Last Updated: June 23, 2026

PIRMELLA 1/35 Drug Patent Profile


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When do Pirmella 1/35 patents expire, and what generic alternatives are available?

Pirmella 1/35 is a drug marketed by Lupin Ltd and is included in one NDA.

The generic ingredient in PIRMELLA 1/35 is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

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Questions you can ask:
  • What is the 5 year forecast for PIRMELLA 1/35?
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  • What is Average Wholesale Price for PIRMELLA 1/35?
Summary for PIRMELLA 1/35
US Patents:0
Applicants:1
NDAs:1
DailyMed Link:PIRMELLA 1/35 at DailyMed

US Patents and Regulatory Information for PIRMELLA 1/35

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd PIRMELLA 1/35 ethinyl estradiol; norethindrone TABLET;ORAL-28 201512-001 Apr 24, 2013 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Last updated: April 26, 2026

PIRMELLA 1/35: Market Dynamics and Financial Trajectory

PIRMELLA 1/35 is a brand of a combined oral contraceptive (COC) containing ethinyl estradiol 0.035 mg (35 mcg) and levonorgestrel 1.0 mg. Market performance for this specific brand depends on country-specific launch timing, listing status, tender cycles, pharmacy channel strength, and competitor intensity in the levonorgestrel 30–35 mcg COC segment. The financial trajectory is shaped primarily by (i) pricing pressure from generics and authorized generic entrants, (ii) formulary positioning and reimbursement dynamics (where applicable), and (iii) marketing spend efficiency in a mature therapy class with low differentiation.

What is PIRMELLA 1/35 and what market segment does it sit in?

PIRMELLA 1/35 is a progestin-estrogen COC using levonorgestrel and ethinyl estradiol at 1.0 mg / 0.035 mg. As a COC brand, it competes inside a large, mature market characterized by high substitution, frequent price changes via tenders/insurers, and rapid erosion of premium pricing after authorized-generic and generic penetration.

Core product identity

Attribute PIRMELLA 1/35
Actives Levonorgestrel + Ethinyl estradiol
Strength 1 mg + 0.035 mg (35 mcg)
Class Combined oral contraceptive
Competitive set Levonorgestrel 30–35 mcg COCs and switching-friendly COCs

How do market dynamics typically play out for 35 mcg levonorgestrel COCs?

COC markets are structurally stable but financially sensitive to procurement and switching economics. For products at this strength level, the typical dynamics are:

  1. Rapid substitution risk

    • COCs are substitutable at the class level in many jurisdictions, and switching between brands in the same dosing window is common when price gaps widen.
  2. Pricing compression

    • Retail and private-pay pricing tends to track wholesale and generic reference pricing.
    • In markets with public procurement or insurer formularies, pricing resets to the lowest acceptable offer.
  3. Distribution and formulary pull

    • Brands win primarily through access: pharmacy distribution, inclusion on insurer formularies, and tender eligibility.
  4. Promotion efficiency

    • Because clinical differentiation is limited across many COCs, demand lift relies on brand recognition and promo intensity, which usually decays post-launch.
  5. Regulatory and supply continuity

    • COC demand is recurring, so stock-outs and supply disruptions can cause durable share loss if patients cycle into other brands.

What determines PIRMELLA 1/35 financial trajectory (revenue and margin) over time?

PIRMELLA 1/35’s financial path is best explained by three drivers:

1) Share capture at launch versus generics overwriting premium

  • Launch phase: revenue growth tends to be driven by brand availability, initial prescriber uptake, and retailer/sales-force push.
  • Post-penetration: price competition typically accelerates as alternative levonorgestrel 35 mcg products and lower-price equivalents gain shelf position and physician familiarity.

2) Gross margin sensitivity

Margins compress when:

  • wholesale acquisition cost rises relative to net sales due to competitive discounting,
  • rebates expand to win tenders or insurer contracts,
  • manufacturing economies cannot outpace volume growth.

Margins stabilize when:

  • the brand sustains differentiated access (preferred listing, stable contracts),
  • supply reliability reduces discounting tied to stock strategy.

3) Working capital and inventory

COCs are “steady use” products, but seasonal demand swings and tender-driven stock build can tighten working capital. A key financial inflection point usually occurs when:

  • volume growth outpaces inventory turnover goals, or
  • price resets force inventory repricing.

What are the most likely competitive pressures in the COC band that include PIRMELLA 1/35?

Competitors usually include:

  • Other levonorgestrel/ethinyl estradiol 30–35 mcg brands
  • Authorized generics and generics of equivalent dosing
  • Slight reformulation competitors (different progestin brands) that gain share through pricing or formulary selection

From a business perspective, the relevant comparison is not clinical differentiation but net price and access. Even small pricing differences can shift demand quickly.

How does this translate into a typical revenue curve for a brand like PIRMELLA 1/35?

A typical brand-level trajectory in mature COCs looks like:

  • Early period: growth as the brand establishes distribution and clinician/patient awareness
  • Mid period: plateau as competitor equivalents stabilize and substitution rises
  • Later period: share and net price erosion unless the brand maintains favored access or cost advantages

For PIRMELLA 1/35, the financial trajectory depends on whether it maintains a pricing position consistent with:

  • insurer/formulary listing,
  • tender awards,
  • persistent pharmacy shelf placement.

What can be concluded without assuming specific country revenue figures?

This brief cannot produce a numeric market size, CAGR, or brand-level revenue/margin trajectory for PIRMELLA 1/35 without country-specific financial disclosures, procurement datasets, or retail pricing histories. What can be stated precisely is the economic mechanism that governs outcomes:

  • In levonorgestrel 1 mg / ethinyl estradiol 35 mcg COCs, brand value correlates with access and net price, not clinical superiority.
  • Financial performance usually exhibits pricing compression and share volatility after generic/authorized-generic entry in the same dosing band.

Business actions that align with these dynamics (for investment or R&D planning)

Even for a known molecule and dosing, the correct commercial lens is access and cost-to-serve.

Commercial due diligence checks

  • Contracting position: tender and payer placement stability
  • Discount ladder: whether net price erosion is offset by volume
  • Forecasting: inventory cycles around procurement windows
  • Shelf share: pharmacy channel strength and substitution rates

R&D and portfolio implications

  • If the strategy is to extend the franchise, differentiation typically must come from:
    • formulation/process improvements that reduce total cost to manufacture,
    • access-driven lifecycle management (new pack sizes, compliance formats where allowed),
    • channel expansion rather than therapeutic claims that are already crowded.

Key Takeaways

  • PIRMELLA 1/35 is a levonorgestrel 1 mg / ethinyl estradiol 35 mcg combined oral contraceptive brand competing in a high-substitution, pricing-sensitive segment.
  • The brand’s financial trajectory is driven primarily by formulary/tender access, net pricing, and cost-to-serve, not by clinical differentiation.
  • Expected performance pattern in this category is launch growth, mid-term plateau, and later price pressure unless the brand preserves preferred access or achieves manufacturing and commercial cost advantages.

FAQs

  1. Is PIRMELLA 1/35 a branded innovator or a commodity COC?
    It is a COC brand in a mature dosing band where substitution and generic dynamics usually dominate economics.

  2. What most affects revenue for PIRMELLA 1/35?
    Net price and access, including pharmacy distribution strength and payer or tender placement.

  3. How quickly does margin typically compress in 35 mcg levonorgestrel COCs?
    After equivalent offerings proliferate, discounts and rebates tend to expand, compressing gross margin unless cost position improves.

  4. What determines whether the brand holds share?
    The brand’s ability to maintain shelf position and contract continuity while competitor equivalents match therapeutic equivalence.

  5. What is the main risk to a COC brand like PIRMELLA 1/35?
    Pricing resets driven by authorized generics and generics plus substitution to lower-priced equivalents.

References

[1] United States Food and Drug Administration (FDA). Drug Label Information for Oral Contraceptives (Ethinyl Estradiol and Levonorgestrel). FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] World Health Organization (WHO). Oral Contraceptives: Guidance on Use and Safety (ethinyl estradiol/progestin combinations). WHO. https://www.who.int/health-topics/contraception
[3] European Medicines Agency (EMA). Combined Oral Contraceptives (ethinyl estradiol and progestogens) product information and assessments. EMA. https://www.ema.europa.eu/

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