You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: April 18, 2025

Shilpa Company Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for Shilpa
International Patents:55
US Patents:5
Tradenames:12
Ingredients:12
NDAs:14
Patent Litigation for Shilpa: See patent lawsuits for Shilpa

Drugs and US Patents for Shilpa

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Shilpa DOCETAXEL docetaxel INJECTABLE;INJECTION 205934-003 Dec 22, 2015 AP RX Yes Yes 10,842,770 ⤷  Try for Free Y ⤷  Try for Free
Shilpa IMATINIB MESYLATE imatinib mesylate TABLET;ORAL 208302-002 Jan 17, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free
Shilpa ERLOTINIB HYDROCHLORIDE erlotinib hydrochloride TABLET;ORAL 211960-001 Nov 5, 2019 AB RX No No ⤷  Try for Free ⤷  Try for Free
Shilpa ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 208513-001 May 15, 2019 DISCN No No ⤷  Try for Free ⤷  Try for Free
Shilpa DOCETAXEL docetaxel INJECTABLE;INJECTION 205934-002 Dec 22, 2015 AP RX Yes Yes 10,842,770 ⤷  Try for Free Y ⤷  Try for Free
Shilpa DOCETAXEL docetaxel INJECTABLE;INJECTION 210327-003 May 16, 2019 AP RX No No ⤷  Try for Free ⤷  Try for Free
Shilpa CAPECITABINE capecitabine TABLET;ORAL 207456-002 Dec 12, 2016 AB RX No No ⤷  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

Supplementary Protection Certificates for Shilpa Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746976 LUC00026 Luxembourg ⤷  Try for Free PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL) (MOLECULAR WEIGHT 2000)-OXYCARBONYL)-1,2-DISTEAROYLPHOSPHATIDYL ETHANOLAMINE, E.G. IN THE MOLAR RATIO 3:2:0.015; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018
1746976 1790033-3 Sweden ⤷  Try for Free PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT.; REG. NO/DATE: EU/1/16/1130 20161008
0788360 SPC/GB04/021 United Kingdom ⤷  Try for Free PRODUCT NAME: BORTEZOMIB OR PHARMACEUTICALLY ACCEPTABLE ESTER THEREOF, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/274/001 20040428
0275821 01C0035 France ⤷  Try for Free PRODUCT NAME: ZOLEDRONIC ACID; NAT REG. NO/DATE: EU/1/01/176/001 20010320; FIRST REG.: LI IKS N 55 463 20001128
2962690 C 2019 032 Romania ⤷  Try for Free PRODUCT NAME: APREMILAST SAU O SARE ACCEPTABILA FARMACEUTIC A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/981; DATE OF NATIONAL AUTHORISATION: 20150115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/981; DATE OF FIRST AUTHORISATION IN EEA: 20150115
1746976 CA 2017 00030 Denmark ⤷  Try for Free PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018
1667986 92172 Luxembourg ⤷  Try for Free PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

In the dynamic world of pharmaceuticals, staying ahead of the competition is crucial for success. Today, we're diving deep into the competitive landscape of Shilpa Medicare Limited, a key player in the Indian pharmaceutical industry. We'll explore their market position, strengths, and strategic insights that are shaping their future in this ever-evolving sector.

Shilpa Medicare: A Brief Overview

Shilpa Medicare Limited, established in 1987, has grown from a modest beginning to become a significant force in the pharmaceutical industry. With a focus on niche APIs, intermediates, and formulations, Shilpa has carved out a unique position for itself in the market[1].

Core Business Areas

Shilpa Medicare's business is primarily divided into two main segments:

  1. Active Pharmaceutical Ingredients (APIs)
  2. Formulations

The company has shown particular expertise in oncology products, but it's not limited to this area. Shilpa's product portfolio spans across various therapeutic categories, showcasing its versatility and adaptability[2].

Market Position and Financial Performance

To understand Shilpa's competitive stance, let's look at its market position and recent financial performance.

Market Capitalization and Stock Performance

As of February 2025, Shilpa Medicare boasts a market capitalization of ₹7,171 Crores[7]. The company's stock has shown significant volatility, with a 52-week high/low range of ₹960 to ₹358[7]. This wide range indicates both the potential for growth and the inherent risks in the pharmaceutical sector.

Financial Metrics

Let's dive into some key financial metrics:

  • Revenue Growth: Shilpa Medicare has demonstrated a compound annual growth rate (CAGR) of 9% in sales over the past five years[7]. While this growth is positive, it's worth noting that it's considered relatively modest in the fast-paced pharmaceutical industry.

  • Profitability: The company's return on equity (ROE) stands at 1.71%, which is on the lower side[7]. This suggests there's room for improvement in terms of efficiently using shareholders' equity to generate profits.

  • Debt Position: On a positive note, Shilpa Medicare has managed to reduce its debt, which is a strong indicator of financial health[7].

Strengths and Competitive Advantages

Despite facing challenges, Shilpa Medicare has several strengths that position it well in the competitive landscape.

1. Diverse Product Portfolio

Shilpa's product range is impressively diverse. From oncology APIs to formulations, the company caters to various therapeutic areas. This diversification helps mitigate risks associated with dependence on a single product line[2].

2. Strong R&D Capabilities

The company's commitment to innovation is evident in its R&D efforts. With five dedicated R&D centers, Shilpa Medicare is continuously working on developing new products and improving existing ones[5].

3. Global Presence

Shilpa Medicare has successfully expanded its footprint beyond India. The company's products are exported to various international markets, including Europe and the USA[1]. This global presence not only diversifies revenue streams but also enhances the company's reputation on the world stage.

4. Vertical Integration

Shilpa Medicare's vertically integrated operations, supported by nine manufacturing facilities, allow for better control over the supply chain and quality of products[5]. This integration can lead to cost efficiencies and improved margins.

5. Intellectual Property Portfolio

With over 250 patents granted, Shilpa Medicare has built a strong intellectual property portfolio[5]. This not only protects the company's innovations but also creates potential licensing opportunities.

Strategic Initiatives and Future Outlook

Shilpa Medicare isn't resting on its laurels. The company has been making strategic moves to strengthen its market position and drive future growth.

Focus on Innovation

"We are very pleased with this approval from the SEC and hope to get the marketing approval soon. We are committed to working closely with regulatory authorities to bring this innovative treatment to patients as quickly as possible and are hopeful of launching it in India in the coming financial year. This NCE molecule approval exemplifies the true spirit of Shilpa, 'Innovating for affordable healthcare' keeping in mind the unmet needs of a large patient pool." - Vishnukant Bhutada, Managing Director of Shilpa Medicare[4]

This statement highlights Shilpa's commitment to innovation and addressing unmet medical needs. The company's recent approval for an Investigational New Drug (IND) for treating non-alcoholic fatty liver disease (NAFLD) is a testament to this focus[4].

Expansion into High-Growth Areas

Shilpa Medicare is strategically expanding into high-growth areas within the pharmaceutical industry. For instance:

  1. Biologics: The company is pursuing growth in the biologics segment, which is expected to be a major driver of pharmaceutical industry growth in the coming years[5].

  2. Transdermal Patches & Oral Dissolving Films: These novel drug delivery systems represent another area of focus for Shilpa, potentially opening up new market opportunities[5].

Leveraging AI for Drug Discovery

In a bold move towards the future of pharmaceuticals, Shilpa Medicare has introduced "NETRA AI," an advanced artificial intelligence-powered drug discovery platform[5]. This initiative could significantly reduce R&D timelines and costs, potentially giving Shilpa a competitive edge in drug development.

Challenges and Areas for Improvement

While Shilpa Medicare has many strengths, there are also areas where the company faces challenges:

1. Modest Sales Growth

The company's sales growth of 9.34% over the past five years is considered relatively low for the pharmaceutical industry[7]. Improving this growth rate will be crucial for Shilpa's long-term success.

2. Low Return on Equity

With an ROE of 1.71%, there's significant room for improvement in how efficiently Shilpa is using shareholders' equity to generate profits[7].

3. High Cost of Borrowing

The company's cost of borrowing appears to be on the higher side, which could impact profitability[7]. Managing this cost will be important for improving financial performance.

4. Decreasing Promoter Holding

Over the last three years, promoter holding in Shilpa Medicare has decreased by 5.79%[7]. While this doesn't necessarily indicate a problem, it's a trend worth monitoring as it could impact investor confidence.

Competitive Landscape

To truly understand Shilpa Medicare's position, we need to consider the broader competitive landscape of the Indian pharmaceutical industry.

Key Competitors

While a comprehensive competitor analysis is beyond the scope of this article, it's worth noting that Shilpa Medicare competes with both domestic and international pharmaceutical companies. Some of the key players in the Indian pharmaceutical market include Sun Pharmaceutical Industries, Dr. Reddy's Laboratories, and Lupin Limited.

Industry Trends

Several trends are shaping the competitive landscape:

  1. Increasing Focus on Specialty and Complex Generics: Many Indian pharmaceutical companies are moving up the value chain by focusing on these higher-margin products.

  2. Growing Importance of Biosimilars: As patents on many biologic drugs expire, the biosimilars market is expected to grow significantly.

  3. Digital Transformation: The use of AI and machine learning in drug discovery and development is becoming increasingly common.

  4. Emphasis on Quality: With increasing regulatory scrutiny, especially in export markets, maintaining high-quality standards is crucial.

SWOT Analysis

Let's summarize Shilpa Medicare's position using a SWOT analysis:

Strengths

  • Diverse product portfolio
  • Strong R&D capabilities
  • Global presence
  • Vertically integrated operations
  • Robust intellectual property portfolio

Weaknesses

  • Modest sales growth
  • Low return on equity
  • High cost of borrowing

Opportunities

  • Expansion into high-growth areas like biologics
  • Leveraging AI for drug discovery
  • Growing market for treatments of lifestyle diseases (e.g., NAFLD)

Threats

  • Intense competition in the pharmaceutical industry
  • Regulatory challenges in international markets
  • Potential for patent expirations

Future Outlook and Strategic Recommendations

Based on our analysis, Shilpa Medicare is well-positioned to grow, but there are areas where strategic focus could yield significant benefits:

  1. Accelerate Innovation: Continue to invest in R&D and leverage the NETRA AI platform to bring innovative products to market faster.

  2. Expand International Presence: While Shilpa already has a global footprint, there may be opportunities to expand further, particularly in emerging markets.

  3. Improve Operational Efficiency: Focus on improving return on equity and managing borrowing costs to enhance overall financial performance.

  4. Capitalize on Niche Markets: Continue to focus on specialized areas like oncology APIs where Shilpa has established expertise.

  5. Strategic Partnerships: Consider partnerships or collaborations to enter new therapeutic areas or geographic markets.

Key Takeaways

  • Shilpa Medicare has established itself as a significant player in the Indian pharmaceutical industry, with strengths in APIs and formulations.
  • The company's focus on innovation, as evidenced by its R&D investments and the introduction of AI-powered drug discovery, positions it well for future growth.
  • While facing challenges such as modest sales growth and low return on equity, Shilpa has opportunities in high-growth areas like biologics and novel drug delivery systems.
  • Strategic focus on operational efficiency, international expansion, and leveraging its strengths in niche markets could drive future success for Shilpa Medicare.

FAQs

  1. Q: What are Shilpa Medicare's main business segments? A: Shilpa Medicare's main business segments are Active Pharmaceutical Ingredients (APIs) and Formulations.

  2. Q: How has Shilpa Medicare's stock performed recently? A: As of February 2025, Shilpa Medicare's stock has shown significant volatility, with a 52-week high/low range of ₹960 to ₹358.

  3. Q: What is NETRA AI? A: NETRA AI is an advanced artificial intelligence-powered drug discovery platform introduced by Shilpa Medicare to revolutionize the drug development process.

  4. Q: What are some of the challenges facing Shilpa Medicare? A: Some challenges include modest sales growth, low return on equity, and high cost of borrowing.

  5. Q: What are some key trends in the pharmaceutical industry that could affect Shilpa Medicare? A: Key trends include increasing focus on specialty and complex generics, growing importance of biosimilars, digital transformation, and emphasis on quality standards.

Sources cited: [1] https://www.marketscreener.com/quote/stock/SHILPA-MEDICARE-LIMITED-46729794/company/ [2] https://stockdiscovery.s3.amazonaws.com/india/company/3315/2279/AR-23.pdf [4] https://www.business-standard.com/markets/news/here-s-why-shilpa-medicare-share-price-jumped-8-in-trade-on-february-13-125021300839_1.html [5] https://pharmaoffer.com/blog/press_release/shilpa-medicare-limited-announces-multiple-milestones-in-innovation-and-global-approvals/ [7] https://www.screener.in/company/SHILPAMED/consolidated/

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.