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Last Updated: April 2, 2025

GLYRX-PF Drug Patent Profile


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When do Glyrx-pf patents expire, and when can generic versions of Glyrx-pf launch?

Glyrx-pf is a drug marketed by Exela Pharma and is included in one NDA.

The generic ingredient in GLYRX-PF is glycopyrrolate. There are seventeen drug master file entries for this compound. Fifty-eight suppliers are listed for this compound. Additional details are available on the glycopyrrolate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Glyrx-pf

A generic version of GLYRX-PF was approved as glycopyrrolate by AM REGENT on July 23rd, 1986.

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Summary for GLYRX-PF
Drug patent expirations by year for GLYRX-PF
Drug Prices for GLYRX-PF

See drug prices for GLYRX-PF

Pharmacology for GLYRX-PF
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists

US Patents and Regulatory Information for GLYRX-PF

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Exela Pharma GLYRX-PF glycopyrrolate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 210997-001 Jul 11, 2018 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Exela Pharma GLYRX-PF glycopyrrolate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 210997-002 Jul 11, 2018 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Exela Pharma GLYRX-PF glycopyrrolate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 210997-003 Apr 9, 2020 RX Yes Yes ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Exela Pharma GLYRX-PF glycopyrrolate SOLUTION;INTRAMUSCULAR, INTRAVENOUS 210997-004 Dec 14, 2020 DISCN Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for GLYRX-PF (Glycopyrrolate)

Overview of GLYRX-PF

GLYRX-PF, a formulation of glycopyrrolate, is an anticholinergic medication used for various medical applications, including anesthesia, excessive salivation, and peptic ulcers. It is available in injectable solution form and has recently gained market approval for intravenous (IV) and intramuscular (IM) injection[4].

Market Size and Growth Projections

The glycopyrrolate market, which includes GLYRX-PF, is experiencing robust growth. The market is projected to expand significantly from 2023 to 2031, driven by positive market dynamics. This growth is attributed to increasing demand in hospitals, clinics, and other healthcare settings across geographical regions such as North America, Europe, Asia-Pacific, and others[1].

Market Segmentation

The glycopyrrolate market is segmented based on type (glycopyrrolate tablets and solutions) and application (hospitals, clinics, and other healthcare facilities). The solution form, which includes GLYRX-PF, is particularly popular due to its versatility in administration routes.

Type

  • Glycopyrrolate Tablets: Though less common, these are used for specific indications.
  • Glycopyrrolate Solutions: This segment, including GLYRX-PF, dominates the market due to its widespread use in medical procedures.

Application

  • Hospitals: The primary users of GLYRX-PF, given its role in preoperative and intraoperative care.
  • Clinics: Also significant users, especially for outpatient procedures.
  • Other: Includes nursing homes, emergency services, and other healthcare facilities.

Drivers of Market Growth

Several factors are driving the growth of the glycopyrrolate market, including GLYRX-PF:

Increasing Demand in Healthcare

The demand for glycopyrrolate is rising due to its efficacy in various medical applications. Its use in anesthesia and the reversal of neuromuscular blockade is particularly significant, contributing to its growing market share[4].

Expanding Healthcare Infrastructure

The growth of hospitals and clinics, especially in emerging economies, is increasing the demand for glycopyrrolate solutions like GLYRX-PF.

Regulatory Approvals

The FDA approval of GLYRX-PF, which does not contain benzyl alcohol, making it safe for use in neonates, has expanded its market potential[4].

Financial Trajectory

Pricing and Cost

The cost of GLYRX-PF varies depending on the quantity and pharmacy. For example, a 25-milliliter supply of the 0.2 mg/mL preservative-free solution can cost around $110. Generic versions are also available, which can influence pricing dynamics[2].

Revenue Projections

The glycopyrrolate market, including GLYRX-PF, is expected to generate significant revenue over the forecast period from 2023 to 2031. The market size is projected to grow in terms of value, measured in USD million, across different segments and geographical regions[1].

Competitive Landscape

The market for glycopyrrolate solutions like GLYRX-PF is competitive, with several key players involved:

Key Companies

  • Toobapharma
  • Infa Group
  • Suven Life Sciences Limited
  • Sharon
  • Tai Heng Industry Co. Ltd.
  • Stellar Chemical Laboratories Pvt
  • Invent Farma
  • Wuhan Shengtianyu[1]

Generic Competition

The availability of generic versions of glycopyrrolate solutions can impact the pricing and market share of branded products like GLYRX-PF. However, the unique formulation and FDA approval of GLYRX-PF help it maintain a competitive edge[2].

Economic and Regulatory Factors

Economic Demand

The price of prescription drugs, including GLYRX-PF, is largely determined by economic demand rather than production costs. Health insurance policies can also influence demand by shielding patients from the full cost of the medication[3].

Regulatory Compliance

GLYRX-PF has undergone rigorous regulatory scrutiny, including extractable and leachable studies to ensure the safety of its container closure system. This compliance is crucial for maintaining market approval and consumer trust[4].

Challenges and Opportunities

Challenges

  • Pricing Pressure: The presence of generic alternatives can exert pricing pressure on branded products.
  • Regulatory Hurdles: Continuous compliance with regulatory requirements, including post-approval submissions of leachable data, is necessary[4].

Opportunities

  • Expanding Applications: The versatility of glycopyrrolate solutions like GLYRX-PF in various medical procedures presents opportunities for market expansion.
  • Geographical Growth: Emerging markets in Asia-Pacific and other regions offer significant growth potential[1].

Consumer Behavior and Healthcare Trends

Patient Needs

The effectiveness of GLYRX-PF in addressing specific medical needs, such as preoperative antimuscarinic use and reversal of neuromuscular blockade, drives consumer demand.

Healthcare Trends

The increasing focus on patient safety and the need for effective medications in healthcare settings are trends that favor the growth of the glycopyrrolate market[4].

Key Takeaways

  • The glycopyrrolate market, including GLYRX-PF, is projected to experience robust growth from 2023 to 2031.
  • The market is driven by increasing demand in healthcare settings and expanding healthcare infrastructure.
  • Regulatory approvals and the absence of benzyl alcohol in GLYRX-PF are significant factors contributing to its market potential.
  • Economic demand and regulatory compliance are crucial for the financial trajectory of GLYRX-PF.
  • The market faces challenges from generic competition and regulatory hurdles but offers opportunities for expansion in emerging markets and new applications.

FAQs

Q: What is GLYRX-PF used for?

GLYRX-PF is used for various medical applications, including anesthesia, reversal of neuromuscular blockade, and treatment of peptic ulcers.

Q: How much does GLYRX-PF cost?

The cost of GLYRX-PF can vary, but a 25-milliliter supply of the 0.2 mg/mL preservative-free solution can cost around $110.

Q: Is GLYRX-PF safe for neonates?

Yes, GLYRX-PF is safe for neonates because it does not contain benzyl alcohol, unlike some other formulations.

Q: What are the key drivers of the glycopyrrolate market growth?

The key drivers include increasing demand in healthcare, expanding healthcare infrastructure, and regulatory approvals.

Q: Who are the key players in the glycopyrrolate market?

Key players include Toobapharma, Infa Group, Suven Life Sciences Limited, and others.

Sources

  1. Market Research Intellect, "Global Glycopyrrolate Market Size, Trends and Projections," December 2024.
  2. Drugs.com, "Glyrx-PF Prices, Coupons, Copay Cards & Patient Assistance."
  3. The American Journal of Managed Care, "The Price of Progress: Understanding Innovation and Affordability of Prescription Drugs," October 7, 2024.
  4. FDA, "NDA 210997: GLYRX-PF (glycopyrrolate) for intravenous (IV) and intramuscular (IM) injection," April 3, 2018.
  5. FDA, "GLYRX-PF Label Information," accessed December 20, 2024.

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