Biguanide Drug Class List

Drugs in Drug Class: Biguanide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005		DISCN	Yes	No	9,320,714		Y
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-001	Aug 29, 2005		DISCN	Yes	No	9,101,660		Y
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-002	Aug 29, 2005	AB	RX	Yes	Yes	9,101,660		Y
Takeda Pharms Usa	ACTOPLUS MET	metformin hydrochloride; pioglitazone hydrochloride	TABLET;ORAL	021842-002	Aug 29, 2005	AB	RX	Yes	Yes	9,320,714		Y
Teva Pharms	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	glipizide; metformin hydrochloride	TABLET;ORAL	077270-001	Oct 28, 2005	AB	RX	No	No
Teva Pharms	GLIPIZIDE AND METFORMIN HYDROCHLORIDE	glipizide; metformin hydrochloride	TABLET;ORAL	077270-002	Oct 28, 2005	AB	RX	No	No

Biguanide Market Analysis and Financial Projection

The global biguanide market, driven primarily by the demand for diabetes treatments like metformin, is characterized by steady growth, regional disparities, and evolving intellectual property strategies. Here's a detailed analysis:

---

Market Dynamics

Growth Drivers

• Diabetes Epidemic: Rising type 2 diabetes prevalence (over 537 million cases globally) fuels demand for biguanides, the first-line oral antidiabetic therapy[1][12][18].
• Cost-Effectiveness: Generics dominate due to metformin's affordability, with branded drugs holding 87.4% market share in 2023[18].
• Formulation Innovations: Extended-release (XR) formulations (e.g., Glucophage XR) improve compliance, driving growth with XR segment projected to reach $3.6 billion by 2032[7][18].
• Geographic Expansion: Asia-Pacific leads (37.9% market share in 2023) due to high diabetes rates in India and China, while North America targets $1.59 billion by 2030[1][3][12].

Challenges

• Generic Saturation: Post-patent expirations (e.g., metformin) intensify price competition[4][15].
• Safety Concerns: Risks like lactic acidosis limit broader applications[4].
• Alternative Therapies: Emerging GLP-1 agonists and SGLT2 inhibitors threaten market share[12].

Emerging Opportunities

• Beyond Diabetes: Research explores biguanides in oncology (adjuvant therapy), cardiovascular disease, and polycystic ovary syndrome[4][12].
• Digital Integration: Partnerships with digital health platforms (e.g., glucose monitoring apps) enhance treatment adherence[12][18].

---

Patent Landscape

Key Patent Trends

1. Formulation Innovations:

   • Controlled-Release Patents: US6866866 and US8475841 cover XR metformin formulations targeting reduced dosing frequency[8][10].
   • Combination Therapies: US9060941B2 protects metformin/pioglitazone combinations (e.g., ActosPlus Met), extending therapeutic utility[11].

2. Manufacturing Processes:

   • Derivatives like polyhexamethylene biguanide (PHMB) for water treatment (WO1997004655A1) and antimalarial agents (US2467371A) showcase non-diabetic applications[2][9].

3. Litigation & Expirations:

   • Patent Cliffs: Dapagliflozin/metformin (expiring 2024–2028) and sitagliptin/metformin (Januvia/JANUMET, expiring 2026–2029) will boost generics[15][17].
   • Legal Disputes: Takeda defended pioglitazone patents in 2006 against generic challengers, while Merck faced term-extension disputes over sitagliptin/metformin combinations[5][16].

Strategic Responses

• Evergreening: Companies like Andrx Labs prioritize XR formulations to extend exclusivity[8][10].
• Geographic Diversification: Focus on Latin America ($443.91 million by 2029) and Africa, where diabetes is underdiagnosed[6][12].

---

Regional Insights

Region	2023 Market Size	Key Trends
Asia-Pacific	$2.2 billion	High population density, government diabetes initiatives[1][12].
North America	$1.4 billion	Dominance of branded drugs, digital health integration[3][18].
Europe	$1.1 billion	Aging population, emphasis on combination therapies[1][12].

---

Future Outlook

• Technological Advances: Nanotechnology and personalized medicine may enable targeted biguanide delivery[4][12].
• Regulatory Pressures: Stricter safety protocols for generics could slow market entry[4].
• Sustainability: PHMB-based water treatments present non-pharma growth avenues[9][14].

"The dual challenge of patent cliffs and generic saturation requires biguanide manufacturers to innovate beyond traditional formulations." – Market Analyst, GreyB Insights[15]

---

Conclusion

The biguanide market remains resilient due to diabetes prevalence but faces headwinds from generics and novel therapies. Strategic patent management, geographic expansion, and diversification into non-diabetic applications will define long-term success. Meanwhile, legal battles over combination drugs and formulation patents underscore the importance of robust IP strategies.

References

1. https://ultramarketresearch.com/report/global-biguanide-market
2. https://patents.google.com/patent/US2467371A/en
3. https://www.mordorintelligence.com/industry-reports/north-america-biguanide-market
4. https://www.giiresearch.com/report/ires1579433-biguanides-market-by-type-finformin-metformin-drug.html
5. https://casetext.com/case/takeda-chemical-industries-2
6. https://www.researchandmarkets.com/report/latin-america-biguanide-market
7. https://www.polarismarketresearch.com/industry-analysis/biguanides-market
8. https://www.drugpatentwatch.com/p/patent/6866866
9. https://patents.google.com/patent/WO1997004655A1/en
10. https://pubchem.ncbi.nlm.nih.gov/patent/US8475841
11. https://patents.google.com/patent/US9060941B2/en
12. https://markwideresearch.com/biguanides-market/
13. https://pubchem.ncbi.nlm.nih.gov/patent/US-10668031-B2
14. https://patents.justia.com/patent/5376686
15. https://www.greyb.com/blog/diabetes-drug-patents-expiring/
16. https://www.mbip.com.au/patent-term-extensions-in-australia-and-beyond-part-4/
17. https://www.merck.com/news/u-s-district-court-rules-in-favor-of-merck-in-sitagliptin-phosphate-patent-lawsuit/
18. https://www.gminsights.com/industry-analysis/biguanides-market