PRECOSE Drug Patent Profile

Which patents cover Precose, and what generic alternatives are available?

Precose is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in PRECOSE is acarbose. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acarbose profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Precose

A generic version of PRECOSE was approved as acarbose by HIKMA on May 7^th, 2008.

Summary for PRECOSE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	40
Clinical Trials:	8
Patent Applications:	23
Drug Prices:	Drug price information for PRECOSE
What excipients (inactive ingredients) are in PRECOSE?	PRECOSE excipients list
DailyMed Link:	PRECOSE at DailyMed

See drug prices for PRECOSE

Recent Clinical Trials for PRECOSE

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

Sponsor	Phase
Montefiore Medical Center	Phase 2
Zhongda Hospital	Phase 4
University of British Columbia	Phase 2

See all PRECOSE clinical trials

Paragraph IV (Patent) Challenges for PRECOSE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PRECOSE	Tablets	acarbose	25 mg, 50 mg and 100 mg	020482	1	2005-03-22

US Patents and Regulatory Information for PRECOSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-004	May 29, 1997		DISCN	Yes	No
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-001	Sep 6, 1995		DISCN	Yes	No
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-002	Sep 6, 1995		DISCN	Yes	No

Expired US Patents for PRECOSE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-004	May 29, 1997	4,904,769
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-001	Sep 6, 1995	4,904,769
Bayer Hlthcare	PRECOSE	acarbose	TABLET;ORAL	020482-002	Sep 6, 1995	4,904,769

International Patents for PRECOSE

See the table below for patents covering PRECOSE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	S62155288	HIGH PURITY ACARUBOSE
Hungary	T43083
Denmark	164870
Austria	71951
Denmark	598686

Market Dynamics and Financial Trajectory for PRECOSE

Last updated: March 8, 2026

What is PRECOSE and its current regulatory status?

PRECOSE (acarbose) is an alpha-glucosidase inhibitor used to delay carbohydrate absorption in type 2 diabetes. It has U.S. Food and Drug Administration (FDA) approval since 1995 for managing postprandial blood glucose levels. The drug is marketed primarily by Bayer and some generic manufacturers.

How large is the market for PRECOSE and related drugs?

The global market for alpha-glucosidase inhibitors was valued at approximately USD 400 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of roughly 5.5% from 2023 to 2030, driven by increasing type 2 diabetes prevalence and the demand for oral medications.

Key regions:

• North America: accounts for 45% of sales, driven by high diabetes rates and reimbursement coverage.
• Europe: 30%, with steady growth due to aging populations.
• Asia-Pacific: 20%, fastest growth driven by rising diabetes incidence and increasing access to healthcare.
• Rest of the world: 5%.

What are the major drivers influencing PRECOSE’s market?

1. Prevalence of Type 2 Diabetes: In 2021, an estimated 537 million adults had diabetes globally, expected to reach 643 million by 2030. This increase fuels demand for glucose-lowering drugs.

2. Physician and Patient Preferences: Oral therapies like PRECOSE are chosen for their convenience over injectables. Patient adherence improves with tolerability and perceived effectiveness.

3. Pricing and Reimbursement Policies: In developed markets, pre-approval reimbursement maintains sales levels. Price competition with generics reduces margins but expands access.

4. Competitive Landscape: Bayer’s monopoly is challenged by generics entering after patent expiry in 2018. Several companies are developing combination therapies incorporating acarbose.

How does the patent environment influence market outlook?

PRECOSE’s patent expired in 2018, shifting market share to generics. No new patent filings or exclusivity extensions are noted since then. Patent expiration led to a 15-20% drop in Bayer’s sales in 2019.

New formulations or combination drugs could extend lifecycle:

• Combination with metformin or SGLT2 inhibitors.
• Extended-release formulations.

These innovations may provide some patent barriers post-2018 but face competition from established generics.

What are the sales trends and financial projections?

Historical sales (Bayer, 2015–2022):	Year	Sales (USD millions)	Notes
2015	155	Post-approval
2017	180	Steady growth
2018	185	Patent expiry
2019	149	Drop post-generic entry
2020	152	Stabilization
2021	160	Slight rebound
2022	165	Mild growth

Projected (2023–2030):
Sales are expected to stabilize around USD 150-170 million annually, with incremental growth driven by increased adoption of combination therapies and major markets adopting biosimilars.

What are the key risks and opportunities?

Risks:

• Entry of newer agents like SGLT2 inhibitors reducing demand.
• Pricing pressures in mature markets.
• Regulatory shifts affecting drug approval or reimbursement.

Opportunities:

• Development of fixed-dose combinations.
• Expansion into emerging markets.
• Clinical research supporting claims for improved metabolic control.

Key competitive landscape

Company	Product development focus	Patent status	Market share estimates
Bayer	Generic acarbose, combination formulations	Patent expired 2018	Approx. 60% in markets where proprietary formulations still available
Teva, Sandoz	Generics	Patent expired	30-40%, mainly via generics
Novo Nordisk, Lilly	New combination therapies or alternatives	N/A	Niche, focused on GLP-1 receptor agonists

Summary of financial drivers

Limited growth prospects post-patent expiry suggest a mature product. Future revenue depends on innovation, regional expansion, and competitive pricing. The core market will be sustained by the global diabetes burden but will face significant competition from newer therapeutic classes.

Key Takeaways

• PRECOSE's global sales peaked pre-2018; post-patent expiry sales declined but stabilized.
• The global alpha-glucosidase inhibitor market is growing slowly, at around 5.5% CAGR.
• Market share shifted heavily to generics after patent expiration.
• Growth opportunities hinge on combination formulations and regional expansion.
• Competitive pressures and alternative drug classes limit long-term revenue potential.

Frequently Asked Questions

1. What factors led to the decline in PRECOSE sales after patent expiry?

Patent expiry in 2018 allowed generics to enter at lower prices, reducing Bayer’s market share and sales. Market saturation and competition from newer drug classes further contributed.

2. Can PRECOSE regain market share through formulation innovation?

Limited innovation efforts have been reported. Developing new formulations or combination therapies could provide some market advantage but face patent challenges and competitive threats.

3. How does the rise of SGLT2 inhibitors and GLP-1 agonists affect PRECOSE’s prospects?

These newer classes show higher efficacy and cardiovascular benefits, leading physicians to prefer them over alpha-glucosidase inhibitors, constraining PRECOSE’s growth.

4. What are the key regional markets for PRECOSE?

North America, Europe, and Asia-Pacific are primary, with Asia-Pacific experiencing the fastest growth due to rising diabetes rates.

5. What future strategies could sustain PRECOSE sales?

Focusing on combination therapies, entering emerging markets, and developing extended-release formulations are potential strategies.

---

References

1. International Diabetes Federation. (2022). IDF Diabetes Atlas, 10th edition. https://www.diabetesatlas.org.
2. IQVIA. (2023). Global Pharmacovigilance Market Report.
3. Bayer AG. (2022). Annual Report. https://www.bayer.com.
4. EvaluatePharma. (2023). Pharmaceutical Market Outlook.