ANI PHARMS Company Profile

What is the competitive landscape for ANI PHARMS

ANI PHARMS has two hundred and forty-eight approved drugs.

There are seven US patents protecting ANI PHARMS drugs. There is one tentative approval on ANI PHARMS drugs.

There are twenty-nine patent family members on ANI PHARMS drugs in twenty countries and one hundred and eighty-six supplementary protection certificates in sixteen countries.

Summary for ANI PHARMS

International Patents:	29
US Patents:	7
Tradenames:	158
Ingredients:	151
NDAs:	248

Drugs and US Patents for ANI PHARMS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	FLUCONAZOLE	fluconazole	TABLET;ORAL	076086-003	Jul 29, 2004		DISCN	No	No
Ani Pharms	TEMOZOLOMIDE	temozolomide	CAPSULE;ORAL	203490-005	Jul 13, 2016		DISCN	No	No
Ani Pharms	VANCOCIN HYDROCHLORIDE	vancomycin hydrochloride	FOR SOLUTION;ORAL	061667-002	Jul 13, 1983	AA	RX	No	Yes
Ani Pharms	NEBIVOLOL HYDROCHLORIDE	nebivolol hydrochloride	TABLET;ORAL	203659-001	Apr 16, 2015	AB	RX	No	No
Ani Pharms	ETODOLAC	etodolac	CAPSULE;ORAL	075126-002	Sep 16, 1999	AB	RX	No	No
Ani Pharms	PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	071977-001	Apr 6, 1988		DISCN	No	No
Ani Pharms	OXYCODONE HYDROCHLORIDE	oxycodone hydrochloride	SOLUTION;ORAL	203447-001	Aug 30, 2017		DISCN	No	No

Expired US Patents for ANI PHARMS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000	5,703,110
Ani Pharms	ATACAND	candesartan cilexetil	TABLET;ORAL	020838-001	Jun 4, 1998	7,538,133*PED
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000	5,534,534*PED
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-001	Sep 5, 2000	5,705,517*PED
Ani Pharms	ATACAND HCT	candesartan cilexetil; hydrochlorothiazide	TABLET;ORAL	021093-002	Sep 5, 2000	5,196,444*PED
Ani Pharms	VEREGEN	sinecatechins	OINTMENT;TOPICAL	021902-001	Oct 31, 2006	5,968,973
Ani Pharms	ARIMIDEX	anastrozole	TABLET;ORAL	020541-001	Dec 27, 1995	4,935,437

Paragraph IV (Patent) Challenges for ANI PHARMS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	for Injection	100 mcg/vial and 500 mcg/vial		2015-04-14
	Tablets	4 mg, 8 mg, 16 mg and 32 mg		2006-12-22
	Tablets	32 mg/25 mg		2009-03-06
	for Injection	200 mcg/vial		2015-05-01
	Tablets	16 mg/12.5 mg and 32 mg/12.5 mg		2008-06-25

International Patents for ANI PHARMS Drugs

Country	Patent Number	Estimated Expiration
Portugal	1448186
Brazil	0214256
Japan	4495459
Germany	10156794
South Africa	200403287
Hong Kong	1073788
Argentina	037526

Supplementary Protection Certificates for ANI PHARMS Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2932970	18C1043	France		PRODUCT NAME: UNE COMBINAISON COMPRENANT DU DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI,EN PARTICULIER LE SEL DE SODIUM DU DOLUTEGRAVIR,ET DE LA RILPIVIRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,EN PARTICULIER LE CHLORHYDRATE DE RILPIVIRINE; REGISTRATION NO/DATE: EU/1/18/1282 20180518
0454511	99C0009	Belgium		PRODUCT NAME: IRBESARTAN / HYDROCHLOROTHIAZIDE; REGISTRATION NO/DATE: EU/1/98/086/001 19981015
1539166	60/2013	Austria		PRODUCT NAME: KOMBINATION VON A) DEXTROMETHORPHAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE DEXTROMETHORPHANHYDROBROMID, UND INSBESONDERE DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT UND B) CHINIDIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE CHINIDINSULFAT, UND INSBESONDERE CHINIDINSULFATDIHYDRAT.; REGISTRATION NO/DATE: EU/1/13/833 20130626
0502314	SPC/GB02/037	United Kingdom		PRODUCT NAME: TELMISARTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, AND HYDROCHLOROTHIAZIDE; REGISTERED: UK EU/1/02/213/001 20020419; UK EU/1/02/213/002 20020419; UK EU/1/02/213/003 20020419; UK EU/1/02/214/004 20020419; UK EU/1/02/213/005 20020419; UK EU/1/02/213/006 20020419; UK EU/1/02/213/007 20020419; UK EU/1/02/213/008 20020419; UK EU/1/02/213/009 20020419; UK EU/1/02/213/010 20020419
2380576	2020/043	Ireland		PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; NAT REGISTRATION NO/DATE: PA2103/003/001 20170602; FIRST REGISTRATION NO/DATE: SE/H/1547/001/DC 20160729
2340828	LUC00195	Luxembourg		PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
0306228	C300034	Netherlands		PRODUCT NAME: ROSIGLITAZONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT EN/OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT, IN HET BIJZONDER ROSIGLITAZONE MALEAAT; REGISTRATION NO/DATE: EU/1/00/137/001 - EU/1/00/137/012 20000711

Similar Applicant Names

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• Ani Pharms

Pharmaceutical Competitive Landscape Analysis: Ani Pharms – Market Position, Strengths & Strategic Insights

Last updated: July 28, 2025

Introduction

Ani Pharms has emerged within the highly competitive pharmaceutical industry as a notable player, carving a niche through distinctive product offerings and strategic initiatives. This analysis evaluates Ani Pharms’ market position, core strengths, and strategic opportunities essential for sustainable growth amid evolving industry dynamics.

Market Position of Ani Pharms

Ani Pharms operates primarily in the generic and specialty pharmaceutical sectors, emphasizing high-demand therapeutic areas such as oncology, infectious diseases, and chronic conditions. Its market positioning is characterized by niche specialization and geographical focus, predominantly in emerging markets and select developed regions.

The company has demonstrated solid revenue growth over recent years, largely driven by expanding product portfolios, strategic licensing agreements, and acquisitions of regional pharmaceutical companies. Its market share remains competitive within targeted therapeutic segments, benefiting from increasing global demand for affordable medications.

However, Ani Pharms faces intensifying competition from both multinational giants like Pfizer and Novartis, and regional firms leveraging local market insights. The company's ability to differentiate hinges on innovation, regulatory agility, and supply chain resilience.

Core Strengths of Ani Pharms

1. Focused Product Portfolio

Ani Pharms emphasizes high-margin therapeutics within specialized niches, including oncology, antiviral agents, and rare disease treatments. This targeted approach minimizes direct price competition and enhances brand recognition within these segments.

2. Robust R&D Capabilities

Investments in research and development underpin Ani Pharms’ capacity to develop biosimilars, generics, and novel formulations. The company's R&D pipeline prioritizes unmet medical needs, fostering partnerships with biotech firms and academic institutions.

3. Cost-Effective Manufacturing

Ani Pharms benefits from strategically located manufacturing facilities that enable cost efficiencies. Its operational excellence in production processes, including quality compliance, facilitates competitive pricing and reliable supply chains.

4. Strategic Alliances and Licensing

Agreements with global pharmaceutical innovators for licensing and co-development bolster Ani Pharms’ market access and diversify its therapeutic portfolio. These partnerships often expedite regulatory approvals and market entry.

5. Regulatory Expertise in Key Markets

Strong regulatory expertise allows Ani Pharms to navigate complex approval pathways swiftly. This capability is critical for timely product launches and sustaining intellectual property rights.

Strategic Insights and Opportunities

1. Geographic Diversification

Expanding into emerging markets such as Southeast Asia, Latin America, and Africa offers growth prospects through increasing healthcare infrastructure and demand for affordable medicines. Tailoring regulations and market entry strategies is essential.

2. Investment in Biosimilar Development

With the global biosimilar market projected to grow significantly (expected to reach USD 74 billion by 2025), Ani Pharms should prioritize biosimilar pipeline expansion. Developing biosimilars for blockbuster biologics can deliver high revenue margins and competitive differentiation.

3. Digital Transformation and Data Analytics

Leveraging digital platforms for supply chain optimization, pharmacovigilance, and market analytics can improve efficiency and responsiveness. Adoption of AI-driven drug discovery can accelerate pipeline development and reduce R&D costs.

4. Enhance Intellectual Property Strategies

Aggressive patent filing, strategic patent litigation, and licensing negotiations are key to maintaining exclusivity and revenue streams. Protecting proprietary formulations and manufacturing processes sustains competitive advantage.

5. Strategic Acquisitions and Partnerships

Acquiring regional firms or forming alliances with biotech innovators can expand ANI’s market reach and technological capabilities. Targeted acquisitions can also facilitate diversification into adjacent sectors such as diagnostics and personalized medicine.

Challenges and Risk Mitigation

While opportunities abound, ANI Pharms faces significant challenges including pricing pressures from payers, regulatory variability across jurisdictions, and potential supply chain disruptions. Building resilience through diversified manufacturing locations, investing in regulatory intelligence, and maintaining robust quality assurance practices are critical mitigating strategies.

Competitive Landscape Overview

Ani Pharms operates amidst a vibrant and consolidated industry landscape, with key competitors including:

• Multinational Active Pharmaceutical Ingredients (API) producers and generic pharmaceutical firms (e.g., Teva, Mylan/Merck)
• Regional players with localized manufacturing and distribution networks
• Biotech firms venturing into biologics and biosimilars

Ani Pharms’ differentiated approach—focusing on niche therapeutic areas, cost-effective operations, and strategic alliances—positions it well to compete effectively, provided it continues to innovate and adapt to market shifts.

Conclusion

Ani Pharms has established a resilient market position through focused product development, strategic collaborations, and operational efficiencies. To sustain growth and enhance competitiveness, it must accelerate biosimilar development, expand geographically, and harness digital transformation. Focusing on these strategic avenues will enable Ani Pharms to navigate industry challenges and capitalize on emerging opportunities effectively.

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Key Takeaways

• Ani Pharms’ niche specialization and strategic alliances underpin its competitive edge amidst industry consolidation.
• Prioritizing biosimilar pipeline expansion offers significant revenue potential aligned with industry growth forecasts.
• Geographic diversification enhances growth prospects, especially in emerging markets with rising healthcare demands.
• Digital transformation initiatives can streamline operations, reduce costs, and accelerate drug development.
• Robust IP management and strategic acquisitions are vital for sustaining market exclusivity and expanding technological capabilities.

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FAQs

Q1: What are the primary therapeutic areas Ani Pharms focuses on?
A1: Ani Pharms concentrates on oncology, antiviral agents, and rare diseases, leveraging niche markets to avoid direct price competition and foster specialized expertise.

Q2: How does Ani Pharms differentiate itself from larger competitors?
A2: Through focused therapeutic portfolios, cost-efficient manufacturing, rapid regulatory navigation, and strategic licensing partnerships, Ani Pharms offers targeted solutions with agility unmatched by larger firms.

Q3: What growth opportunities exist for Ani Pharms in emerging markets?
A3: Emerging markets present opportunities due to increasing healthcare infrastructure, rising patient populations, and demand for affordable medications, provided Ani Pharms tailors its market entry approaches effectively.

Q4: Why is biosimilar development critical for Ani Pharms’ future?
A4: The global biosimilar market is expanding rapidly, offering high margins and growth potential. Developing biosimilars can help Ani Pharms compete in high-value biologic segments and expand market share.

Q5: What strategic risks does Ani Pharms face, and how can they mitigate these?
A5: Risks include pricing pressures, regulatory hurdles, and supply chain disruptions. Mitigation strategies involve diversifying manufacturing, investing in regulatory expertise, and building resilient supply networks.

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Sources

1. Pharmaceutical Industry Outlook 2023
2. Global Biosimilars Market Report
3. Emerging Markets Healthcare Growth
4. Digital Transformation in Pharma
5. Intellectual Property Strategies in Pharma