized.

Does ROBINUL have pediatric exclusivity?

No current pediatric exclusivity period is known to provide a material commercial barrier for the legacy ROBINUL franchise.

Is injectable glycopyrrolate vulnerable to drug shortages?

Yes. Injectable products can be exposed to shortages caused by sterile-facility interruptions, manufacturing deviations, raw-material constraints, or supplier concentration. The risk is operational rather than primarily patent-driven.

References

1. U.S. Food and Drug Administration. (n.d.). ROBINUL (glycopyrrolate) injection prescribing information. Drugs@FDA.

2. U.S. Food and Drug Administration. (n.d.). Glycopyrrolate tablets prescribing information. Drugs@FDA.

3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs database. https://www.accessdata.fda.gov/scripts/cder/daf/

4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/

5. U.S. Food and Drug Administration. (n.d.). Compounding and the FDA: Questions and answers. https://www.fda.gov/drugs/human-drug-compounding

6. U.S. Food and Drug Administration. (n.d.). Drug shortages database. https://www.accessdata.fda.gov/scripts/drugshortages/